1. The Protection of Human Participants in Research
A Brief Overview

2. Institutional Review Board
Institutional Review Board (IRB):
A campus-wide committee charged with the review of human participants research to assure adequate methods of informed consent and to
determine acceptable balance of risk/benefit.

3. Why are IRBs mandated?
Primarily for the protection of human participants in research
Human Participants Research: An
investigation which involves the collection of
data from or about living human beings.
Human Participants: Living individuals about
whom an investigator obtains data or identifiable
private information.

4. Research Abuse Examples
The Tuskegee Study, conducted from
1932 to 1972, by the Public Health Service,
examined the course of untreated syphilis in black
American men. Participants were not told they
had syphilis, nor was effective treatment offered.
The Lead Paint Study, conducted in the 1990’s,
tested the effectiveness of housing repairs in
reducing blood levels of lead in children.
Rental homes received differing levels of repairs. Landlords were asked to rent to families with
young children. Children already in the houses
remained, so their blood levels could be analyzed.

5. Some Research Risks In addition to the physical risks inherent
in bio-medical research, social and
behavioral research also may include risks
such as:
Emotional distress
Psychological Trauma
Embarrassment
Loss of employment – financial loss
Social stigmatization
Shame or guilt
Invasion of privacy
Breach of confidentiality

6. Regulations The Code of Federal Regulations (45 CFR 46)
sets “minimum standards” of ethical conduct in
human participants’ research.
Federal-Wide Assurance with OHRP assures
compliance with federal regulations and
appropriate state laws

7. Ethical Codes & Principles
The Belmont Report – April 18, 1979
Ethical Codes & Principles
identifies three basic ethical principles
Underlying the conduct of research involving
human participants:
1) Respect for persons
2) Beneficence
3) Justice
The Nuremberg Code
A set of standards developed in 1947, following
the atrocities against humans during WWII by
German researchers.
Provided the first codification of ethical
guidelines for the conduct of research involving
human participants.

8. Other Reasons for an IRB
1) It may be difficult to be objective about your own work.
2) People can underestimate the risks involved in things they are very familiar with.
3) People sometimes overestimate the benefit
of things that are important to them.

9. IRB Review Criteria for IRB Review: For submission procedures, read:
Investigator’s Handbook
Investigator’s Checklist
Satisfactory risk/benefit ratio
Equitable participant selection
Satisfactory informed consent process
Adequate privacy and confidentiality
guarantees

10. Consent Process During the consent process, investigators must be
certain that all potential participants fully
understand the information they are given, and
that all potential risks are carefully explained.
Participants must be able to understand the
information presented. Legal surrogate consent
must be obtained for those with reduced capacity.
To maintain autonomy, participation must be
freely given, without coercion or undue influence
of others.
Investigators must consider the possibility of
obtaining consent from any “third parties”
involved if personally identifiable, sensitive
information is being obtained about them.

11. Required Reading and Certification
The Belmont Report
CITI, Collaborative Institutional Training
Initiative, an on-line course required for all
IRB members and researchers
Investigator’s Guide to Human
Participants Research

12. IRB Training Who must complete the training?
All Principal Investigators and key personnel, compliance staff, institutional signatory officials, and institutional review board members
When must the training be completed?
Prior to conducting or reviewing research involving human participants.

13. Mitchell College IRB Information
Sources and Resources
1) Dedicated web page open to the public
2) Longer Power Point tutorial, on-line
3) Researcher’s Manual & appropriate web links
4) Members of the IRB and contact information

14. IRB Development Committee
Dr. Scott Horton, Behavioral Sciences
Dr. Peter Love, Academic Success Center
Dr. Kimberly Blake, Life Sciences
Dr. Julie Liefeld, Health and Wellness Center
We appreciate the support of Dr. Mary Ellen Jukoski, Dr. Gil Maffeo, and the Board of Trustees