Protecting Human Research Participants
a compilation of stories from COSSA Washington Update regarding the oversight of human research participants
|Human Subjects Committee Members Appointed by HHS Secretary||
January 13, 2003
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
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:
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:
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.
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
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.
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:
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:
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
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 106th 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.”
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
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
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.
Journalism, Ethnography as
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
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
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
January 24, 2002
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.
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
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
Ethics Research Needed
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
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.
of the report and the accompanying commissioned papers can be downloaded
or requested via the NBAC website: www.bioethics. gov.
Council on Bioethics
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
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.
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.
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.
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
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
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.
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.
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.
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
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.
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.
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
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
from each organization served on the search committee for the executive
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.
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.
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.”
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
Use Data Files
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.
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.
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.
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.
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.
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.
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.
Investigators seeking to merge public data files or enhance a
public data file with identifiable data should obtain IRB review and
8. A web-based training module on confidentiality issues
involved in the preparation and analysis of public data files should be
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.
OHRP should issue guidance to IRBs, the research community, and
others associated with the human participant protection system regarding
the definition of minimal risk.
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
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
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
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.
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.
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.
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
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
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.
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.
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.”
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.
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.”
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.
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.”
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.
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
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.
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.
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
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.
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.
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
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.
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.
also heard from professional associations, including COSSA members.
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.
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.
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.
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.
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
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,
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.
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.”
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
released its recommendations during its 48th 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.
addition to changes at the national level, NBAC’s recommendations also
review of research
informed consent process
privacy and confidentiality
a research agenda for research ethics
need for education
conflicts of interest
review board membership
or lead institutional review boards
of research-related injury compensation issues, and
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.
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.
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
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
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.
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.
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
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.
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
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
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.
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).
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
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.
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
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.
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
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.
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.
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,
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
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
· 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.
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
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?
at the Institute of Medicine . . .
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 Committee is addressing include:
Accreditation standards for Institutional Review Boards (IRB)
2. The overall structure and functioning of human subject
protection activities, including, but not restricted to, IRBs
Criteria for evaluating the performance of human subject protection
(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).
proposed standards are available at www.iom.edu/hrrp.
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.
noted that the standards address three areas:
institutions, human subject research protection programs, and
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.
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.
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.
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
questions regarding the project should be addressed to Laura Lyman
Rodriguez, Study Director, Board on Health Sciences Policy at
202/334-3193; email: firstname.lastname@example.org.
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).