Protecting Human Research Participants

Secretary of Health and Human Services Tommy Thompson recently appointed committee members to his Department’s new Secretary’s Advisory Committee on Human Research Protection (SACHRP) and the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS). (See Update, November 4, 2002).

On January 3, 2003, 11 individuals were named to SACHRP, which replaces the defunct National Human Research Protections Advisory Committee (NHRPAC). SACHRP will be chaired by Ernest Prentice, Associate Dean for Research and Vice Chancellor for Academic Affairs and Regulatory Compliance at the University of Nebraska Medical School in Omaha.

Three of the former NHRPAC committee members were named to SACHRP: Mark Barnes (health care attorney and Partner, Ropes & Gray), Susan Kortensky, (Director of Clinical Research Compliance, Children’s Hospital, Boston), and Jonathan Moreno, (Professor of Bioethics, University of Virginia). It has been reported, however, that Moreno, has declined to serve as a member of the new committee and that he is urging that his “vacant seat be filled by a research subject representative or member of a subject advocate group.”

On December 23, 2002, Thompson named 13 doctors, scientists, and other experts to SACGHS. The committee will be chaired by Edward McCabe, Executive Chair, Pediatrics Department, University of California, Los Angeles (UCLA) and Physician-in-Chief at UCLA’s Mattel Children’s Hospital. SACGHS’s charter has also been expanded to “more broadly consider the impact of genetic technologies on society.”

Social Behavioral Science Working Group

Meanwhile, the Social and Behavioral Science (SBS) Working Group, established by NHRPAC, is independently continuing its work of addressing the concerns of the social and behavioral science community regarding the human subjects protection system. (See Update, September 23, 2002). The group is continuing to deliberate the issues on its original agenda (e.g., student research, qualitative studies), developing and conducting a day-long course on human research protections in the social and behavioral sciences, and serving as a forum for dialogue and discussion with other key bodies (including the Association for the Accreditation of Human Research Protection Programs and the Federal Office of Human Research Protections).

November 4, 2002

CHARTERS OF DISSOLVED HHS ADVISORY COMMITTEES REVAMPED

On October 1, 2002, without public announcement, Secretary of Health and Human Services (HHS) Tommy Thompson signed the charter for a revamped human research protections advisory committee. In addition to being renamed, the Secretary’s Advisory Committee on Human Research Protections (SACHRP), formerly known as the National Human Research Protections Advisory Committee (NHRPAC), also had its charter expanded to include “human embryos” as human subjects. (See Update, September 23, 2002).

SACHRP’s charter specifies that the committee will provide advice relating to the responsible conduct of research involving human subjects with particular emphasis on:

Special populations, such as neonates and children, prisoners, and the decisionally impaired;
Pregnant women, embryos, and fetuses;
Individuals and populations in international studies;
Populations in which there are individually identifiable samples, data or information;
Investigator conflicts of interest.

The Charter also stipulates that SACHRP will be responsible for reviewing “selected ongoing work and planned activities” of the Office of Human Research Protections (OHRP) along with other entities within HHS responsible for human subjects protection.

The reconstituted Committee will consist of 11 members, including the chair. It will also have non-voting ex-officio members representing the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and others as deemed necessary by the Secretary. As with NHRPAC, the director of OHRP will serve as the Executive Secretary of the Committee.

Members shall be appointed to serve for overlapping terms of up to four years, subject to the renewal of the Committee charter. “Unless renewed by appropriate action prior to its expiration,” SACHRP will expire two years from the date the charter is filed.

Genetics, Health and Society Committee

On October 22, HHS announced the establishment of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). The new advisory committee replaces the Secretary’s Advisory Committee on Genetic Testing (SACGT).

The Advisory Committee is established to:

Provide a forum for expert discussion and deliberation and the formulation of advice and recommendations on the range of complex and sensitive medical, ethical, and social issues raised by new technological developments in human genetics;

Assist HHS and, at their request, other Federal agencies in exploring issues raised by the development and application of genetic technologies; and

Make recommendations to the Secretary of HHS concerning how such issues should be addressed.

The scope of SACGHS’s charge includes assessing how genetic technologies are being integrated into health care and public health; studying the clinical, ethical, legal, and societal implications of new medical applications, such as pre-implantation genetic diagnosis, and emerging technological approaches to clinical testing; identifying opportunities and gaps in research and data collection efforts; exploring the use of genetics in bioterrorism; examining current patent technologies; analyzing uses of genetic information in education, employment, insurance, including health, disability, long-term care, and life, and law, including family, immigration, and forensics; and serving as a public forum for discussion of emerging scientific, ethical, legal, and social issues raised by genetic technologies.

SACGHS will consist of 12 members selected by the Secretary or designee from individuals knowledgeable about molecular biology, human genetics, health care, public health, bioterrorism, ethics, forensics, law, psychology, social sciences, education, occupational health, insurance and other relevant fields. At least two of the members will be “specifically selected for their knowledge of consumer issues and concerns and the view and perspectives of the general public.” Unless renewed by “appropriate action prior to its expiration,” SACGHS will expire two years from the date of its establishment.

CONGRESS CONCERNED THAT SCIENTIFIC DECISIONMAKING IS BEING SUBVERTED BY IDEOLOGY

In a letter to Secretary of Health and Human Services (HHS) Tommy Thompson, a dozen Members of Congress, mostly Democrats led by Rep. Henry Waxman (D-CA), have expressed concern about “a pattern of events at [HHS] suggesting that scientific decision making is being subverted by ideology and that scientific information that does not fit the Administration’s political agenda is being suppressed.”

The Members explained that this concern arises as a result of “a series of troubling reports [that] have come out casting doubt on the Administration’s commitment to the tradition of scientific excellence and science-based decision making at HHS.”

Specifically, the Members note that “scientific information that does not serve the Administration’s ideological agenda is being removed from HHS websites. Expert appointments to scientific advisory boards are going to individuals with specific ideological viewpoints rather than scientific credentials.”

The signatories asked the Secretary to provide responses on six matters by October 30. These are:

1. All instances in which scientific information has been removed from any HHS website since January 2001 on the basis of a request from someone inside or outside the Department, the name of the requester, and the reason for the removal. If there was a scientific basis for the removal, please describe it in detail.

2. The name of each HHS advisory committee that has been terminated or has not been re-chartered since January 2001, with the basis for each termination or failure to re-charter.

3. The names and scientific qualifications of each expert who was recommended for the position of Chair of the Reproductive Health Drugs Advisory committee, from whom the recommendations were received, and the reason for the final selection if any.

4. The names of each HHS advisory committee on which the Administration has replaced, or plans to replace within the next year: (a) members whose terms have not expired, and the names of the members to be replaced; or (b) more than 2 members within a six-month period. In each case, to the extent known, provide the names and qualifications of the individuals who will replace the removed members, and if they were recommended by an industry group or other outside organization, from whom the recommendation was received.

5. HHS and CDC policies on audits, and a description of the controls in place to ensure that the process is not subject to political abuse.

6. The number of audits HHS or CDC have undertaken or planned of: (a) HIV/AIDS prevention education groups, (b) groups that oppose abstinence-only policies, and (c) abstinence-only programs.

The other congressional signatories on the letter to Thompson include: Reps. Sherrod Brown (D-OH), Nita Lowey (D-NY), Rosa DeLauro (D-CT), Diane Watson (D-CA), Bernard Sanders (I-VT), Edolphus Towns (D-NY), Carolyn Maloney (D-NY), William Lacy Clay (D-MO), Elijah Cummings (D-MD), Tom Allen (D-ME) and Dennis Kucinich (D-OH). As of November 4, Secretary Thompson had yet to respond to the letter.

September 23, 2002

HHS DISSOLVES HUMAN SUBJECTS PROTECTIONS COMMITTEE

Without explanation, the Department of Health and Human Services (HHS) has allowed the charters of at least two scientific advisory committees designed to provide guidance to Federal policy on the protection of human participants in research to expire. The committees, the National Human Research Protection Advisory Committee (NHRPAC) and the Secretary’s Advisory Committee on Genetic Testing (SAGGT), were chartered by President Clinton’s HHS Secretary Donna Shalala in June 2000 and June 1998, respectively. All of the committees’ deliberations, including a planned NHRPAC meeting in October, have been cancelled.

Administration officials have indicated that HHS is “diligently working” to reconstitute the panels, but they have not provided any public timetable for this action. Nevertheless, NHRPAC members are troubled that the Committee’s charter was allowed to expire.

"I am shocked and dismayed that NHRPAC has been permitted to lapse as a Federal Advisory Committee. It is a non-partisan body with its only intent the advancement of human research protection and the production of knowledge, including in the social and behavioral sciences, consonant with the best ethical practices. NHRPAC is a dedicated group that came together to address critical issues in human research protection system across fields of inquiry. To stop such progress in the making is sad indeed," observed NHRPAC’s Social and Behavioral Sciences Working Group Co-Chair Felice Levine.

Senators Edward Kennedy (D-MA) and Hillary Clinton (D-NY) sent a letter to Secretary Thompson expressing their “deep concern about reports that the administration is engaging in wholesale replacements of the experts on key scientific advisory committees. . . It is unimaginable, for example, that the public could be well served by the dismissal of the National Human Research Protections Advisory Committee after the tragic deaths of patients involved in clinical trials.” Kennedy and Clinton urged the Secretary to “reconsider these decisions.”

