Alphabet Soup (US Federal Agencies): CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of DHHS); DHHS: Department of Health and Human Services; OHRP: Office For Human Research Protections (part of DHHS); ORI: Office of Research Integrity (part of DHHS); OIG: Office of the Inspector General
2007-09-06: OHRP Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity
The Office for Human Research Protections (OHRP), Office of Public Health and Science, is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research, as announced in Federal Register Vol. 72, No.171, page 50966-50970, dated September 5, 2007. This request for information and comments stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission entitled
Research Involving Persons With Mental Disorders That May Affect Decision-making Capacity(December 1998), and from subsequent recommendations by the National Human Research Protections Advisory Committee and the current work of the Secretary's Advisory Committee for Human Research Protections.Submit written or electronic information and comments by December 4, 2007. Written comments may be sent to REQUEST FOR INFORMATION ON RESEARCH THAT INVOLVES ADULT INDIVIDUALS WITH IMPAIRED DECISION-MAKING CAPACITY, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to impairedcapacityohrp@hhs.gov, or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request. The notice can be accessed at: http://www.hhs.gov/ohrp/documents/20070905.pdf
According to the OHRP Fact Sheet, in part:
The Office for Human Research Protections (OHRP) supports, strengthens and provides leadership to the nation's system for protecting volunteers in research that is conducted or supported by the U.S. Department of Health and Human Services (HHS).
OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections.
To carry out their research mission, nearly 10,000 universities, hospitals, and other research institutions in the U.S. and abroad have formal agreements (
assurances) with OHRP to comply with the regulations pertaining to human subject protections.Compliance
OHRP's Division of Compliance Oversight evaluates all written substantive indications of noncompliance with HHS regulations-Title 45, Part 46, Code of Federal Regulations (45 CFR part 46). OHRP asks the institution involved to investigate the allegations and to provide OHRP with a written report of its investigation. The Office then determines what, if any, regulatory action needs to be taken to protect human research subjects. (1)
OHRP uses a carrot-and-stick approach that combines education and outreach (below) with an extremely modest compliance program. It's to the great credit of OHRP that institutions, investigators, and institutional review boards have improved to the extent they have. In fact, given the mis-match between the thousands of studies enrolling millions of research subjects every year and OHRP's staff of roughly 33 employees, it's downright miraculous.
Compliance: OHRP processes Federal Wide Assurances and provides basic information about these nearly 10,000 universities, hospitals, and other research institutions
in a searchable public database. First-time users may prefer the option to search by location (= states) rather than by the name of the institution. Sometimes the everyday name of an institution is slightly different from the legal name of the entity in the database, or the name is confusingly abbreviated.
Office for Human Research Protections Database: http://ohrp.cit.nih.gov/search/asearch.asp#ASUR
What does an assurance look like? Here's an example of one:
U.S. Department of Health and Human Services (DHHS) Federalwide Assurance (FWA) for the Protection of Human Subjects For Domestic (U.S.) Institutions. FWA Number: 00002505 Version Date: 2004-06-15. North Shore-Long Island Jewish Health System Inc.
The regulation with which institutions agree to comply is:
45 CFR 46 The Common Rule Code of Federal Regulations, Title 45: Public Welfare, Department of Health and Human Services, National Institutes of Health, Office For Protection From Research Risks; Part 46: Protection of Human Subjects (13 December 2001). Available from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. (2)
An agreement with OHRP to comply with 45 CFR 46 is required in order for institutions to conduct research in human subjects with federal funds. If OHRP finds substantial non-compliance the assurance can be suspended, which turn causes suspension of all federally-funded research at the institution. Simply put, the government hopes economic self-interest will help motivate institutions to provide adequate protections for humans in research. Sometimes this doesn't work out terribly well.
The agency forwards allegations of non-compliance to institutions, and depending upon the institutions' findings and any on-site inspection, OHRP issues a determination letter describing the issues, and as needed, any necessary actions to be taken by the institution. In rare cases OHRP has suspended assurances.
