Human Subjects Protections

Human Subjects Protection History
Nuremberg Code (1946)
Human Subjects Protection History
Declaration of Helsinki (1964)
Human Subjects Protection History
National Commission for the Protection of Research Subjects in Biomedical and Social Behavioral Research (1974) formed to set up regulations
Human Subjects Protection History
Belmont Report (1979)
• Respect for persons
• Beneficence
• Justice
Regulatory requirements
• Federal
• 45 CFR 46 – DHHS Policy for Protection of Human Subjects – Subpart A = the “Common Rule”
• Heavily influenced by the Belmont Report
• Adopted by 15 Federal departments and agencies
Subpart B – D = Additional protections for vulnerable populations
21 CFR 50 – FDA Protection of Human Subjects = requirements for clinical investigations regulated by the FDA
Code of Virginia (32.1-162.16
HHS – Department of Health and Human Services
OHRP – Office of Human Research Protection
FDA – Food and Drug Administration
Institutional Requirements
Because we accept funding from federal agencies we have a Federalwide Assurance (FWA) – we must also comply with Virginia Code The institution is responsible for reviewing all human subjects research through use of and support for an Institutional Review Board (IRB). The institution is also responsible for ensuring compliance with all requirements in our FWA and the regulations and providing educatio
Human Subjects Review
The IRB Reviews Human Subjects Research as Defined by the Regulations
Step 1: Is it Research?
What is Research?
A systematic investigation designed to develop or contribute to generalizable knowledge (includes research development, testing, and evaluation)
•This include biomedical, social, and behavioral research
Step 2: Does the Research Involve Human Subjects?
Human Subject = a living individual about whom an investigator conducting research obtains
• data through intervention or interaction with the individual, or
• identifiable private information
IRB Review
The IRB only reviews projects that meet the definitions of BOTH research and human subjects The IRB is a peer review board consisting of at least 5 members of varying backgrounds who:
• Are sufficiently qualified
• Are not solely from one profession
• Are diverse Additional IRB composition requirements:
• At lease one non-scientist
• At least one non-affiliated member
• Expertise on vulnerable populations
• Outside consultants when needed
Means that the IRB does not have to review (exempt under 45 CFR 46); does not mean that subjects shouldn’t have protections
Must be determined by someone other than the investigator
IRB Review
• Reviewed by one or more IRB member outside of committee meeting.
• Must fit in one of 9 categories
IRB Review
• Reviewed at full board Must review annually or more frequently Disapprovals are only allowed at full board meetings
IRB Responsibilities
Review and approve, require modifications, or disapprove all covered research
Review informed consent practices and ensure compliance with regulations
Notify investigators of concerns, questions, and decisions
Conduct yearly (or more frequent) review of ongoing covered research
IRB Approval
In order to approve a project the following must be met:
• Risks to subjects are minimized
• Risks are reasonable in relation to anticipated benefits
• Selection of subjects is equitable
• Informed consent is sought from each subject
• Informed consent is appropriately documented In Addition – for certain projects:
• Data collection is monitored to ensure subject safety
• Privacy and confidentiality is protected
• Additional safeguards are included for vulnerable populations
Special Protections for Vulnerable Populations
Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates involved in Research Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D: Additional Protections for Children Involved as Subjects in Research
Substantive Informed Consent
Consent is a PROCESS – not a document
Subject recruitment is part of the consent process
• Advertisements and other methods should be consistent with protocol
• Recruitment should not be coercive or make unfounded claims
• It should be clear from recruitment materials that Research is involved
Substantive Informed Consent
Research participant is legally and mentally able to give consent or has a representative,
They are given sufficient time to consider participation and ask questions,
Coercion/undue influence is minimized,
The language is appropriate for the population and understandable to the individual subject
No exculpatory language – language in which the subject is made to waive or appear to waive legal rights OR releases or appears to release researchers from liability for negligence
Substantive Informed Consent
It should include a full discussion and disclosure of:
• the nature of the research,
• any risks and benefits,
• subjects involvement is voluntary and they may withdraw from the study at any time, Risks should be explained in the context of recognizable experiences
Documentation of Informed Consent
Documentation may be waived when:
• (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
• (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Waiver or Alteration of Consent
Government Program Evaluations
• The study is an evaluation of a public program of services, is subject to governmental approval, and is evaluating procedures for obtaining benefits, changes in the program, or methods or levels of payment to be made under the program, AND
• The research cannot practicably be carried out without the waiver or alteration. Other Research
• The research involves no more than minimal risk,
• The waiver or alteration will not adversely affect the rights and welfare of the subject,
• The research cannot practicably be carried out without the waiver or alteration; AND
• The subjects will be provided with additional pertinent information, if appropriate, after participation.