Research Proposal on Ethic by cun10681


Research Proposal on Ethic document sample

More Info
									                                                      R E G U L A R        A R T I C L E

The New Research Ethic: Will
Oversight Requirements Sink
Forensic Research?
Philip J. Candilis, MD, Rasim Arikan, MD, Sheila B. Noone, PhD, and
Jacob C. Holzer, MD

The conduct of research with human participants is facing increased scrutiny from government, media, and
academic sources. Research oversight is consequently increasing dramatically as education and accreditation
movements gain momentum. Institutional review boards themselves are undergoing significant changes in organi-
zation and accountability, implementing new tools to monitor investigator compliance. This article describes the
causes of recent calls for increased scrutiny, the resultant trends in research oversight, and the general lack of
preparation for increased costs in the public sector. These are costs that will be felt acutely in the forensic setting
as diminishing state budgets affect hospitals, universities, and correctional institutions.

J Am Acad Psychiatry Law 33:361–7, 2005

Increasing criticism of the research enterprise in the                     Recent Problems in Research Oversight
United States has created strong pressure to improve                          In 1996, the U.S. General Accounting Office re-
oversight and review. Government agencies, citizen                         ported that heavy workloads and a lack of resources
advocacy groups, media, and researchers alike, are                         were undermining research review by institutional
exerting pressure that has significant implications for                    review boards (IRBs).1 In 1998, the U.S. Depart-
biomedical investigations involving human subjects.                        ment of Health and Human Services (DHHS) In-
This is especially true of forensic research that is con-                  spector General described disturbing trends in com-
ducted with participants who may need greater pro-                         mercialization of IRBs, increased IRB-shopping by
tection by virtue of their vulnerability as prisoners or                   researchers seeking speedy approval, and an increase
chronic care patients. Federal regulations already re-                     in private review boards not operating under stan-
quire increased consent and monitoring procedures                          dard scrutiny.2 The recent work of the U.S. govern-
for research with vulnerable populations, including                        ment’s Advisory Committee on Human Radiation
prisoners. A review of recent scandals and trends in                       Experiments (ACHRE) identified incomplete expla-
the research review system and their costs will clarify                    nations of risk and benefit in government-conducted
the future influences on research already conducted                        research and serious ethics-related concerns in a sig-
under a higher degree of vigilance.                                        nificant number of protocols.3,4
                                                                              In acknowledging a vast array of concerns, the
                                                                           Department of Health and Human Services in 2001
                                                                           commissioned the Institute of Medicine (IOM) to
Dr. Candilis and Dr. Holzer are Assistant Professors of Psychiatry, and
Dr. Noone is Director of Clinical Research Operations and Oversight,       conduct a “comprehensive assessment of the national
Office of Research, University of Massachusetts Medical School,            system for protection from research risks.” The re-
Worcester, MA. Dr. Arikan is attending psychiatrist at Worcester State
Hospital, Worcester, MA. The work of Dr. Candilis is supported by a        sults of this assessment are included in the IOM’s
National Institutes of Health (NIH) career development award in            landmark report: “Responsible Research: A Systems
research ethics mentored by Paul Appelbaum and Charles Lidz
(K01MH01851). The views expressed in this article do not necessarily       Approach to Protecting Research Participants.”5
reflect those of the NIH. Address correspondence to: Philip J. Candilis,   Contemporaneously, prominent ethicists began to
MD, University of Massachusetts Medical School, 55 Lake Avenue
North, Worcester, MA 01655. E-mail: philip.candilis@umassmed.              call for a move from “compliance to conscience,”
edu                                                                        requiring a broader sensitivity to the vulnerabilities

                                                         Volume 33, Number 3, 2005                                           361
                                               New Research Ethic