OHRP determination letters are published on the agency web site shortly after being sent to the institution(s): http://www.hhs.gov/ohrp/compliance/letters/index.html
You can search the contents of OHRP determination letters with Google™, which DHHS had the foresight to install on their own servers http://www.hhs.gov/ohrp/search/
OHRP Directory / Staff Telephone Numbers and E-Mail Addresses: http://www.hhs.gov/ohrp/about/staff.html. Accessed on 2006-03-02.
To ask questions or complain about human subject research funded by the federal government or conducted under a Federal Wide Assurance:
Write To:
Kristina Borror Ph.D., Director, Division of Compliance Oversight
Office for Human Research Protections
Department of Health and Human Services
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852Phone: OHRP main telephone number (240) 453-6900
Phone: OHRP toll free number: (866) 447-4777
Fax: (240) 453-6909, (301) 402-2071
OHRP accepts complaints in writing, via email, or by telephone. OHRP also accepts anonymous complaints. In the case of signed complaints, if OHRP determines the agency has jurisdiction, they will ask whether or not they may disclose the identity of the complainant to the institution named in the allegation. For further information see:
OHRP Compliance Oversight Procedures for Evaluating Institutions. 2005-10-19. Available from http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf. Accessed on 2006-03-02.
Follow this link for CIRCARE's suggestions on raising concerns or complaining about research regulated by OHRP and FDA.
OHRP Public Outreach. (Two information leaflets aimed at research subjects and those considering enrolling in research.)
Office for Human Research Protections Home page
OHRP Human Subjects Research Decision Charts
OHRP Assurance Training Online
OHRP Institutional Review Board Guidebook
Office for Human Research Protections (OHRP) International Issues. Available from http://www.hhs.gov/ohrp/international/index.html#NatlPol
International Compilation of Human Subject Research Protections. Available from http://www.hhs.gov/ohrp/international/HSPCompilation.pdf. (A listing of the laws, regulations, and guidelines that govern human subjects research in many countries around the world.)
OHRP Index of Policy Guidance. Available from http://www.hhs.gov/ohrp/policy/index.html
OHRP Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others. 2005-10-11. Available from http://www.hhs.gov/ohrp/requests/aerg.pdf
OHRP Guidance on Institutional Review Board Review of Clinical Trial Websites. 2005-09-20. Available from http://www.hhs.gov/ohrp/policy/clinicaltrials.html
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. Department of Health and Human Services / Final Guidance Document. 2004-05-05. Available from http://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf
Report of the Equivalent Protections Working Group. 2003-07-13. Available from http://www.hhs.gov/ohrp/international/EPWGReport2003.pdf
Report of the Equivalent Protections Working Group / Appendix. Available from http://www.hhs.gov/ohrp/international/EPGWFramework.pdf
OHRP Special Protections for Children as Research Subjects (Index). Available from http://www.hhs.gov/ohrp/children/
Protections for Children in Research: A Report to Congress in Accord with Section 1003 of P.L. 106-310, Children's Health Act of 2000. Office for Human Research Protections. May, 2001. Available from http://www.hhs.gov/ohrp/reports/ohrp502.pdf
Related: Hearing on Protections for Foster Children Enrolled in Clinical Trials (Index). The Subcommittee on Human Resources of The Committee on Ways and Means, U.S. House of Representatives. 2005-05-18. Available from http://waysandmeans.house.gov/hearings.asp?formmode=detail&hearing=409&comm=2
Serial 109-8: Protections for Foster Children Enrolled in Clinical Trials. The Subcommittee on Human Resources of The Committee on Ways and Means, U.S. House of Representatives. 109th Congress / First Session. 2005-05-18. Available from http://waysandmeans.house.gov/hearings.asp?formmode=printfriendly&id=3055
HHS Survey of State Policies on the Participation of Foster Children in Clinical Trials. Available from http://waysandmeans.house.gov/media/pdf/welfare/062405hhssurvey.pdf. (Report courtesy of Senator Wally Herger.)
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 (407
) Review Process. 2005-05-26. Available from http://www.hhs.gov/ohrp/children/Guidance_407Process.pdf.