Theories regarding the reason for the dissolution abound. According to the September 17 edition of the Washington Post, many believe that HHS allowed NHRPAC, SAGGT, and possibly several other panels to disband as a result of the pressure the Administration was receiving from conservative groups that would like the advisory panels to pursue policies such as establishing rights as research subjects for the unborn.

While HHS has indicated that it feels that there is a need to broaden the purview of NHRPAC, the disbanded committee’s previous charter clearly stated that “NHRPAC will provide expert advice and recommendations to the Secretary of HHS, Assistant Secretary for Health (ASH), the Director, Office of Human Research Protections (OHRP), and other departmental officials on a broad range of issues and topics (emphasis added) pertaining to or associated with the protection of human research subjects.”

In the meantime, members of the committees are concerned that not only have their efforts been wasted, but there is now a void in the discussion of human participant protection in research.

NHRPAC’s Progress

Since its inception in 2000, NHRPAC has met on a quarterly basis, and its next meeting had been planned for October 2002. In addition, the Committee established several working groups to address a variety of issues, including: children, genetics, social and behavioral sciences, decisionally impaired, informed consent, and conflicts of interest. Most recently, the panel established a working group on prisoners and another to examine whether all disciplines should come under the Common Rule.

The Committee, chaired by Mary Faith Marshall, a Professor of Medicine and Bioethics at the University of Kansas Medical Center, operated in such a way that once it achieved consensus on an issue, its recommendations were posted on NHRPAC’s website (http://ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm) and transmitted to the appropriate HHS officials and agencies. A number of reports and documents, charting the progress being made, are posted on the Committee’s website, including:

Comment letter to HHS on 45 CFR 46 Subpart B – September 2001
Recommendations on HHS’s draft Interim Guidance on Financial Relationships in Clinical Research – October 2001
Clarification of the Status of Third Parties – Revised April 24, 2002
Comment Letter on HIPPA NPRM – April 2002
Report to NHRPAC from Social and Behavioral Science Workgroup on Public Use Data Files – April 2002
Draft work product from Genetics Workgroup – July 2002
Final Report to NHRPAC from Children’s Workgroup
Final Report to NHRPAC from Workgroup on Decisional Incapacity on Informed Consent and the Decisionally Impaired
Final NHRPAC Recommendations on Confidentiality and Research Data Protections, and Illustrative Overview of Federal Confidentiality Statues and Codes

SBS Working Group

What does this the dissolution of NHRPAC portend for the Social and Behavioral Science Working Group (SBS) co-chaired by Levine, Executive Director of the American Educational Research Association, and Jeffrey Cohen of OHRP? According to Levine, the group hopes to continue to address the numerous issues that were a part of its schedule and are associated with the protection of human research participants. “It would be a shame to lose such a formidable agenda,” Levine related.

Levine was appointed to NHRPAC by Shalala at the suggestion of COSSA and the social and behavioral science community. COSSA urged the expansion of the Committee to include a greater presence for social and behavioral scientists that have a different set of experiences and knowledge than biomedical researchers. Originally, the composition of NHRPAC included only one social scientist – Jennie Joe, University of Arizona, an anthropologist with public health and nursing training.

Other members of the SBS working group include: Christine Bachrach, National Institute of Child Health and Human Development; Richard Campbell, University of Illinois; Robert M. Hauser, University of Wisconsin-Madison; Robert Levine, Yale University School of Medicine; Sally T. Hillsman, American Sociological Association; Raynard Kington, National Institutes of Health Office of Behavioral and Social Sciences Research; Philip Rubin, National Science Foundation; Caroline Miner, U.S. Department of Justice; Jonathan D. Moreno, University of Virginia Health System; Ivor Pritchard, U.S. Department of Education; James Shelton, U.S. Agency for International Development; and Joan Sieber, California State University-Hayward.

The goals of the SBS working group were “to develop guidelines to help Institutional Review Boards (IRBs) review social and behavioral research involving human participants,” and to make “specific recommendations regarding additions or changes to the Common Rule relevant to the social and behavioral sciences.”

SBS completed several reports, two of which are posted on a website on the American Sociological Association’s homepage (http://www.asanet.org ): 1) Public Use Data Files and 2) Third Parties, both accepted by NHRPAC at its January, 2002 meeting. Final edits were underway on two statements, on confidentiality and risk and harm, for NHRPAC review and discussion. Other key issues marked for discussion by SBS focused on issues of scientific substance, the human subjects protection system, and researchers. They included:

Identification of risk (type and levels) in the social and behavioral sciences
Relationship between risk, methods, substance of study, and subject populations
Consent and written consent (timing and amount of disclosure)
IRBs and their readiness to review social and behavioral research
Knowledge of social and behavioral science research
Composition of IRBs and other issues relating to expertise
Knowledge and educational needs regarding ethical practices
Educational needs relating to the Common Rule and role of IRBs

Reports planned for the future included addressing several new areas: informed consent, international research, classroom research, observations in public places and field research, and ethnographic and qualitative research.

In addition to the reports, the SBS Working Group members have given presentations at the various scientific societies’ annual meetings and have held special sessions with department chairs at others.

April 29, 2002

CONGRESS EXAMINES RESEARCH PROTECTION OVERSIGHT SYSTEM: LEGISLATION NEEDED

Examination of the Federal government’s oversight system for protecting human research participants continued on April 23rd as the Senate Health, Education, Labor and Pensions Subcommittee on Public Health held a hearing analyzing the issues surrounding protecting participants in research, including appraising the remaining gaps in the oversight system. The Subcommittee also considered the need for legislation to address the issue.

Senator Edward Kennedy (D-MA), the Subcommittee’s Chairman, observed that a number of reports (including those issued by the National Bioethics Advisory Commission (NBAC) and the Department of Health and Human Services’ (HHS) Office of the Inspector General) have identified “serious flaws” in the oversight of the human research system “that must be corrected.” Noting the Committee’s long-standing interest in this issue, he emphasized that correcting those flaws is an “urgent task.”

According to Kennedy, legislation is necessary to accomplish this. He is currently drafting a bill that would, among other things, require all institutions to be accredited in order to conduct research involving human participants. Kennedy’s legislation would retain the existing oversight framework and grant greater statutory authority to the HHS’s Office of Human Research Protections (OHRP).

Ranking Minority member Bill Frist (R-TN), a heart-transplant surgeon and clinical researcher, echoed the Chairman’s call for legislation to provide greater safeguards for research participants. “Unfortunately, recent, highly-publicized tragedies have shaken the public’s trust and confidence,” he explained. Frist, who convened two hearings in the 106^th Congress on this issue while he was Chair of the Subcommittee, related that it became “clear that there had been a systematic breakdown of oversight ranging from the investigators to the institutional review boards (IRBs) to the federal agencies responsible for ensuring the safety of patients.”

Meanwhile, on the House side, Reps. Dianna DeGette (D-CO) and Jim Greenwood (R-PA), both members of the House Energy and Commerce Committee, are drafting a measure that would also work within the existing oversight framework and grant greater authority to the OHRP. Their bill would also require prior written consent for all research. As currently drafted, however, it is unclear whether the bill would allow exceptions to this requirement.

The Senate hearing’s witnesses, a quartet of academic and corporate representatives, included Marjorie Speers, Executive Director of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and former Acting Executive Director of NBAC.

Testifying in this latter capacity, Speers noted that great strides have been made in human participants research in many fields, including the social sciences, the humanities, and the biomedical sciences. She recognized that “NBAC was not alone in its deliberations on the human research system,” noting the work of the Institute of Medicine, the U.S. General Accounting Office, the Office of the Inspector General at HHS, and others.

Speers focused her remarks on three of the 30 recommendations made by NBAC to change the oversight system at the national and local levels that would ensure all research participants receive appropriate protections and remove unnecessary burdens. (See Update, June 4, 2001).

NBAC’s recommendations called for the independent review of risks and potential benefits of voluntary informed consent for participants in both publicly and privately sponsored research. This recommendation is vitally important, Speers stressed, because it responds to concerns about research conducted by Federal agencies that do not follow the Common Rule or privately funded research that is not regulated by the Food and Drug Administration.

She underscored the NBAC’s support for legislation that would create a “single, independent Federal office to lead and to coordinate the oversight system” outside of HHS, but noted that this is not meant as a criticism of OHRP; rather, NBAC recognizes the need for a Federal office to exist independently and outside of any department or agency that sponsors research and be responsive to the ethical issues of all fields of research, not just those of primary concern to the HHS.

The Commission’s support for a “unified, comprehensive Federal policy embodied in a single set of regulations and guidance” that would apply to all types of research involving human participants was the third recommendation highlighted. A wide variety of research, from clinical trials to social science methods, is currently regulated under the same set of Federal rules. Speers emphasized that the rules “were originally written by the National Institutes of Health and do not always appropriately address the ethical issues in research outside of the biomedical context.”

‘Voluntary Self-Regulation’

Also testifying in her capacity as the Executive Director of AAHRPP, Speers called for a voluntary accreditation system. She explained that while the NBAC took a stand in favor of accreditation, AAHRPP believes that “voluntary self-regulation by the research community, along with oversight by an independent accrediting body, is the best strategy for making research as safe as it possibly can be.” AAHRPP, emphasized Speers, has taken governmental policy and developed it (with input from a diverse range of professionals and the public) into a clear set of accreditation standards. Those standards meet all regulatory requirements and, in some cases, exceed them, she declared.