of research subjects and more than mere compliance           The OHRP proposes an initially voluntary pro-
with research regulations.6,7                             gram of quality assurance, quality improvement,
   Responding to specific negative outcomes at cer-       and, ultimately, continuous quality improvement
tain centers, the federal government suspended re-        (CQI). Quality assurance takes the form of an insti-
search at over 12 centers nationwide, and published       tution’s self-assessment of research protections,
severe criticisms of their review procedures.8,9 Now      guided by OHRP’s Division of Assurances and
concern has spread to international AIDS research         Quality Improvement. A self-assessment tool devel-
conducted by U.S. researchers under lower local           oped by the division gauges compliance with federal
standards of consent and review.                          regulations.
   More intensive oversight of human research had            This survey tool contains detailed questions re-
also arisen from public and media responses to seri-      garding workload and staffing resources, the number
ous adverse events.10,11 Following the death of Ellen     of reviews conducted during meetings, and even the
Roche, a healthy volunteer in a Johns Hopkins Uni-        length of meetings themselves. It asks whether IRBs
versity protocol, Maryland’s governor signed legisla-     have their own budgets, conduct their own internal
tion to grant greater public access to IRB minutes,       audits, and document the amount and frequency of
making the decision-making process more “transpar-        training. It asks whether IRBs solicit written status
ent.”12 The tragic death of teenager Jesse Gelsinger in   reports from investigators during continuing review.
a recombinant DNA protocol at the University of           The DHHS is not merely concerned with the time
Pennsylvania had already led to Congressional hear-       spent reviewing each protocol, but on adequate re-
ings and the first lawsuit ever against a research        sources for staff, reviewers, and monitoring. It offers
ethicist.13,14                                            a systematic process for oversight that goes well be-
   In April 2002, the U.S. Senate heard testimony         yond the model in place at most research institutions.
espousing a national Human Research Subjects Pro-            Following self-assessment, institutions are asked
tection Act. The proposal included provisions for         to interact with OHRP by written correspondence,
increased public scrutiny of research decisions, in-      teleconference, videoconference, or on-site consulta-
cluding scrutiny of specific protocols and methods.15     tion. Subsequent quality improvement emphasizes
                                                          those mechanisms that best improve research protec-
New Standards for Research Oversight                      tions. Best practices, effective procedures, and tools
   Under this new level of scrutiny, numerous insti-      are to be posted by OHRP as a model for other
tutions are undertaking systematic review of over-        institutions. Moreover, OHRP offers to broker net-
sight practices and offering new standards for the        working relationships between responding institutions.
ethical conduct of research. From the U.S. Depart-           CQI then takes effect at institutions volunteering
ment of Health and Human Services to the Institute        for this program, guided by the previous process of
of Medicine, scholars and leaders in the field are        quality assurance and improvement. In a hint at its
making a change in the manner in which research is        hopes for the future scope of this model, OHRP
conducted. The standard of presumed ethical con-          anticipates 60 such consultations per month from
duct among investigators, a bulwark of research eth-      the 7600 institutions holding research compliance
ics for decades, may no longer apply. Focused heavily     contracts with the federal government.
on new levels of accreditation and monitoring, a new         Several distinct efforts are under way nationally to
ethic of scrutiny is overtaking human experimentation.    promote formal accreditation of human research
   The Office of Human Research Protection                protection programs, one through the federal gov-
(OHRP) within the U.S. Department of Health and           ernment’s Veterans Administration. The 150 VA
Human Services oversees federally funded research         hospitals conducting human research are now con-
within the United States. With its recently doubled       tracted with the independent, nonprofit National
staff, OHRP has taken the role of federal oversight to    Committee on Quality Assurance (NCQA) to apply
a new level. In announcing a new quality improve-         new standards for human subject protections. Orga-
ment program, the OHRP notes its move from a              nized into six domains, this self-described “system-
“reactive, compliance-focused system of oversight         atic and comprehensive program” surveys institu-
and sanctions” to one that is “not only proactive, but    tional responsibilities, IRB structure and operation,
interactive, and emphasizes prevention of harm.”16        consideration of risks and benefits, subject recruit-

362                      The Journal of the American Academy of Psychiatry and the Law
                                           Candilis, Arikan, Noone, et al.

