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Office for Human Research Office for Human Research Protections (OHRP)Protections (OHRP)
Department of Health and
Human Services
Office of Public Health and Science
Director: Greg Koski, Ph.D. M.D.
Office for Human Research Office for Human Research Protections (OHRP)Protections (OHRP)
Dr. Jeffrey CohenAssociate Director for Education
Phone: (301) 402-5552 Fax: (301) 402-2071E-mail: [email protected]
OHRP Electronic AccessOHRP Electronic Access
E-mail: [email protected]
Web Site: http://ohrp.osophs.dhhs.gov
Ethical PrinciplesEthical Principles
The Belmont ReportThe Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
April 18, 1979
The Belmont ReportThe Belmont Report
Respect for Persons– Individual autonomy– Protection of individuals with reduced autonomy
Beneficence– Maximize benefits and minimize harms
Justice– Equitable distribution of research costs and
benefits
Basic Ethical Principals:
Federal RegulationsFederal Regulations
Federal Regulations and PolicyFederal Regulations and Policy
45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects Originally adopted May, 1974, Revised January 13, 1981, Revised June 18, 1991Additional protections for vulnerable populations
in Subparts B-D
Federal Policy for the Protection of Human Subjects - “The Common Rule” June 18, 1991Departments of Agriculture, Energy, Commerce, HUD, Justice,
Defense, Education, Veterans Affairs, Transportation, and HHS. NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.
Federal Regulations and PolicyFederal Regulations and Policy
Additional Protections Included in 45 CFR 46: Subpart B - Additional DHHS Protections Pertaining
to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization
Subpart C - Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Subpart D - Additional DHHS Protections for
Children Involved as Subjects in Research
DefinitionsDefinitions Research - a systematic investigation
designed to develop or contribute to generalizable knowledge.
Human Subject - a living individual about whom an investigator conducting research obtains– data through intervention or interaction with
the individual, or– identifiable private information
Basic ProtectionsBasic Protections
The regulations contain three basic protections for human subjects:
Institutional Assurances IRB Review Informed Consent
Institutional Institutional AssurancesAssurances
Institutional ResponsibilitiesInstitutional Responsibilities
Institutions bear full responsibility for all research involving human subjects covered under their Assurance
All requirements of 45 CFR 46 must be met for all federally-sponsored research
OHRP strongly encourages institutions to embrace the HHS regulations regardless of sponsorship, and to commit to this standard in their Assurance.
Institutional ResponsibilitiesInstitutional Responsibilities
Designate one or more Institutional Review Boards (IRBs) to review and approve all nonexempt research covered by an the Assurance
Provide sufficient space and staff to support the IRB’s review and record-keeping duties
Establish education and oversight mechanism
Institutional Review Institutional Review Board ReviewBoard Review
IRB Decision MatrixIRB Decision Matrix
BENEFICENCE JUSTICE
RESPECT FOR PERSONS
Protection of subjects (especially vulnerable
populations)
Informed consentSurrogate consent
Assent
Risk/Benefit AnalysisExperimental DesignQualifications of PI
Subject selectionInclusion/exclusion
Recruitment
J. Cooper, Albany Medical Center
Social & Psychological RiskSocial & Psychological Risk
Social & Social & Psychological Psychological risks are real risks are real
risksrisks
Social & Psychological RiskSocial & Psychological Risk
Examples – Emotional Distress– Psychological Trauma– Invasion of Privacy– Embarrassment– Loss of Social Status– Loss of Employment
Social & Psychological RiskSocial & Psychological Risk
Risks are TIME and SITUATION specific
Psychological & social risks are very subjective
There is little or no empirical data on the likelihood of risk in behavioral or social research
Social & Psychological RiskSocial & Psychological Risk
In some cases simply participating in the research can cause social or psychological harm– psychological reaction to situation– psychological reaction to questions
Social & Psychological RiskSocial & Psychological Risk
Primary source of social risk results from a breach of confidentiality.– Confidentiality and anonymity are not the
same– Names are not the only identifiers– Subjects’ participation in the research may
need to be kept confidential as well as their data
Informed ConsentInformed ConsentBeyond the Beyond the
Consent Consent FormForm
The Consent ProcessThe Consent Process
Informed consent is not a single event or just a form to be signed -- rather, it is an educational process that takes place between the investigator and the prospective subject.
The basic elements of the consent process include: full disclosure of the nature of the research and the
subject's participation, adequate comprehension on the part of the potential
subjects, and the subject's voluntary choice to participate.
Consent vs. Consent FormsConsent vs. Consent Forms
The consent form is merely the documentation of informed consent and does not, in and of itself, constitute informed consent.
Informed consent is a process which is documented by a signed consent form.
The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent.
ComprehensionComprehension
Informed consent is not valid unless the consentor understands the information that has been provided.
It is the responsibility of the investigator to do what he/she can to enhance each prospective subject's comprehension of the information.
Tampa Tribune 3/11/00Tampa Tribune 3/11/00
TAMPA - A lawsuit accusing USF doctors of experimenting on pregnant women without their consent is settled for $3.8 million…. The experiment wasn't considered risky and no adverse effects were documented, plaintiffs in the suit agree. However, the failure to inform … as many as 3,000 ... pregnant women of various experiments conducted between 1986 and 1990 has cost Tampa General Hospital, USF and the state $3.8 million.
Compliance ConcernsCompliance Concerns
OPRR Compliance Activities: Common Findings and
Guidance
http://ohrp.osophs.dhhs.gov/references/findings.pdf
Does the institution support and respect the IRB and its mission?
Is there a “culture of compliance”?Are IRB members and investigators
knowledgeable about regulatory requirements?
Is there adequate documentation of IRB findings and actions?
OHRP/FDA/VA WorkshopsOHRP/FDA/VA Workshops
"Current Human Research Issues & Solutions: Regulatory Overview & Investigator/Institutional Sponsor Partnerships ", May 10-11, 2001, Newark, NJ.
"Current Human Research Issues & Solutions: Regulatory Overview & Hot Topics", June 21-22, 2001, Charleston, SC
"Current Human Research Issues & Solutions: Regulatory Overview & Social/Behavioral Research" July 16-17, 2001, Los Angeles, CA.
"Current Human Research Issues & Solutions: Regulatory Overview & TBD", September 20-21, 2001, Minneapolis, MN.