Precursor Preference in Surfactant Synthesis of Newborns / Washington University Medical Center. 2005-01-13. Available from http://www.hhs.gov/ohrp/children/surfactant.html
Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder: A Functional Magnetic Resonance Study / National Institute of Mental Health. 2004-08-15. Available from http://www.hhs.gov/ohrp/children/adhd.html. (Withdrawn.)
Characterization of Mucus and Mucins in Bronchoalveolar Lavage Fluids from Infants with Cystic Fibrosis / University of North Carolina - Chapel Hill. 2004-05-14. Available from http://www.hhs.gov/ohrp/children/mucus.html
HIV replication and thymopoiesis in adolescents / University of California at Los Angeles (UCLA). 2004-03-05. Available from http://www.hhs.gov/ohrp/children/hiv.html
Sleep Mechanisms in Children: Role of Metabolism / Yeshiva University, Albert Einstein College of Medicine, Montefiore Medical Center. 2004-03-05. Available from http://www.hhs.gov/ohrp/children/sleep.html
Alcohol, sleep and circadian rhythms in young humans, study 2: Effects of evening ingestion of alcohol on sleep, circadian phase, and performance as a function of parental history of alcohol abuse/dependence / Rhode Island Hospital. 2003-12-09. Available from http://www.hhs.gov/ohrp/children/circadian.html
Precursors to Diabetes in Japanese American Youth / University of Washington and Children's Hospital and Regional Medical Center. 2003-05-27. Available from http://www.hhs.gov/ohrp/children/japanese.html
A multi-center, randomized dose-response study of the safety, clinical and immune responses of Dryvax administered to children 2 to 5 years of age / Harbor UCLA Medical Center. 2003-01-24. Available from http://www.hhs.gov/ohrp/children/dryvax.html
Request for Public Comments: Draft Report on Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease. Secretary's Advisory Committee on Genetics, Health, and Science. Comments accepted until Monday, July 31, 2006. Available from http://www4.od.nih.gov/oba/sacghs/public_comments.htm
The Role of the HHS Office for Human Research Protections in Protecting Human Research Subjects. Schwetz BA, Director Office of Human Research Protections, U.S. Department of Health and Human Services. Testimony Before the Subcommittee on Criminal Justice, Drug Policy and Human Resources, Committee on Government Reform, United States House of Representatives. 2006-03-07. Available from http://www.hhs.gov/asl/testify/t060307.html
GAO Report Concerning Protection of Human Subjects in Medical Research at VA Facilities. Koski G. Director, Office for Human Research Protections, Office of the Secretary, U.S. Department of Health and Human Services. Testimony Before the House Committee on Veterans' Affairs, Subcommittee on Oversight and Investigations and Subcommittee on Health. 2000-09-20. Available from http://www.hhs.gov/asl/testify/t000928.html
Human Subject Research Protection. Raub WF. Deputy Assistant Secretary for Science Policy, Office of the Secretary, U.S. Department of Health and Human Services. Testimony Before the Senate Subcommittee on Public Health, Committee on Health, Education, Labor, and Pension. 2000-05-25. Available from http://www.hhs.gov/asl/testify/t000525a.html
Human Subject Research Protections. Raub WF. Deputy Assistant Secretary for Science Policy, Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Testimony Before the House Committee on Government Reform, Subcommittee on Criminal Justice. 2000-05-03. Available from http://www.hhs.gov/asl/testify/t000503a.html
Do Current Federal Regulations Protect People Who Participate in Medical Research? Lawrence AJ. Assistant Surgeon General & Deputy Assistant Secretary for Health (Operations), Office of Public Health and Science, U.S. Department of Health and Human Services. Testimony Before the House Committee on Government Reform, Subcommittee on Criminal Justice, Drug Policy and Human Resources. 1999-12-09. Available from http://www.hhs.gov/asl/testify/t991209a.html
Suspension of Medical Research at the West Los Angeles and Sepulveda VA Medical Facilities. Puglisi, JT. Director, Division of Human Subject Protections, Office for Protection from Research Risks, National Institutes of Health, U.S. Department of Health and Human Services. Testimony Before the House Committee on Veterans' Affairs, Subcommittee on Oversight and Investigations and Subcommittee on Health. 1999-04-21. Available from http://www.hhs.gov/asl/testify/t990421d.html