ment and selection, privacy and confidentiality, and         the literature, that research review requires more time
informed consent.17                                          than overworked IRBs can afford. Moreover, in an-
   Prominent in NCQA’s model is the creation of an           other appeal to standardization, PRIMR urges “ad-
institution-wide Human Research Protection Pro-              ditional thought and consideration” to the need for
gram (HRPP). This network of individuals and com-            greater uniformity at institutions with more than one
mittees takes collective responsibility for the work-        IRB.
ings of research at the institution. It includes                Support for quality improvement is reflected in a
institutional officials, research and development            standard calling for “regularly assessing outcomes
committees, IRBs, IRB staff, investigators, research         and improving performance” of the entire Human
staff, research pharmacists, and the like. An accredi-       Research Protection Program. This move toward
tation survey tests the existence and comprehensive-         comprehensive assessment of research oversight in-
ness of policies and outcomes at each level.                 cludes solicitation of views of research subjects as well
   The accreditation survey assesses the institution’s       as views of the communities that supply them. In
own evaluation of HRPP effectiveness and its con-            even stronger language PRIMR asserts that each re-
duct of evaluation and improvement programs, in-             search institution “must” (as opposed to “should”)
cluding measuring, assessing, and improving compli-          propose its own evaluative assessments “of all aspects
ance with HRPP policies. The process also evaluates          of the HRPP.”18
monitoring of investigator performance, according               Nor does PRIMR shrink from the need for more
to standards such as internal and external audits or         resources to finance appropriate oversight, particu-
other monitoring reports that generally lie outside          larly in the new age of accreditation and monitoring.
current IRB practices.                                       Sufficient resources, staff, equipment, and technol-
   Like OHRP, NCQA’s accreditation survey asks               ogy must follow an institution’s determination of
whether IRBs are provided sufficient resources. Spe-         what is adequate. The input of IRB members and
cifically, it asks whether budgeting takes into account
                                                             staff is a specific requirement, just as in NCQA’s
the volume of reviews and feedback from IRB mem-
bers and staff, emphasizing the lack of influence per-
                                                                In another standard heeding the call for greater
ceived among those who currently conduct the na-
                                                             communication with supporting communities,
tion’s research review.
   The organization Public Responsibility in Medi-           PRIMR requires “evidence” of communication with
cine and Research (PRIMR) provides some of the               representatives of the “geographic and/or subject
field’s most widely attended educational conferences         communities” that provide research subjects. Famil-
in research ethics. It trains hundreds of researchers        iarity with the community’s values has been a theme
and research administrators annually. An advocate of         for many in university communities who have been
improved research standards for investigators and            surprised to discover the kind of research conducted
IRBs, PRIMR published its own standards for IRB              in their own backyards. In this context, PRIMR spe-
accreditation.18 Its support for development of Hu-          cifically mentions research involving Native Ameri-
man Research Protection Programs is in line with the         cans, a topic of some sensitivity in the U.S. research
NCQA and underscores the move toward a more                  community.
comprehensive institutional responsibility for re-              The IOM subsequently weighed in on research
search conduct.                                              oversight as well. With a directive from the U.S. Sec-
   PRIMR’s accreditation program, also voluntary, is         retary of Health and Human Services to improve
in two phases: development of “objective, outcome-           “the structure and function of human research re-
oriented performance standards” to serve as formal           view programs” (Ref. 19, p 1) the IOM reviewed
measurement criteria and on-site visitation. PRIMR,          standards proposed by both PRIMR and NCQA. It
too, endorses formal accreditation of IRBs by use of         endorsed the latter.
universal standards.                                            First, the IOM supports the use of a broader sys-
   Among the standards PRIMR proposes is that re-            tem for overseeing conduct of human research. It
search organizations must match the number of IRBs           endorses formation of Human Research Participant
to the volume (and type) of research conducted. This         Protection Programs (HRPPPs), similar to NCQA’s
responds directly to the concern, well established in        HRPP. The IOM is supportive of NCQA’s quality

                                           Volume 33, Number 3, 2005                                              363
                                               New Research Ethic

