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: cohenj@od.nih.gov

OHRP Electronic AccessOHRP Electronic Access

E-mail: ohrp@osophs.dhhs.gov

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.