Opposing a voluntary accreditation program, Cherlynn Mathias, a whistleblower of research conducted at the University of Oklahoma and the panel’s first witness, pressed the case for mandatory accreditation. Based on her experience, Mathias explained that she believed that voluntary accreditation would not be adequate.

Speers stressed that AAHRPP’s standards are significant in several other respects: they are broad and flexible so that they will be meaningful to a full range of research types; certainly in clinical research, but also in social science, historical, and business research. They can be applied in a variety of research settings, including universities, hospitals, government agencies, and independent IRBs.

According to Speers, the standards also make clear that protecting research participants is not the sole responsibility of IRBs, but a duty shared by everyone who conducts research. "By requiring institutions to meet an explicit set of standards for protection, AAHRPP's goals are to recognize institutions that meet these high standards. We believe this voluntary self-regulation by the research community, along with oversight by an independent accrediting body, is the best strategy for making research as safe as it possibly can be," Speers concluded.

AAHRPP was founded by seven diverse organizations, including COSSA. (See Update, June 4, 2001). For additional background on issues related to human subjects protection, see the COSSA webpage at www.cossa.org/hsbackground.htm.

February 11, 2002

RESEARCH PROTECTION COMMITTEE ACTS ON SOCIAL SCIENCE ISSUES

The National Human Research Protection Advisory Committee (NHRPAC) took significant action on issues important to the social sciences at its meeting last month. It also heard from social scientists and humanists who presented their views on the human research protection system, as well as the administration’s chief scientist.

The panel examined a number of recommendations from its Social Science Working Group (SSWG), co-chaired by American Sociological Association Executive Officer Felice Levine. One issue that NHRPAC appeared to settle was how to treat Public Use Data Files. It approved guidelines that make clear to Institutional Review Boards (IRBs) that public use data files should be subject to review, and certified as such, before they are made publicly available. However, once they are certified, IRBs should not require other investigators to seek review when using them.

NHRPAC also agreed to recommendations regarding Third Parties – persons referenced by human subjects in the course of their interaction with investigators. Are these persons human subjects and thus subject to the rules of protection? The agreed-to statement says that IRBs should determine that third parties are human subjects if they can be identified, and if the IRB concludes that the focus of the research is really on the third party and not only on the originally designated human subject. Such a determination would require the investigator to provide the third party with consent options.

Both of these NHRPAC recommendations are made to the Secretary of Health and Human Services and the Director of the Office of Human Protections for their consideration and implementation.

NHRPAC also discussed two other issues that emanated from the SSWG.

The committee accepted the notion that in defining “minimal risk,” the probability of harm and the magnitude of harm should be treated as separate concepts. It also will clarify the “daily life” standard used to define risk in the Common Rule currently governing human subjects protection. NHRPAC will now seek final language on this issue for review and approval at its next meeting.

Finally, NHRPAC accepted, in principle, a report and recommendations from the SSWG regarding confidentiality. One recommendation is that IRBs should recognize that when identifiable data are shared between investigators, the original confidentiality protections are transferred with the data.

For more information about the recommend-ations on all four of these issues, go to http://ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm and www.asanet.org/public/humanresearch.

History, Journalism, Ethnography as Special Cases

The advisory committee also heard from Linda Shopes of the Pennsylvania Historical and Museum Commission, Margaret Blanchard, Professor of Journalism and Mass Communication at the University of North Carolina, Chapel Hill, and Jonathan Church, Chair of Sociology and Anthropology at Arcadia University in Pennsylvania.

Shopes presented the case for oral historians who believe IRBs do not understand their research methods. Some IRBs, Shopes reported, have asked oral historians to provide advanced questionnaires, to destroy interview tapes, and to protect anonymity of respondents. She declared that these are constraints on historical inquiry, and argued that oral historians should be exempt from the human subjects protection system because their research is of minimal risk and does not produce “generalizable knowledge.”

Blanchard confronted the issue of whether subjecting journalism research to IRB review is not an example of prior restraint and thus a violation of the free press clause of the First Amendment. She also argued for an exclusion from the human subjects protection system as practiced by IRBs.

Church declared that IRBs are having a “chilling effect” on the ability of ethnographers to conduct research. He claimed that IRBs do not understand that requiring prior “informed consent” is “inherently problematic” for ethnographic research techniques where consent occurs as part of the constant activities of doing the research.

He argued that social/behavioral scientists should become more involved in the IRB process, especially at small schools where biological problems dominate the human subjects protection system.

The reaction of NHRPAC members to these presentations varied. The greatest support came for the notion that the First Amendment did offer protections for journalism professors; however, they envisioned situations where oral historians and ethnographers could place their research subjects at risk, and therefore suggested that some sort of review is necessary.

The President's Science Adviser

John Marburger, Director of the White House Office of Science and Technology, addressed the panel, emphasizing the President’s commitment to taking ethical responsibilities seriously and his “strong moral positions.”

“Science tells us what we can do, not what we should do,” Marburger asserted. Thus, despite extraordinary scientific advances leading to the rapid evolution of new knowledge, he urged, the moral and ethical implications of these advances must be considered.

The goal of human subjects protection, he concluded, is to achieve uniformity and effectiveness without inhibiting research. The system should be flexible, with “responsible regulations” at both extremes of risk. He also stressed the importance of confidentiality for social surveys and psychological issues.

Finally, NHRPAC also heard from Alan Milstein, an attorney representing a number of clients in lawsuits against universities. In their remarks to the committee, both Milstein and one of his clients, Paul Gelsinger, father of Jesse Gelsinger, who died in a University of Pennsylvania clinical trial, seemed most concerned about financial conflict of interest issues. Karen Rothenberg, Dean of the University of Maryland Law School, responded to Milstein’s assertions about the applicability of Tort Law to these situations.

January 24, 2002

PRESIDENT’S COUNCIL ON BIOETHICS NAMED, HOLDS FIRST MEETING

In unveiling his stem cell decision last August, President Bush announced the creation of a President’s Council on Bioethics, to be chaired by University of Chicago bioethicist Leon Kass. Two weeks ago, the panel began work in earnest, as the White House named 17 members to the body and the Council convened its first meeting in Washington.

Several prominent social scientists are among the appointed members (see list below). Carter, Dresser, George, and Glendon are all legal scholars, Fukuyama is a professor of international political economy, and Sandel teaches contemporary political philosophy and the history of political thought. Wilson, a UCLA professor of Management and Public Policy emeritus, is also a former president of the American Political Science Association.

At the first meeting, Kass laid out his vision for the Council, saying that he expected it “to provide an adequate moral and ethical lens through which to view particular [technological] developments in their proper scope and depth.” President Bush – in his Executive Order creating the Council – also directed the panel to “be guided by the need to articulate fully the complex and often competing moral positions on any given issue, rather than by an overriding concern to find consensus.”

Cloning, discussion of which began at the meeting, will be the body’s short-term focus, but it may eventually turn its attention to issues of more direct concern to social scientists. The Bush Executive Order named the protection of human subjects in research as a potential area of Council study. The panel’s agenda picks up on the mission of the recently expired National Bioethics Advisory Council, an entity appointed by President Clinton which issued its final report in September (see Update, September 24, 2001).

Full biographies on the appointees and the Executive Order creating the Council are available on the White House website, www.whitehouse.gov.

The President’s Council on Bioethics

Leon Kass, University of Chicago, Chairman

Elizabeth Blackburn, University of California, San Francisco

Stephen Carter, Yale Law School

Rebecca Dresser, Washington University School of Law

Daniel Foster, University of Texas Southwestern Medical School

Francis Fukuyama, Johns Hopkins University

Michael Gazzaniga, Dartmouth College, Director of fMRI Center for Brain Research (an NSF SBE infrastructure project)

Robert P. George, Princeton University

Alfonso Gomez-Lobo, Georgetown University

Mary Ann Glendon, Harvard University

William B. Hurlbut, Stanford University

Charles Krauthammer, The Washington Post

William F. May, Southern Methodist University

Paul McHugh, Johns Hopkins University School of Medicine

Gilbert Meilaender, Valparaiso University

Janet D. Rowley, University of Chicago

Michael J. Sandel, Harvard University

James Q. Wilson, University of California, Los Angeles

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Sep. 24, 2001

NATIONAL BIOETHICS ADVISORY COMMISSION ISSUES FINAL REPORT

The National Bioethics Advisory Commission (NBAC) issued its final report, Ethical and Policy Issues in Research Involving Human Participants on September 12. NBAC, established by Executive Order in 1995 by President Clinton and chaired by former Princeton University President Harold T. Shapiro, will be replaced by a new President’s Council on Bioethics, chaired by Leon Kass, professor and biomedical ethics expert at the University of Chicago. NBAC’s charter expires on October 3, 2001. A September 19 meeting by the Commission to discuss outstanding issues was cancelled and has not been rescheduled.

A key conclusion of the Commission’s report, observed Acting Executive Director of NBAC Marjorie Speers, is that the federal oversight system should protect the rights and welfare of human research participants regardless of whether the research is publicly or privately sponsored. NBAC has repeated this assertion throughout its deliberations, and recommendations in this regard appear in its four previous reports.

To accomplish this goal, NBAC recommends a “unified, comprehensive federal policy embodied in a single set of regulations and guidance.” Any central coordinating body, argues the Commission, should be open to public input, have significant political or legal authority over research involving human participants and have the support of the executive and legislative branches of government. Currently no federal entity has the authority to develop policy for all research involving human participants. Consequently, the Commission calls for legislation creating a single, independent federal office.