improvement program and its explicit assessment of        of the role of accreditation in improving human sub-
compliance with federal regulations.19                    ject protections.
   The IOM’s performance assessment arm of the
HRPPP is comprehensive; it encompasses monitor-           Response of Psychiatric Organizations
ing of research, provision of education, and conduct         This change in the conduct of American research
of quality improvement. New elements include for-         has not been lost on the nation’s psychiatric organi-
mation of ombudsman programs, and self-assess-            zations. The American Psychiatric Association, for
ment of oversight programs, outcomes, and support.        example, named a task force on research ethics in
In this way, IOM mirrors NCQA’s requirements by           2000. Advised by IOM members Paul Appelbaum
offering an entirely new tier of communication be-        and Richard Bonnie, the task force is considerably
tween IRBs and the research they review.19                influenced by the IOM’s approach. Now completing
   The IOM would like NCQA’s program to go fur-           its work, the task force has been acutely aware of its
ther, however. Especially in the review of investiga-     mandate to assure research participants are suffi-
tors, the IOM calls for more than the usual docu-         ciently protected by appropriate oversight and mon-
mentation of informed consent and protocol review.        itoring. It is deriving recommendations from first
CQI mechanisms are strongly recommended. In a             principles (i.e., respect for persons, beneficence, and
further broadening of scope, the IOM asserts the          justice) and identifying critical elements of oversight
need for assessing research sponsors themselves and       that must be in place to protect psychiatric research
supports involvement of research participants in set-     participants.
ting performance standards.19                                The American Academy of Psychiatry and the Law
   Moreover, the IOM calls for collection of baseline     (AAPL) has also addressed the advancing tide of im-
data on the current research review system and the        proved research oversight. In the process of revising
piloting of accreditation programs following its          its ethics guidelines AAPL considered an ethics
model. They assert that formal study of the current       guideline specifically for the conduct of forensic re-
and future state of research oversight requires federal   search. Preliminary drafts contained wording sup-
investigation by both the General Accounting Office       portive of applying the regulations governing feder-
and the Department of Health and Human Services           ally funded research to all research, whether federally
Inspector General.19 In this view, the systematic         funded or not, and urged familiarity with the moni-
overhaul of research oversight will not proceed by        toring and accreditation movements. The applica-
half measures. It will require broad-based funding,       tion of the federal protections of vulnerable popula-
endorsement, and support.                                 tions (namely, prisoners, children, and others) to
   The newly developed Association for the Accred-        non-federally funded research is an important step in
itation of Human Research Protection Programs             standardizing oversight guidelines. Moreover, it is
(AAHRPP) takes a similar view. Founded by seven           hoped that the monitoring and accreditation vocab-
eminent institutions (including the Association of        ulary will enter discussions of forensic research over-
American Medical Colleges, the Association of             sight as well.
American Universities, the National Health Coun-             The themes in this movement toward a more
cil, and PRIMR), this body supports a three-pronged       stringent research ethic can be categorized as follows:
accreditation process that includes self-assessment by       1. A broadening of institutional responsibility for
institutions, on-site evaluation, and review by an ap-    research conduct, exemplified by formation of Hu-
pointed council. Standards are based on PRIMR’s           man Research Participant Protection Programs (the
approach and are intended to conform to the IOM’s         HRPPPs);
recommendations. Institutions contact AAHRPP                 2. Formal accreditation of research review com-
for accreditation, pay a fee, and remain current by       mittees and HRPPPs;
maintaining the association’s standards. Evidence of         3. Standardization of research review with stan-
AAHRPP’s increasing importance in research over-          dards based in continuous quality improvement;
sight is its recent receipt of a three-year grant from       4. Monitoring over the course of research, not
the Centers for Disease Control and Prevention            simply at annual review or after adverse events; and
(CDC), announced in a September 30, 2003, press              5. Commitment of greater resources to research
release.20 Primary among its goals is the assessment      oversight.

364                      The Journal of the American Academy of Psychiatry and the Law
                                           Candilis, Arikan, Noone, et al.

