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Institutional Review Board for Human Subject Research:
Does Your Research Need One?
Merle [email protected]
Michael Unsworth
OUTLINE
IRB Background
Definitions & Concepts
History – matter of ethics
IRB process
Case Studies
Definitions & ConceptsDefinitions & Concepts
Institutional Review Board (IRB)Institutional Review Board (IRB)
• A group that reviews and approves any type of research to protect the people who take part in it.
• IRBs check to see that the research is well designed, legal, ethical, does not involve unneccesary risks, and includes safeguards for people taking part.
AS DEFINED BY FEDERAL REGULATIONS
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Studies that involve interviews, follow-up contact to determine the effectiveness of a program.
Marketing surveys and surveys to assess user satisfaction often do not require IRB review and approval because contracts with member groups specifically allow members to be contacted without such approval and because these surveys do not contribute to generalizable knowledge.
If information from a project will be published in a scientific journal or presented at a scientific meeting, the project is considered research by the federal definition and requires IRB review and approval. Publication or presentation implies an intention to contribute to generalizable knowledge. Additionally, many medical journals require documentation of review by a human subjects committee as a condition of publication.
Human Subjects Research Involves
Wide variety of biomedical and clinical research
Behavioral research
Survey research
A fundamental ethical requirement in connection with research involving human subjects
A basic principle of respect for personsRespect for persons requires that
subjects, to the degree they are capable, be given the opportunity to choose what shall or shall not happen to them
Most Research Receiving Federal Funding Must Follow “The Common Rule.“(45 CFR 46) (45 CFR 46)
Elements: requirements for assuring compliance by research institutions; requirements for researchers obtaining and documenting informed consent; requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. additional protections for certain vulnerable research subjects-- pregnant women, prisoners, and children
IRBs Are the Result of 20th Century Research Misconduct or Dilemmas
The IRB Process
Title of the Study Principle Investigator ,Study Team Members (Roles,Conflict of
Interest information, & Credentials) Project Summary Estimated start and end dates Performance Site(s) and Details Research Design: Objective, Specific Aim(s)/Hypothesis,
Background Information, Interactions (e.g., information gathering, survey, interview, focus groups), Statistical Design
Benefits and Risks Subject participation (number and age) Recruitment (may include screening) Informed Consent Confidentiality/Security Retention of Data
An IRB then reviews theAn IRB then reviews the application to insure that: application to insure that:
Risks to subjects are minimized.Risks to subjects are reasonable in relation
to anticipated benefits, if any.Selection of subjects is equitable.Informed consent will be sought from each
prospective subject.The possibility of coercion or undue
influence is minimized.Require that additional information be given
to subjects “when in the IRB's judgment the information would meaningfully add to protection of the rights and welfare of subjects”.
IRBs are also responsible for ensuring that members who
review research have no conflicting interest.
Research that meets the categories set forth by the federal regulations (45 CFR 46) that expose participants to no more than minimal risk.
Research limited to the following activities may qualify for an exemption determination by an IRB:
Studying educational methods
Interviewing public figures
Use of publicly available data sets
Use of existing data and/or specimens
stripped of identifiers
HOW AN IRB DETERMINES AN EXEMPTION:
TO GET AN IRB EXEMPTION, ONE MUST STILL DO A LOT OF
PAPERWORK!
CONCLUSION:ACCEPT THE IRP PROCEDURES
AS PART OF THE RESEARCH PROCESSAND FOLLOW THEM
CASE STUDIES