NBAC acknowledges that adoption of its recommendations will generate additional costs for all involved in research, but urges sponsors of research, whether public or private, to work together with institutions carrying out the research to make the necessary funds available.

Additional Ethics Research Needed

NBAC also recognizes that its report raises many questions about ethical issues that cannot be answered because of insufficient or nonexistent empirical evidence. “Current thinking about ethical issues in research – such as analysis of risks and potential benefits, informed consent, privacy and confidentiality, and vulnerability – would greatly benefit from additional research.” Accordingly, the Commission recommends that the federal government (along with academic institutions and professional societies) “should facilitate discussion about emerging research protection issues and develop a research agenda that addresses issues related to research ethics.”

Ethical and Policy Issues is the result of a review of the current system for the protection of human participants in research. Through a series of meetings held throughout the United States, the Commission examined the effectiveness of the oversight system, with particular attention to the “Common Rule.” In addition, the Commission investigated the purpose and structure of the oversight system, ethical issues in the review of research, and the role of research sponsors, investigators, institutions, and Institutional Review Boards.

Copies of the report and the accompanying commissioned papers can be downloaded or requested via the NBAC website: www.bioethics. gov.

President’s Council on Bioethics

According to President Bush, the new President’s Council on Bioethics responsibilities “will include studying the human and moral ramifications of developments in biomedical and behavioral science and technology.” In addition, the Council will explore such issues as embryo and stem cell research, assisted reproduction, cloning, genetic screening, gene therapy, euthanasia, psychoactive drugs, and brain implants, says the President. A time frame for appointing the Council’s members has not been established.

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Sep. 10, 2001

IOM EXAMINES IRB SYSTEM

On August 21 - 22, the Institute of Medicine (IOM) Committee on Assessing the System for Protecting Human Research Participants, one of four entities looking at the issue of human participant protections in research, held its fifth meeting to examine the structure, function, and performance of human subject protection activities with a focus on clinical and biomedical research (see Update, January 29, 2001). Daniel Federman is the Committee’s Chair. The meeting examined IRB (Institutional Review Board) administration and operations.

The IRB process is a system overwhelmed, declared Tom Puglisi, invited by the Committee to discuss IRB administration. Puglisi, from Pricewaterhouse-Coopers, is the former director of the Human Subject Protections in OHRP (formerly the Office of Protections from Research Risks). He outlined major challenges to the IRB system.

The IRB system is marked by increased volume, complexity, and expectations coupled with insufficient resources and expertise, said Puglisi. It is being supported by volunteers who are doing work on their own time, out of their own generosity, and with no systematic training.

Citing several medical studies that have received negative attention, he emphasized that the attention paid to these studies make people believe that research is unsafe and unregulated and that volunteers are guinea pigs.

Echoing the National Bioethics Advisory Commission (NBAC) recommendation that all research, both privately and federally funded, be subjected to IRB review, Puglisi called for universal coverage of all research. He also endorsed NBAC’s call for a single federal agency to enforce that requirement and the establishment of data safety monitoring boards (DSMBs).

There is also a need to think about how IRBs conduct their oversight. The present system, said Puglisi, is “labor and paper intensive but not very effective. IRBs spend too much time doing the wrong thing and not asking the right questions,” he noted.

Puglisi called for a clarification of the definition of research, as well as what is not considered research but should be subject to review. He also called for a better definition of “minimal risk,” specifically in a social science context. Noting that the level of review should correspond to the level of risk, Puglisi advocated a rapid, non-labor intensive review of all minimal risk research. “Social science research can be risky, horrendous, and morally objectionable, but all of it does not need the kind of review that it is currently undergoing,” said Puglisi.

Human subject protection is the cost of doing business, said Puglisi, echoing other entities reviewing human participant protection. He called for an increase in resources dedicated to human research participant protection by government, industry, and research institutions. He also recommended resources be dedicated to the ongoing education of IRB members and the research community, and to an increase in the number of IRB members and to better documentation of the IRB process.

Finally, Puglisi called for more public education about research and the attendant risks and benefits, and endorsed the need for more public participants on IRBs.

Crisis of Confidence

Robert Levine of Yale University, a member of the National Human Research Protection Advisory Committee, echoing Puglisi, asserted there is a crisis of confidence surrounding the human subjects protection system. The most significant consequence, Levine declared, is the loss of motivation by researchers to serve as IRB members.

Levine observed that while IRBs have been doing well over the years, they are presently overburdened. The current public perception of IRBs is that, in addition to being overburdened, they are incompetent and primarily concerned with protecting the institution and promoting self-interest. Levine recommended that IRB members focus on important matters that match their skills; he also called for accreditation of IRBs.

He concluded that “in this season of rapid change in national leadership and policy, there is an opportunity to reevaluate and revise policies and practices regarding human subject protection.” He recommended that the IOM committee reevaluate and restate charges to IRBs.

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Aug. 13, 2001

MARJORIE SPEERS NAMED EXECUTIVE DIRECTOR OF AAHRPP

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has announced the appointment of Marjorie Speers as its new executive director. Speers currently serves as the acting executive director at the National Bioethics Advisory Commission (NBAC), on detail from the Centers for Disease Control and Prevention (CDC). She will begin her new position at AAHRPP in Rockville, Md., on October 1.

Speers joined NBAC in 1999 as project director for a comprehensive report on human subjects protection in the United States. (For information about the report see UPDATE ) From 1995-2000, she was deputy associate director for science at the CDC in Atlanta, where she oversaw all domestic and international research. In addition, she served as CDC’s Behavioral and Social Science Coordinator. From 1991-1995 she served as director of the Division of Chronic Disease Control and Community Intervention at CDC. COSSA worked closely with her on adding social and behavioral concerns to the CDC’s agenda and she has briefed the COSSA Executive Committee on NBAC’s activities. She has taught at the University of Connecticut and the University of Texas Medical Branch. Her Ph.D. is in psychology and epidemiology from Yale, her B.A. is from Dickinson College.

AAHRPP, a new national accrediting entity formally announced in May, is developing a voluntary, peer-driven, educationally focused accreditation program for human research protection, using a site visit model that employs a rigorous set of performance standards and outcome measures. AHRPP's founding member organizations are the Association of American Medical Colleges, Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Association of State Universities and Land-Grant Colleges, National Health Council, and Public Responsibility in Medicine and Research. Representatives from each organization served on the search committee for the executive director.

AAHRPP has already commissioned a new set of draft accreditation standards, which are under revision and will be released in September for public review and comment. These standards have been prepared to conform to the recommendations of the April report from the Institute of Medicine, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. AAHRPP has contracted to conduct one pilot site visit, and additional visits to public and private research entities will be completed this fall. Informed by the results of the pilot site visits and comments received on the draft standards, accreditation visits will begin in earnest in early 2002.

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Aug. 13, 2001

HUMAN SUBJECTS ADVISORY GROUP MAKES RECOMMENDATIONS

The interest and activity surrounding the protection of human research participants intensified with the recent suspension of all federally supported medical research involving human participants at Johns Hopkins University by the Office of Human Research Protection (OHRP) in July.

At the July 30-31 meeting of the National Human Research Protections Advisory Committee (NHRPAC), the advisory body to the Office of Human Research Protections, the Social and Behavioral Science Working Group updated the committee on its efforts. Felice Levine (Executive Officer of the American Sociological Association and member of the COSSA Executive Committee) and Jeffrey Cohen (Director of OHRP’s Division of Education) co-chair the workgroup.

The group was created in an effort by NHRPAC to reach out further to the social and behavioral science community. At its inaugural meeting in December, 2000, the committee agreed to issue a formal request for guidance on how to approach issues particular to nonbiomedical research (see Update, January 15, 2001).

Levine informed NHRPAC that while its efforts are clearly a work in progress, the group has made significant advancement on the objectives it outlined to NHRPAC in April. The group, she explained, focused much of its attention on three areas of the human subjects protection system as it relates to the social and behavioral sciences: public use data files, risk and harm, and third parties. The group now invites the input of NHRPAC and the wider community as it continues “to further revise and refine the ultimate guidance that the group provides to NHRPAC.”

The group has also begun to examine other areas of human participant protection. Those include informed consent, privacy and confidentiality, and exemptions and expedited review. The group anticipates submitting draft recommendations on these topics at NHRPAC’s October meeting.

Public Use Data Files

A great deal of social science research involves secondary analysis of survey data files intended for public use. “There is a fair amount of confusion in both the social science and human subjects regulatory communities,” Levine observed, “about the analyses of data from public use files and what requires IRB review.” The group’s recommendations are intended to provide guidance to IRBs and also to OHRP and the research community about public use data files and the protection of human participants, she emphasized.

1. OHRP should clarify that a “public use data file” is not data from human participants and thus not under the purview of IRBs. Investigators should be free to use public use data files without prior review, permission, or notification.

2. OHRP should clarify that there is no need to classify research using existing data as exempt because in reality it is not research involving human participants, either because the existing information is otherwise publicly available or because private information is not readily identifiable under the definition of human participants.

3. The responsibility for demonstrating that data in a public data file does not permit identification of participants should be vested in the supplier of the data rather than in the user.

4. OHRP should develop a mechanism by which certain organizations can certify data files as de-identified if the production of public use data files was not previously reviewed.

5. OHRP should advise IRBs that investigators in the social and behavioral sciences are encouraged to make public use data files accessible to secondary users in order to maximize the benefit of human participants providing information and to minimize the burden on new pools of human participants.