Funding the New Oversight Movement                           the federal government, in response to the move-
   It is the commitment of greater resources that will       ment to enhance research protections, published a
be most problematic for forensic and other public            Request for Applications (RFA) in 2002 to provide
sector research. As noted earlier, this is research that     institutional support for improved oversight (e.g.,
already requires greater procedural protections be-          RFAs OD-02-003, OD-03-007). Others have begun
cause of the vulnerability of the populations (e.g., in      to call for study of IRB deliberations themselves, to
correctional, chronic care, and state hospital set-          assure that new procedures and costs will provide real
tings). Although the costs of research oversight have        improvements in the conduct of research.25
rarely been studied in the professional literature,              There remains little literature on current costs,
there is no lack of consensus that costs are high. The       however, and so there is even less preparation for the
University of Texas, San Antonio, conducted the ear-         increases that are anticipated. At our own institution
liest study of IRB costs in 1979.21 Drawn from in-           (the University of Massachusetts Medical School),
ternal funds, costs of their medical school IRB was          the annual costs of maintaining oversight of human
estimated at $100,000 per year, a significant expen-         subjects protection are greater than $400,000. In-
diture for a high-volume IRB at the time. With the           cluded in this budget are salaries, travel, meetings,
increased complexity of protocols and regulations            and memberships for three full-time staff (IRB Man-
since then, however, it is not possible to translate         ager, IRB Coordinator, and Administrative Assis-
these costs into modern dollars.                             tant) and a small portion of salary support for the
   The next study of this kind was conducted in 2003         IRB Chair. Less visible costs of human subject pro-
within the Veterans Administration (VA).22 Using             tection arise from two other layers of responsibility:
current “benchmark standards” for administering a            an estimated 75 percent effort of the director of the
single high-volume IRB, the VA allowed for a full-           office (who facilitates education, training, and devel-
time professional staff to administer 300 to 350 pro-        opment of an internal inspection program for quality
tocols per year, a standard described but not explic-        improvement) and 80 percent effort of a regulatory
itly justified by prior analysis.23 According to this        specialist (who assists investigators with regulatory
standard, a high-volume IRB would require eight              documents and assists the director in study inspec-
committee support staff, a full-time administrator, a        tions). Beyond these obvious costs are those that are
full-time administrative assistant, and a database an-       currently incalculable: the research reviews by con-
alyst. With a chair and nine committee members,              flict of interest and Health Information Portability
weekly meetings would draw portions of salary rang-          and Accountability Act (HIPAA)/privacy officials
ing from 0.05 full-time equivalent (FTE) for a com-          and the institution’s legal department.
mittee member to 0.5 FTE for its chair. The esti-                Within the Massachusetts Department of Mental
mated institutional cost in this model is over $1.2          Health, there is no budget line item for research re-
million per year.                                            view, with direct costs of operating the institutional
   These analysts observed that high-volume IRBs             IRB, including partial salaries for a director and sup-
are more efficient than IRBs conducting less frequent        port staff, mailing, parking, and copying fees esti-
reviews, with costs per protocol significantly higher        mated to be less than $100,000 a year (Altaffer F,
among low-volume IRBs. With many small IRBs                  Co-Chair, Massachusetts Department of Mental
located at hospitals that draw IRB support from pa-          Health Central Office IRB, personal communica-
tient care funds, serious limitations on research over-      tion, October 2004). For an IRB reviewing 10 per-
sight may result at financially strapped state               cent of the VA’s number of protocols (30 – 40 per
institutions.                                                year), this is proportionately less than the benchmark
   Even more troubling is the observation that these         standard ($1.2 million for the VA IRB/$120,000 in
IRB estimates do nothing to predict the cost of a full       adjusted dollars for the Department of Mental
oversight system’s (e.g., an HRPPP) quality manage-          Health). There is no separate budget for indirect
ment, training, and administrative missions. Com-            costs of executive managerial staff, office, or confer-
mentators such as the National Bioethics Advisory            ence room overhead. Nor is there reimbursement for
Commission have already begun to call for portions           the time of volunteer IRB members to travel and
of grant funds to be reserved for oversight.24 Indeed        prepare for meetings. Area monitoring committees

                                            Volume 33, Number 3, 2005                                           365
                                                 New Research Ethic