Medical Record Privacy. Ellis, GB. Director, Office for Protection from Research Risks, National Institutes of Health, U.S. Department of Health and Human Services. Testimony Before the Senate Committee on Health, Education, Labor, and Pension. 1999-02-24. Available from http://www.hhs.gov/asl/testify/t990224a.html
Protecting Human Clinical Research Patients. Ellis, GB. Director, Office for Protection from Research Risks, National Institutes of Health, U.S. Department of Health and Human Services. Testimony Before the House Committee on Government Reform and Oversight, Subcommittee on Human Resources. 1998-06-11. Available from http://www.hhs.gov/asl/testify/t980611a.html
Protection of Human Research Subjects. Ellis, GB. Director, Office for Protection from Research Risks, National Institutes of Health, U.S. Department of Health and Human Services. Testimony Before the Senate Committee on Governmental Affairs. 1996-03-12. Available from http://www.hhs.gov/asl/testify/t960312a.html
Belmont Report Historical Archive. Available from http://www.hhs.gov/ohrp/belmontArchive.html
Report to the Advisory Committee to the Director, NIH from the Office for Protection from Research Risks Review Panel. 1999-06-03. Available from http://www.nih.gov/about/director/060399b.htm
Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects. 1998-06-15. Available from http://www.hhs.gov/ohrp/policy/hsp_final_rpt.pdf. Accessibility verified 2006-03-02. (This is often called The Bell Report.)
Human Subject Protection and Financial Conflicts of Interest Conference August, 2000. 2000-08-15 and 16. Available from http://www.hhs.gov/ohrp/coi/index.htm
Conference on Human Subject Protection and Financial Conflicts of Interest August, 2000. Meeting Transcript. 2000-08-15. Available from http://www.hhs.gov/ohrp/coi/8-15.htm
Human Subject Protection and Financial Conflicts of Interest Conference August, 2000. Meeting Transcript. 2000-08-16. Available from http://www.hhs.gov/ohrp/coi/8-16.htm
Human Subject Protection and Financial Conflicts of Interest Conference August, 2000. Background Documents. Available from http://www.hhs.gov/ohrp/coi/refs.htm
Human Subject Protection and Financial Conflicts of Interest Conference August, 2000. Public Comment / Written Comments Received. Available from http://www.hhs.gov/ohrp/coi/comments.htm
Response of the Department of Health and Human Services to NBAC's Report Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. 2001-05-18. Available from http://aspe.hhs.gov/sp/hbm/index.htm
Analysis and Proposed Actions Regarding the NBAC Report: Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity. 2001-01-16. Available from http://aspe.hhs.gov/sp/nbac/index.shtml
Department of Health and Human Services, Assistant Secretary for Planning and Legislation. Action to Reduce Regulatory Burden. 2005-11-24. Available from http://aspe.hhs.gov/arrb/
HIPAA Information Index: Medical Privacy — National Standards to Protect the Privacy of Personal Health Information. Department of Health and Human Services Office for Civil Rights. Available from http://www.hhs.gov/ocr/hipaa/
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. National Institutes of Health. 2005-06-08. Available from http://privacyruleandresearch.nih.gov/default.asp
Notes
1. OHRP Fact Sheet. Office for Human Research Protections. 2005. Available from http://www.hhs.gov/ohrp/about/ohrpfactsheet.pdf
2. This an over-simplification. A Federal Wide Assurance to comply with 45 CFR 46 is a mandatory condition for receiving federal funds for human subject research. Institutions have the option to extend 45 CFR 46 to all research conducted at the institution or they may opt to select a different standard in non-federally funded research, for example the World Medical Association Helsinki Declaration, Ethical Principles for Medical Research Involving Human Subjects. It's estimated that about 60% of institutions choose to extend 45 CFR 46 to cover all research.
Last Updated: 2007-09-07
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