6. OHRP should advise IRBs on human participants review procedures for research analyzing existing data that are not public use files. If an investigator plans to use extant data under conditions already specified by an IRB or other established procedures, then there should be no additional review by an IRB.

7. Investigators seeking to merge public data files or enhance a public data file with identifiable data should obtain IRB review and approval.

8. A web-based training module on confidentiality issues involved in the preparation and analysis of public data files should be developed.

Risk and Harm

The group addressed the social and behavioral science community’s concerns that the definition of minimal risk as set forth in the Common Rule may not be sufficiently understood in practice by IRBs and researchers.

1. OHRP should issue guidance to IRBs, the research community, and others associated with the human participant protection system regarding the definition of minimal risk.

2. OHRP should clarify that much of the research in the social and behavioral sciences involve minimal risk; that is, that the potential harm and its likelihood of occurrence are no more than would be encountered in daily life or during the performance of routine medical tests or psychological examinations.

3. OHRP should emphasize the “daily life” standard for minimal risk. Guidance should also make clear that the “daily life” standard refers to low-level harms which are transient in nature and easily ameliorated either by passage of time, adequate debriefing, or both.

4. OHRP should clarify that, in much social and behavioral science research, the most serious harm that could occur to participants would result from breach of confidentiality. Thus, OHRP should emphasize to IRBs the importance of research protocols addressing how information from human participants will be protected.

Third Parties

In January, 2000, the Office of Protection from Research Risks issued a ruling in a compliance case that, although not intended as policy, created confusion among IRBs, investigators, and funding agencies. The case involved the definition of human subjects and whether information collected about third parties should require their informed consent. The group’s recommendations address the situation of third parties in research (e.g., individuals who do not actually participate in research but become associated with research through information about them provided by human participants).

While NHRPAC has also formed a specialized Working Group on Third Parties, the NHRPAC Social and Behavioral Science Working Group is providing independent input on the issue. Levine serves as a consultant to the Third Party Working Group and has informed that group of the activity and interest of the Social and Behavioral Science Group on these issues.

The Social and Behavioral Science Working Group considers third parties not to be human subjects, but believes efforts should be directed towards ensuring the highest standards for the protection of all data on both human subjects and third parties.

Accordingly, the group’s recommendations concerning third parties in research focus on the importance of protecting the privacy of these parties and the confidentiality of the information obtained at all stages of the research, through publication and the creation of any public use data files. The group believes that emphasis should be placed on privacy and data protection rather than on broadening the definition of “human subject” to include third parties or developing a framework to allow for consent (or waiver of consent) by these individuals.

1. Absent a change in the Federal Regulations, OHRP should issue guidance to IRBs that other persons referenced by human subjects in the course of research should not be considered human participants in that research.

2. OHRP should clarify that identifiable private information in the context of the Federal Regulations should be understood as not only private information provided by human participants about themselves but also private information provided by human participants that is both relevant to them and about any other identifiable individuals.

3. OHRP should clarify that the capacity to consent to participate in research should belong to the actual individuals who are deciding whether to participate, not with those about whom human participants might provide identifiable private information. The requirement to obtain informed consent should not apply to third parties. Such consent could be in conflict with the consent provided by human participants by revealing, even implicitly, the identities of those participants or by jeopardizing them through revealing that they had provided certain information.

Next Steps

Levine informed NHRPAC that in August the Working Group will convene at the annual meetings of social and behavioral science organizations. They have also made contact with the new National Academy of Science panel launched by the Commission on National Statistics (see Update, July 22, 2001).

Based on the feedback from those meetings, the Working Group will submit final recommendations to NHRPAC for consideration at its next meeting in October. To review and/or submit comments on the group’s recommendations, go to www.asanet.org.

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July 2, 2001

HUMAN SUBJECTS: FOCUS ON SOCIAL AND BEHAVIORAL SCIENCE

On June 28 and 29, the Panel on Institutional Review Boards, Surveys, and Social Science Research held its first meeting commencing an 18-month study by the Committee on National Statistics (CNSTAT), in collaboration with the Board on Behavioral, Cognitive, and Sensory Sciences and coordinating with the Institute of Medicine (IOM). Cora Marrett, former Assistant Director for the Social, Behavioral, and Economic Sciences at the National Science Foundation, is the panel’s chair. Marrett is currently in transition from the Vice-Chancellor of Academic Affairs and Provost at the University of Massachusetts-Amherst (until August 1) before moving on to become the President of the University of Wisconsin system.

The Panel on Institutional Review Boards, Surveys, and Social Science Research will review current and proposed methods of human subjects protection in social science data collection. A focus will be on the structure, function, and performance of the Institutional Review Board (IRB) system designed by the Department of Health and Human Services “largely to guide clinical and biomedical research but that also affects social science researchers.”

This study will complement the IOM study, Assessing the System for the Protection of Human Research Subjects, that is examining the structure, function, and performance of human subjects protection activities with a focus on clinical and biomedical research (see Update, January 29, 2001). Although the CNSTAT study will inform the IOM study, its findings will also be published in an independent report. The report will provide recommendations to assure the protection of human participants in social science research that can accommodate differences between social/behavioral and clinical/biomedical research.

In a letter to Marrett, Daniel Federman, chair of the IOM study, noted that “to ensure that research is getting a fair and technically informed review is an issue regardless of whether oversight is linked to accreditation, federal regulation, or any other mechanism. . . How best to oversee IRBs that review mainly or exclusively survey and population studies is an issue that we hope you can take up, as well as how to ensure sound review at institutions (or IRBs within them) that review mainly clinical or other research, but occasionally encounter social, behavioral, and population research protocols.”

Marrett acknowledged that within the limited time period given for the study, the panel needs to ensure that it is having the best kind of impact. She invited panel members and the social and behavioral science community to share, in addition to their comments on what issues and topics should be discussed by the panel, what should not be on the agenda.

Assessing the System

Roderick Little, professor of Biostatistics at the University of Michigan and a member of the IOM study and CNSTAT, noted that phase I of the IOM’s two-phase study “cautiously accredited accreditation.” The IOM panel, he observed, is aware of the sensitivity of the social and behavioral science community. That panel, he said, does not have the breadth and knowledge needed to do justice to behavioral and social science research. The prospect for collaboration is excellent for the two panels, said Little. The CNSTAT panel is an “extremely important venture.”

Jeffrey Cohen, director of the Office of Human Research Protection’s (OHRP) division of Education and Development, observed that there are currently three other groups in addition to the CNSTAT panel addressing the issues of the social and behavioral sciences.

The first is the National Human Research Protection Advisory Council (NHRPAC) to OHRP that has a Social and Behavioral Science Working Group, co-chaired by Cohen and Felice J. Levine, Executive Officer of the American Sociological Association. This workgroup has two core goals: “to develop guidelines to help IRBs more effectively administer the human subjects protection system, and to make specific recommendations regarding additions or changes to the Common Rule with respect to the social and behavioral sciences.”

The second group looking at this issue is the Human Subjects Research Subcommittee of the Committee on Science at the National Science and Technology Council, chaired by OHRP Director Greg Koski. It is the interagency committee for those 17 federal agencies that are involved in the Common Rule.

The third is the National Science Foundation’s Advisory Committee for Social, Behavioral and Economic Sciences (SBE) Subcommittee for Human Subjects. According Norman Bradburn, Assistant Director of the SBE, NSF is circulating an agenda to explicate the differences between behavioral and social science and the medical model. Bradburn stated that NSF would like to end up with a set of specific guidelines for interpreting specific cases, stressing the flexibility of IRBs.

Cohen emphasized that OHRP does not want four separate sets of recommendations. Director Koski has said he wants to make a concerted effort to come up with a single set of recommendations.

Cohen announced that there was still room at a workshop being sponsored by OHRP and the University of Southern California, July 16-17, on “Informed Consent, Cultural Values, and Regulatory Overview: A Closer Look at Behavioral Issues in Biomedical and Social Science Research.” OHRP, he said, plans to continue doing workshops and outreach to the behavioral and social science community. For more information see www.usc.edu/dept/law/Pacific_Center/workshop.

It is OHRP’s position that the Common Rule provides sufficient flexibility for the oversight of behavioral and social science research. Cohen said, however, that more guidance is needed for IRBs and researchers. Accordingly, OHRP is developing guidance for the social and behavioral sciences, including the creation of a new set of decision charts. The Office is seeking the input of the behavioral and social science community before posting them on the agency’s website. For more information see http://ohrp.osophs.dhhs.gov/.

Look Beyond the IRBs

Belinda Seto, Deputy Director of the National Institutes of Health’s Office of Extramural Research, observed that NIH has large investments in behavioral and social science research. She urged, as she had the IOM panel, that the CNSTAT panel broaden its focus beyond the IRBs. While IRBs are a critical part of the system to protect human subjects, there are other components, Seto emphasized.

The education of investigators is also important, Seto said. There is a need for the elevation of general knowledge of human subjects research. She informed the panel that beginning October 1, NIH will require investigators to document that they have taken a course in human subjects protection. NIH will leave it to the researcher to decide how to fulfill this requirement.

A second component of the human subjects protection system, said Seto, is data and safety monitoring boards (DSMBs), which play an important role in protecting human subjects. An independent evaluation of DSMBs is important for the behavioral and social sciences.