that volunteer to oversee ongoing research also have        health expenditures resulting in the provision of less
no budget.                                                  than 2 percent of mental health dollars.30 With psy-
   The Massachusetts Department of Corrections              chiatric beds most vulnerable in the case of mergers
similarly has no separate budget item for research          and acquisitions, many hospitals have reported the
review and oversight (Kohl R, Director of Research          intent to cut their complement of psychiatric beds.31
and Planning, Massachusetts Department of Correc-              This short-sighted view of mental health needs
tions, personal communication, October 2004). Re-           provides little encouragement for the research enter-
view is part of the work of the Director of Research        prise, especially given the oversight movements now
and Planning, who reviews proposals, interacts with         gaining momentum.
prison superintendents, and determines not only the
appropriateness of the research but its feasibility
within the correctional setting. There are no projec-       Conclusions
tions for the cost increases that will arise from accred-      As mental health budgets are cut and professional
itation and increased oversight.                            staffing is decreased, research oversight conducted by
   It is possible that the advent of the HIPAA, which       these institutions and their research reviewers will
affects research as well as clinical care, provides an      suffer. Public sector research oversight will not be
indication of where greater costs will arise. Although      able to keep up with the important new standards.
numbers are scarce in this area as well, institutions       With even a $100,000 annual drain on an institu-
incur significant costs from new data protection and        tion’s research budget, greater oversight costs would
transfer technologies, new practices and policies, and      mean significantly less support available for major
new staff training requirements.26 Some have already        grants (and hence less competitive proposals), less
observed significant (and costly) changes in IRB            health services research (as on the interaction of po-
practices under HIPAA, including increased revi-            lice or judges with persons with mental illness), and
sions and less expedited review.27 Research on costs        fewer training slots for forensic professionals, many
prior to these studies has been appropriately charac-       of whom conduct research as part of their education.
terized as of limited quality and low statistical           At our own Center for Mental Health Services Re-
power.28                                                    search, for example, a $100,000 diversion to research
   A specific proposal from our institution suggests        oversight would supplant one faculty member and a
the scope of technology that may be necessary to            research associate (Lidz CW, Director, Center for
absorb the anticipated changes. An electronic sub-          Mental Health Services Research, Department of
mission tool for IRB proposals is proposed for sim-         Psychiatry, University of Massachusetts Medical
plifying and auditing increases in research oversight.      School, personal communication, February 2005).
The proposed tool includes tracking of IRB decision-           If research in correctional settings or state hospi-
making as well as oversight mechanisms, but would           tals is to continue, it will have to overcome not only
require an initial investment of $100,000. The hu-          the crisis of confidence created by research scandals
man and technical support requirements would ulti-          and public scrutiny but a crisis of finances as well. In
mately be far greater. Nor does this speak to the           the current social and economic climate the promise
education, long-term training, and equipment                of improved treatments, diagnoses, and risk assess-
needed to link investigators to an established com-         ments could experience a dramatic setback. Mental
puter network.                                              health in the public sector is already overburdened
   The broader data from the public sector under-           and underfunded, with recent economic downturns
scores the lack of preparation for new oversight stan-      resulting in dramatic restrictions in basic services.
dards. Information from the Bazelon Center for                 It is therefore unlikely that forensic research will
Mental Health Law— emphasized by Paul Appel-                attain the standards being set by the new research
baum29 in his American Psychiatric Association              ethic. The prevailing view of mental health in general
(APA) presidential nomination address—shows the             and research in particular will exert considerable neg-
following trends: the closure of more state hospitals       ative influence on forensic research—research that
in the early 1990s than in the 20 years before; 30          already requires greater protections. Incapacity to
percent greater mental health spending in 1955 than         maintain high standards of research protection will
presently; and an overall decrease in state mental          consequently deter and impede new knowledge.

366                       The Journal of the American Academy of Psychiatry and the Law
                                                      Candilis, Arikan, Noone, et al.

   It will take the combined efforts of standard-bear-                   10. Susko MA: Researchers must ensure woman didn’t die in vain.
                                                                             Baltimore Sun. July 25, 2001, p 13A
ers at governmental and professional organizations                       11. Steinbrook R: Protecting research subjects: the crisis at Johns
(e.g., DHHS, NCQA, PRIMR, IOM, AAHRPP,                                       Hopkins. N Engl J Med 346:716 –20, 2002
APA, AAPL) to make this danger clear. The APA,                           12. Maryland House Bill 917: Human research subjects institutional
                                                                             review boards. Passed April 3, 2002
during 2002 and 2003, had already established “de-                       13. Stolberg SG: The biotech death of Jesse Gelsinger. New York
funding” as a focus of its advocacy. In the APA’s view                       Times. November 28, 1999, p 137
and that of many others, more resources are critical to                  14. Pierce C: Kennedy unbound. Boston Globe. January 5, 2003,
                                                                             p 10
the understanding of mental illness, particularly                        15. U.S. Senate: Human Research Subjects Protection Act, intro-
among those most refractory to treatment. It is these                        duced as HR 4697, May 9, 2002
vulnerable persons who are found increasingly in fo-                     16. Koski G: An open letter to the human research community.
rensic settings. To withhold necessary funds from                  
                                                                         17. National Committee on Quality Assurance: VA human research
this effort ignores the many calls to improve the re-                        protection accreditation program, final standards. Washington,
search that advances the field. Inability to keep up                         DC: NCQA, 2001
with the new oversight standards ultimately will fail                    18. Public Responsibility in Medicine and Research: Draft standards
                                                                             for human research protection programs. Boston, MA: Public
important societal obligations to research subjects,                         Responsibility In Medicine and Research, 2001
the most vulnerable and deserving contributors to                        19. Institute of Medicine: Preserving public trust: accreditation and
mental health science.                                                       human research participant protection programs. Washington,
                                                                             DC: National Academy Press, 2001
                                                                         20. Association for the Accreditation of Human Research Protection
Addendum                                                                     Programs: AAHRPP wins CDC grant to assess accreditation’s role
    Since this article went to press, Sugarman et al. have published a       in public health research. Washington, DC: AAHRPP, Septem-
letter surveying the 2002 costs of U.S. medical school IRBs. They            ber 30, 2003. Available at
                                                                         21. Brown JH, Schoenfeld LS, Allan PW: The costs of an institutional
estimate a median cost of $750,000 per year.32
                                                                             review board. J Med Educ 54:294 –99, 1979
                                                                         22. Wagner TH, Bhandari A, Chadwick GL, Nelson DK: The cost of
References                                                                   operating institutional review boards (IRBs). Acad Med 78:638 –
                                                                             44, 2003
 1. U.S. General Accounting Office: Scientific research: continued       23. Sugarman J: The role of institutional support in protecting hu-
    vigilance critical to protecting human subjects. Washington, DC:         man research subjects. Acad Med 75:687–92, 2000
    U.S. General Accounting Office, March 1996                           24. National Bioethics Advisory Commission: Ethical and policy is-
 2. U.S. Department of Health and Human Services, Inspector Gen-             sues in research involving human participants. Bethesda, MD:
    eral: Institutional review boards: a time for reform. Washington,        National Institutes of Health, August 2001
    DC: Office of the Inspector General, U.S. Dept. of Health and        25. DeVries RG, Forsberg CP: What do IRBs look like? What kind of
    Human Services, June 1998                                                support do they receive? Account Res 9:199 –216, 2002
 3. Appelbaum PS: Rethinking the conduct of psychiatric research.        26. Durham ML: How research will adapt to HIPAA: a view from
    Arch Gen Psychiatry 54:117–20, 1997                                      within the healthcare delivery system. Am J Law Med 28:491–
 4. Moreno JD: IRBs under the microscope. Kennedy Instit Ethics J            503, 2002
    8:329 –37, 1998                                                      27. O’Herrin JK, Fost N, Kudsk KA: Health Insurance Portability
 5. Institute of Medicine: Responsible research: a systems approach to       and Accountability Act (HIPAA) regulations: effect on medical
    protecting research participants. Washington, DC: National               record research. Ann Surg 239:772– 6, 2004
    Academy Press, 2002                                                  28. Ross SE, Lin CT: The effects of promoting patient access to med-
 6. Hilts PJ: New voluntary standards are proposed for experiments           ical records: a review. J Am Med Informat Assoc 10:129 –38, 2003
    on people. New York Times. September 29, 2000, p A16                 29. Appelbaum PS: Response to the presidential address: the system-
 7. Kahn JP, Mastroianni AC: Moving from compliance to con-                  atic defunding of psychiatric care—a crisis at our doorstep. Am J
    science. Arch Intern Med 161:925– 8, 2001                                Psychiatry 159:1638 – 40, 2002
 8. Office for Protection from Research Risks: Evaluation of human       30. Bazelon Center for Mental Health Law: Disintegrating systems:
    subjects: protections in schizophrenia research conducted by the         the state of the states’ public mental health systems. Washington,
    University of California Los Angeles. Washington, DC: Office for         DC: Bazelon Center for Mental Health Law, 2001
    Protection from Research Risks, National Institutes of Health,       31. Mulligan K: District branches seek solution to state’s shortage of
    May 1994                                                                 psychiatry beds. Psychiatric News. September 20, 2002, p 1
 9. Office for Protection from Research Risks: University of Mary-       32. Sugarman J, Getz K, Speckman JL, et al: The cost of Institutional
    land determination letter. Washington, DC: Office for Protection         Review Boards in academic medical centers (letter). N Engl J Med
    from Research Risks, National Institutes of Health, April 1998           352:1825–7, 2005

                                                       Volume 33, Number 3, 2005                                                           367

To top