A third component is how to protect the rights and interests of third parties about whom investigators learn private information during the course of doing research. Under the current regulatory interpretation, these individuals become human subjects. The NIH, working with OHRP, has created a working group that is drafting guidance to address this issue, Seto said.

NIH would also like the CNSTAT panel to consider the area of data protection – to the extent that one can require an investigator to be sensitive to data issues. Finally, Seto urged consideration of conflict of interest issues for investigators, institutions, and IRBs.

Professional Associations

The panel also heard from professional associations, including COSSA members.

Rob Hauck, Deputy Director of the American Political Science Association, told the panel that it is “important to distinguish between the provisions of the Common Rule and the selective interpretation of the Common Rule by Institutional Review Boards.” The confusing and often contradictory application of the Common Rule by local IRBs undermines its flexibility, said Hauck.

He emphasized that over time, institutions have unilaterally expanded the scope of IRB oversight to include all research involving human participants regardless of sources of funding, extended the review requirement to previously exempted research, favored full over expedited review, and abandoned the differentiated assessment of risk in favor of standardized consent requirements.

Hauck cited as an example two political scientists from major research universities on the west coast who underwent a nine-month IRB review although their project involved nothing more than asking participants to guess the outcome of a coin toss.

In practice IRBs are reluctant to alter or waive the active consent requirement even though it may be inappropriate to the research method or setting. For political science research conducted abroad, the written requirement may be at odds with cultural and social norms, he explained.

Mary Margaret Overbey, Director for Government Affairs at the American Anthropological Association, explained to the panel that anthropology involves four subfields: archaeology, cultural anthropology, biological or physical anthropology, and linguistic anthropology. Most anthropological research, said Overbey, is generally low-risk.

What we need is massive education at all levels of the research process, said Merry Bullock, Associate Director for Science, American Psychological Association. Some behavioral research is very similar to prototypical clinical/ biomedical research; other behavioral research is closer to prototypical social science research. Very little attention is paid to the difference. The regulations are very general and can be applied quite flexibly, said Bullock.

According to Bullock, challenges include:

· Providing adequate guidance – guidance is inadequate in such areas as risk-benefit analysis (e.g., identification of potential harm, determination of probability of that harm, and determination whether adequate steps taken to minimize that harm)

· Increasing IRB expertise – there is a lack of content knowledge which hinders realistic risk assessment, leading to rigid and conservative interpretation of regulations

· Reducing researcher naiveté – researchers often lack knowledge about regulations, how the regulations apply to their research, and about IRB processes and what information is relevant in a protocol

Potential solutions, said Bullock, include: the education of researchers regarding regulations and their applicability, guidance for IRBs (especially on risk assessment and informed consent) and more involvement of behavioral and social science researchers in IRBs.

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Jun. 4, 2001

NBAC CALLS FOR A SINGLE FEDERAL POLICY TO PROTECT HUMAN RESEARCH PARTICIPANTS

In its key conclusion that the federal oversight system should protect the rights and welfare of human research participants, regardless of whether the research is publicly or privately sponsored, the National Bioethics Advisory Commission (NBAC) recommended that there be a unified, comprehensive federal policy embodied in a single set of regulations and guidance. The Commission further highlighted the fact that there is not a single federal entity with the authority to develop federal policy for all research involving human participants.

Accordingly, the Commission’s recently released recommendations call for legislation creating a single, independent federal office, the National Office for Human Research Oversight (NORHO), to lead and coordinate the research oversight system. “This office should be responsible for policy development, regulatory reform, research review and monitoring, research ethics education, and enforcement.”

In a year-long discussion of research oversight issues, the Commission examined the effectiveness of the oversight system, paying particular attention to the “Common Rule,” a set of regulations followed by 17 agencies of the federal government.

NBAC released its recommendations during its 48^th meeting on May 15, 2001. The recommendations, available on the Commission’s website (www.bioethics.gov), will be incorporated into the Commission’s upcoming report, Ethical and Policy Issues in Research Involving Human Participants. The report, requested by the White House in October, 1999, is expected to be available later this summer.

In addition to changes at the national level, NBAC’s recommendations also address:

·the review of research

·the informed consent process

·protecting privacy and confidentiality

·developing a research agenda for research ethics

·the need for education

·certification and accreditation

·ensuring compliance

·managing conflicts of interest

·institutional review board membership

·monitoring ongoing research

·central or lead institutional review boards

·study of research-related injury compensation issues, and

·the need for resources

NBAC, established in October, 1995, was created to advise the National Science and Technology Council and other appropriate government entities regarding bioethical issues arising from research on human biology and behavior. This is the Commission’s fifth report.

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Apr. 9, 2001

COSSA BOARD MEMBER APPOINTED TO HUMAN RESEARCH PROTECTIONS PANEL

COSSA board member and Executive Officer for the American Sociological Association (ASA) Felice Levine has been appointed to the National Human Research Protections Advisory Committee (NHRPAC). Levine was recommended by COSSA, which urged the expansion of NHRPAC to include greater representation of social and behavioral scientists. She was appointed by former Secretary of Health and Human Services (HHS) Donna Shalala in January.

Levine is part of the 17-member Committee charged to provide expert advice and recommen-dations to the Secretary of HHS, Assistant Secretary for Health (ASH), Director of the Office of Human Research Protections (OHRP), and other department officials on a broad range of issues and topics pertaining to the protection of human subjects.

Prior to being appointed to the Committee, Levine testified before NHRPAC in December regarding human subjects protections and the problems implementation causes for social sciences. NHRPAC has asked that she serve as co-chair of a new social and behavioral sciences working group of the Committee (see Update, January 29, 2001).

Levine joins the only other social and behavioral scientist on the Committee, Jennie Joe, an anthropologist with public health and nursing training. OHRP Director Greg Koski serves as the Committee’s Executive Secretary. For more information see the Committee’s website: http://ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm.

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Feb. 26, 2001

SOCIAL AND BEHAVIORAL SCIENCE COMMUNITY RESPOND TO NBAC REPORT

Commending the National Bioethics Advisory Commission for its “ambitious and impressive undertaking,” the social and behavioral science community responded to the Commission’s request for comments on its report, Ethical and Policy Issues in Research Involving Human Participants. (See Update, December 11, 2000.)

There is much that COSSA agrees with in the report, but we are troubled about a number of the issues raised and some of the recommendations, stated COSSA’s Executive Director Howard Silver. “Although we understand that the recommendations . . . are designed to provide for a major change in the system, our primary question is whether the new system recommended for adoption by the Commission is the optimal system to protect human research participants without unduly burdening researchers,” said Silver.

The social and behavioral science community also expressed its concern with the tone of NBAC’s report. L. Michael Honaker, Chief Operating Officer of the American Psychological Association (APA), noted that it implies “that investigators will not conduct sound, ethical research in the absence of detailed regulation and monitoring. While occurrences of extreme and dramatic abuses have been well-publicized, such behavior is not characteristic of the vast majority of scientific investigators.” APA strongly recommended that the “needs and sensitivities of investigators receive sufficient acknowledgement throughout the NBAC document . . . [which] can be accomplished without compromising the standards for participant welfare and rights.”

Agreeing with NBAC that maintaining the office within the Department of Health and Human Services (HHS) signals that the new system remains centered in a biomedical model, COSSA supports the creation of an independent office outside the agency. “Since much of social and behavioral science research is conducted with support from other agencies, such as the National Science Foundation, we believe that an independent office will better serve the needs of all agencies. It is essential, however, that the new entity has an advisory committee that includes a significant number of members from outside the biomedical sciences. This would allow for sufficient nonbiomedical-centered input into how the new office would operate,” Silver explained.

The American Sociological Association (ASA) “also believes that the current human subjects protection system as it has developed over more than 20 years would benefit from revisiting, in light of limitations of the past, the growing fault lines between how it should operate and how it does, and the changing demands and complexity of research involving human interactions,” emphasized ASA Executive Director Felice Levine in the Association’s comments to NBAC.

Additional Deliberation Urged

Levine urged NBAC to undergo “substantially more deliberation before introducing widespread change.” The draft report “does not directly address how the system needs altering to achieve the goal of creating a revised system for the protection of human subjects that encompasses all research involving human interactions with researchers — irrespective of funding source and area of inquiry — especially for the social and behavioral sciences,” she said. “Especially because the NBAC report calls for expansion, it needs to do so fully appreciative of ethical considerations as they present themselves in the social and behavioral sciences. The report also needs to emphasize the importance of full participation of social and behavioral scientists in all aspects of any system for the protection of research participants,” Levine stressed.

The APA commended the NBAC draft report, applauding the goal of “creating a set of universal principles that are then flexibly applied, as appropriate, to the wide range of disciplinary and individual research contexts.” Honaker noted that it is “extremely informative, both to those who are not familiar with current research policy and its development as well as those who are experts in primary ethical issues pertaining to research with human participants.”

The APA described the draft report recommendations as extremely constructive and useful in outlining issues and mechanisms to ensure that the rights and welfare of research participants are well-protected; however they and the other social and behavioral science organizations emphasized that “the orientation, issues, and examples are primarily derived from and directed toward biomedical and clinical research.” Accordingly, says Honaker, this “diminishes the appropriateness for and applicability to the minimal or less-than-minimal-risk research that forms the bulk of the research conducted in the behavioral and social sciences . . . We suggest that the report explicitly address differences between behavioral and biomedical research in several ways: by including examples from behavioral and social science fields; by further noting that definitions of risk and harm differ qualitatively across behavioral and biomedical interventions; and by additional discussion of mechanisms for oversight of minimal risk.”

Louise Lamphere, President of the American Anthropological Association (AAA), recommended that NBAC “acknowledge in the report that social and behavioral science research and the humanities pose no or minimal risk of harm to human participants and, unless otherwise indicated, qualify for administrative IRB [Institutional Review Board] review.” This would be an expedited process, but would not exempt any research from review, as is currently possible under the common rule.

Catherine Rudder, Executive Director of the American Political Science Association (APSA), observed that NBAC’s draft report “erroneously concludes that research exempted from IRB review is spared from meeting ethical standards. There is no evidence that social science research currently exempted under the Common Rule has spawned research that has endangered human participants. While the draft report acknowledges that social scientists have disciplinary codes of ethics, it discounts the fact that political scientists and their peers in other social sciences abide by their disciplinary codes, the fundamental principle of which is to do no harm to the research participant.”

Calls for Additional Training for IRBs

Given that COSSA’s main objection with the current system is the role of IRBs, Silver stressed that it is essential that their members have appropriate expertise in the research areas that they are reviewing. “Individuals who serve on IRBs should not only receive training, education, and certification in ethics, but should have substantive scientific knowledge and methodological skills as well,” Silver explained.

Similarly, APSA emphasized that “members with only a passing knowledge of other disciplines’ methods are inadequate for the tasks envisioned for them . . . The ‘educational’ programs proposed by the draft report cannot compensate for the lack of training.” If all research is to be reviewed under the NBAC draft report’s plan, “the rules should clearly provide that social scientists, behavioral scientists, and scholars from the humanities should each be represented in sufficient numbers among IRB members,” Rudder maintained.

There is clear opposition to NBAC’s recommendation that 50 percent of IRB members consist of “non-scientist, non-institution members.” Such a ratio detracts from the peer review aspect of research, observed Silver. All of the organizations were adamant in their view that the most important issue is the competence of IRB members in methods and topics of the research under review. Nevertheless, there is community support for an increased number of public members.

The bedrock of a human participant protection system needs to link sound knowledge about research ethics with sound knowledge of research, argued ASA’s Levine. “If anything, the social and behavioral sciences have not always received adequate review because of insufficient expertise regarding ethical principles as they apply to social and behavioral study.” While NBAC’s motivation is well-intentioned, public participation can and should be meaningfully included without compromising the presence of specialized ethical and scientific expertise.

The American Anthropological Association (AAA) registered its concern that “certification may entail standardized tests written to serve the biomedical research community, and that social and behavioral sciences’ perspective and concerns may be absent from certification standards.” Likewise, while the role for professional societies is recognized in the educational component, there is no discussion within the report of how professional societies may assist in the oversight process, Lamphere added. The AAA recommended that NBAC identify key roles for professional societies to play in the proposed accreditation and certification process (see Update, January 9, 2001).

Increased Funding for Research on Ethics Training Needed

Finally, the social and behavioral science community supported the need for increased federal funding for research ethics training. To thoroughly educate scientists and IRBs, opportunities for the best research ethicists to produce educational materials need to be increased, all the groups asserted.

NBAC’s draft report can be found at www.bioethics.gov. Copies of the social and behavioral science community’s comments can be found on COSSA’s website at www.COSSA.org/NBAC.

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Jan. 29, 2001

IOM HEARS CONCERNS REGARDING HUMAN SUBJECT'S PROTECTION

Federal and non-federal organizations continue to examine the issue of human research participants protection. On January 22, the Institute of Medicine’s (IOM) Committee on Assessing the System for Protecting Human Research Subjects held a public forum to gather information for its assessment of the system for protecting human research participants (see Update, January 15, 2001). The Committee heard the various perspectives (institutional, participant, and investigator) of those conducting research involving humans.

Representatives from the Department of Health and Human Services (Office of Human Research Protections, Centers for Disease Control and Prevention, and the Food and Drug Administration), the National Science Foundation, and the Veterans’ Administration also provided testimony. Opening the meeting, Chair Daniel Federman (Dean for Alumni Relations and Clinical Teachings, Harvard) emphasized that the committee will “deliberate thoroughly” before writing its draft report and that no conclusions or recommendations by the Committee would be made at the meeting.

Several individuals offered perspectives regarding the difficult and challenging problem of how to accommodate the social and behavioral sciences in a system based on a model created to deal with biomedical and clinical research.

Felice Levine, Executive Committee member of COSSA and Executive Director of the American Sociological Association, addressed the Committee on behalf of COSSA and from the perspective of researchers. Levine informed the Committee that most of the professional associations within COSSA have developed ethical guidelines for researchers to follow in conducting their research, particularly where human participants are part of the research design. She emphasized COSSA’s concern regarding the “growing fault lines in the system that protects human participants and the gap that has developed between law and policy ‘on the books’ and ‘in action.’” For example, said Levine, researchers utilizing secondary data are being asked to seek approval by Institutional Review Boards (IRBs) to use these data though the information is anonymous and the subjects are already protected under earlier protocols.

Commenting on proposed standards for accreditation of institutions’ human research protection plans, she noted that they provide further evidence of the inherent problem with the current system. If these standards are intended to be universal and to fit all research involving human participants, she said, they need to be framed in a way that meaningfully includes all research fields.

Levine informed the Committee that the social and behavioral science community framed its concerns as ten recommendations. COSSA’s written testimony will provide specific illustrations of where the social and behavioral science community thinks that accreditation standards are problematic for achieving the proposed goals and where they are specifically problematic for the social and behavioral science community.

1. Seize the moment for effective leadership on behalf of all science. The IOM has the opportunity to provide guidance on an accreditation system and a human research participant protection system that effectively reaches all areas of research and effectively serves all Federal funding agencies engaged in the support of such research — not just the biomedical sciences.

2. Slow the process down sufficiently to ensure quality. There is virtue in moving ahead, but there is also virtue to slowing the process down enough to ensure that the standards are meaningful for all science. If the standards for accreditation are to be more effective than the current process for obtaining assurances of compliance under the Common Rule, then the two important IOM studies (concerning the overall structure and function of human participant activities, including IRBs, and criteria for evaluating the performance of human subject protection activities) yet to be undertaken should logically proceed before crafting and finalizing accreditation standards (a message echoed by several participants).

3. Ensure That the Many Pieces of the Common Rule Fit. The proposed accreditation standards integrated many pieces of the Common Rule but use these regulations in a different context, often coupled with other ideas. The disjuncture between the Common Rule and accreditation standards needs careful analysis.

4. Attend to the Details. The proposed standards are not couched in the language of any one science or arena of research per se, but when coupled with the commentary, are biomedical and heavily clinical. Accordingly, they pay only lip service to other substantive arenas of work; this is especially problematic for the social and behavioral sciences. If the commentary will be presented, its role needs to be clear and the examples across areas of research specified.

5. Ensure That the Standards Emphasize Accrediting the Structure and the Procedures That Are Followed. While good ethics makes for good research, judgments of best ethical practices are distinct from judgments about the quality of the research. The proposed accreditation standards overreach what constitutes quality science and what constitutes ethical practices in science. The standards shift from the criteria for the accreditation of Institutional Review Boards to the assessment of the research and the researcher.

6. Assure Clarity, Simplicity, and Transparency; These Attributes Are Fundamental to Accreditation Standards of Excellence. Many of the standards require judgments that are impossible to make. The standards should not tell an institution how it should achieve its goals, but should set forth what the standards or goals are.

7. Guarantee That the Standards Provide Education About How IRBs and the Human Research Protection System Should Operate. The proposed standards, especially the commentary, provide little in the way of education, particularly with regard to the social and behavioral sciences.

8. Safeguard the Human Research Protection System by Ensuring That It Does Not Overreach Its Role and Stays on Task. The human research protection system needs to ensure that research proceeds and knowledge are advanced in accordance with the highest standards of ethical practice with respect to human participant protection. The system needs to ensure that work that comports to ethical standards is facilitated and not impeded by the process.

9. Assure That the Accreditation Standards Clarify What the Scope of the Human Protection System Is and Is Not. Human research participants refer to actual participation in a study underway or being proposed. The analysis, for example, of public-use data where information is maintained in anonymous form and without personal identifiers is research about people but not on people.

10. Focus on the Ethical Considerations Regarding Human Research Participants in Various Types of Research. The answer to the concerns in the social and behavioral sciences is not necessarily to “specialize” the review process but to ensure a system that is more sophisticated about ethical practices across fields of science. Social and behavioral research is increasingly interdisciplinary within these fields and across other arenas, especially biomedical, environmental, and engineering fields. Separation of the review by field could create redundancy and limit researchers mutually benefiting from the ethical expertise of each other.

Levine emphasized that COSSA believes this guidance can help structure the next round of revisions for a final set of “testable” accreditation standards. COSSA, the social and behavioral science societies, as well as many, many top quality researchers behind us are eager to help in any way that we can, Levine concluded.

Comments from Federal Agencies

Several of the agencies that are part of the “Common Rule” offered insight from their agency. The Department of Health and Human Services (HHS) considers accreditation the cornerstone of overall improvement of the human participant system, stated Irene Stith-Coleman, Public Health Advisor to the Assistant Secretary of Health and the Surgeon General. Her comments were made on behalf of the agency and Office of Human Research Protections (OHRP) Director Greg Koski. The Department envisions a system of objective, uniform, nationally-recognized standards that provide the basis of accreditation, she stressed. The two-year IOM study, requested by OHRP, is designed to realize this system.

According to the Centers for Disease Control and Prevention (CDC) Deputy Associate Director for Science John R. Livengood, there are three areas of concern for the CDC: 1) diversity of IRBs; 2) ownership of the standards; and 3) plans for implementation. While the CDC agrees with the overall process, the agency asks the Committee to be sensitive to the entire range of IRBs. The CDC, said Livengood, believes that it is “important to strengthen the IRBs.” Further, CDC encourages the Committee to realize there are other IRBs, “other than those associated with medicine.” To narrow the focus on the biomedical models may create unintended consequences, stressed Livengood, noting that the CDC works with many partners. With regard to the ownership of the standards, Livengood emphasized that the copyrighted standards “strike the wrong tone.” He noted that for implementation purposes, any final standards must be adaptable to different situations.

Philip Rubin, Director of the Behavioral and Cognitive Sciences Division at the National Science Foundation, expressed concern with the proposed standards and their impact on the social and behavioral sciences. Rubin warned the Committee that the draft standards have the potential to cause harm if a different kind of expertise is needed on IRBs, other than biomedical and clinical. He highlighted the fact that interdisciplinary research is a priority throughout the sciences and the federal research agencies. Rubin further stressed that the federal government also collects data (e.g., Panel Study of Income Dynamics, housing, education, and medical care) and that the proposed standards could be detrimental to the federal government’s ability to collect that data. Finally, Rubin reminded the Committee that it has an opportunity to be responsive to the needs of the social and behavioral sciences, emphasizing that the current standards are not.

Stephen Erickson, Director of the Office of Research Administration at Boston University, informed the Committee that his University was rapidly becoming more research intensive, overwhelmingly behavioral in nature. Erickson made several observations regarding the proposed standards:

· The standards appear to have been drafted with large academic biomedical and clinical programs in mind.

· The standards are so detailed as to impede flexibility.

· To participate in a voluntary accreditation process places additional administrative costs and burdens on institutions.

· Benefits to participating need to be made clearer. Benefits should outweigh the costs of participating.

· There is a need to incorporate a statement describing the accreditation process.

· Two core questions need addressing in the review/redraft of the standards: 1) Will the standards assist different sizes of institutions to better fulfill their mission?; and 2) Do the standards facilitate the work of IRBs, institutions, and researchers?

Written comments (to be considered in deliberations) on the proposed standards (which have not been endorsed by the committee) must be received by the IOM by February 2, 2001. The standards can be found on the IOM website at: www.iom.edu/IOM/IOMHome.nsf/Pages/human+ research+protections. COSSA’s written comments will be posted on our website (www.cossa.org) by February 2, 2001.

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Jan. 15, 2001

HUMAN SUBJECTS PROTECTION: A MULTITUDE OF ACTIVITY

With heightened awareness after the death of a research participant at the University of Pennsylvania and reports of abuses that led to temporary suspensions of research activity in other places, the protection of human research subjects has drawn the major attention of government and non-governmental bodies. A flurry of activity is underway to assess and strengthen the system of assuring that people who volunteer to participate in research are not subject to harm.

In all of these activities, the need to balance the protection of human subjects without the undue burdening of research and researcher becomes a difficult act. In addition, how to accommodate the social and behavioral sciences in a system that is based on a model to deal with biomedical and clinical research is another difficult problem.

On December 21, the Department of Health and Human Services’ (HHS) National Human Research Protection Advisory Committee met for the first time. Chaired by Mary Faith Marshall, Professor of Medicine in the School of Medicine, and Bioethics Officer at Kansas State University Medical Center, the panel is closely connected to the Office of Human Research Protection headed by Greg Koski (the Committee’s executive secretary). The Committee includes one social/behavioral scientist among its 12 members: Jennie R. Joe, Professor of Family and Community Medicine at the University of Arizona. Joe is a cultural anthropologist with a nursing degree who has conducted research and demonstration projects among Native Americans. COSSA has written HHS Secretary Donna Shalala to ask for more social/behavioral scientist representation on the panel.

After hearing Secretary Shalala describe the Committee’s task as “very important,” and listening to Senator Edward Kennedy (D-MA) review the history of the federal government’s involvement in this area, the panel turned its attention to the social and behavioral sciences. Felice Levine, Executive Officer of the American Sociological Association and then-Chair of the COSSA Executive Committee, addressed the panel on how the social and behavioral sciences viewed the situation. Levine based her remarks on the paper prepared by Jonathan Knight of the American Association of University Professors (see Update, December 11, 2000) and her involvement with the working group that helped produce the paper.

Levine noted that the many assessments presently occurring provide an opportunity to rethink the system so that it protects research participants and promotes ethical and excellent research. She wants the committee to take a hard look at the “gaps” in the system between principle and practice, particularly with respect to the review and approval process of social science research. She suggested there has been a very troubling, growing “fault line” between the mandated purposes of the system of regulating research and its operations.

The key to reforming the system, Levine argued, involves altering the very structure of the Institutional Review Board (IRB) process itself. “At a minimum, this would mean a different thinking about the compositions and expertise on IRBs, on staffs, on advisory commissions, and on any accreditation groups to be established,” she declared.

She noted the six categories of research that are explicitly exempt under the Common Rule that governs the protection of human subjects. What those types of research have in common is that they pose little or no risk of physically or mentally harming human subjects. Whether a risk is more than minimal is for an IRB to decide. Levine expressed concern that the bases of these decisions now vary even within IRBs of the same institution, as well as across institutions. The quality of IRB decisions ultimately depends on the experience of the IRB members. Levine worried that those members not familiar with social science research can have a difficult time discerning the putative benefits of research. At the same time, problems also arise if IRB members indiscriminately apply standards of research drawn from a clinical or biomedical perspective to the social sciences.

She also discussed informed consent and expedited review problems. With regard to the former, she suggested that IRBs “may be prone to implement the Common Rule too literally and mechanistically and with little consideration of the diverse nature and ethical requirements of research.” She is concerned with how expedited review will work as the responsibilities of IRBs expand in response to the concern that they must be more vigilant in protecting human subjects. She advocated for opportunities to provide blanket exemptions for certain types of research (e.g., survey or oral history).

After the presentation, the Committee concluded that it needed to reach out further to the social science community, and it agreed to issue a formal request for guidance on how to proceed with the question of how to approach issues particular to non-biomedical research. They also sought answers to a series of questions concerning the social sciences, including: How many social/behavioral scientists are members of IRBs? How many social/behavioral science protocols are considered by IRBs? How many social science protocols are rejected because of potential psychological or emotional risk to the subjects? How should risk be defined for these sciences?

Meanwhile, at the Institute of Medicine . . .

An Institute of Medicine (IOM) Committee, Assessing the System for Protecting Human Research Subjects, held its inaugural meeting on December 18 for a two-year study to address three interrelated topics surrounding the issue.

The IOM study is in response to a request from the Department of Health and Human Services= (HHS) Office of Human Research Protection (see Update, September 25 and November 6, 2000). Daniel Federman, M.D., Dean for Alumni Relations and Clinical Teachings at Harvard University, chairs the Committee.

The topics the Committee is addressing include:

1. Accreditation standards for Institutional Review Boards (IRB)

2. The overall structure and functioning of human subject protection activities, including, but not restricted to, IRBs

3. Criteria for evaluating the performance of human subject protection activities

Phase I (which is on a fast track) of the two-phase study is a six-month study on accreditation standards for IRBs. A report on accreditation is scheduled for release on April 1, 2001. To meet its deadline, a public meeting has been scheduled (January 22, 2001, 1:00 to 5:30 p.m.) to receive input for the report. According to the Committee, a major objective of the meeting is to provide the opportunity for public comment, in particular on the draft standards for an independent voluntary accreditation system proposed by the Public Responsibility in Medicine and Research group (PRIM&R). PRIM&R=s proposed standards are available at www.iom.edu/hrrp.

At the December meeting, Sanford Chodosh, President of PRIM&R, discussed the standards and process. The underlying goal of the standards, said Chodosh, is to improve the protection of human research subjects. He also emphasized that the goals of PRIM&R include creating performance standards and fostering the organization of a second body to carry out the accreditation process.

Chodosh noted that the standards address three areas: institutions, human subject research protection programs, and investigators. PRIM&R, Chodosh said, has struggled to make the standards applicable across the human research spectrum. Areas not adequately covered by regulations, he continued, were given special consideration. He informed the Committee that the draft standards include input from the IOM.

The plan, Chodosh explained, is to test the standards in pilots and to license the copyright standards to the Association for the Accreditation of Human Research Protection Programs (AAHRPP), currently in the process of incorporation. Once AAHRPP is established, the intent is to assess the accreditation process and make the appropriate changes where necessary.

Chodosh concluded by noting that while PRIM&R had an obligation to give IOM a document, they can continue to amend the revised document. The intent is to publicize the standards, he said.

Phase II will be a 24 month study of the structure, function, and performance of human subject protection activities. The report from Phase II of the study is expected to be released in September, 2002.

Any questions regarding the project should be addressed to Laura Lyman Rodriguez, Study Director, Board on Health Sciences Policy at 202/334-3193; email: lrodrigu@nas.edu.

The National Bioethics Advisory Commision’s (NBAC) draft report on the oversight of human subjects protection is still available for comment (see Update, December 11, 2000).

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