Transcript IRB.Training Workshop - Youngstown State University

Human Subjects Research Committee (HSRC)
(or, Institutional Review Board)
Dean of Graduate Studies & Research
Dr. Peter J. Kasvinsky
“Authorized Institutional Official”
(Research and Compliance Officer)
Office of Grants and Sponsored Programs (OGSP)
Ms. Cheryl Coy: [email protected] (Secretary)
Dr. Edward Orona: [email protected] (Director)
Contact Info: Tod Hall 357, ext. 2377
Context: OGSP Activities
Research: grant solicitations and program announcements
Grant/contract development: editing and budget assistance
Proposal preparation and submission
Agency and foundation contacts and visits
Grant recording FY 04 (152 proposal submissions)
($18 requested; received > $5.8M / year)
Compliance, stewardship and progress reports
Committees : Human and Animal Subjects
Human Subjects Research Comittee
“Planning and Clearance”
Faculty and Students as Principal Investigators (PIs)
Involvement of HSRC and Compliance Officer
Human Ss Research: Authorization pre-approval
YSU Policies: “Red Guidebook” on the web
Board of Trustees (BOT) Policy #1014.01.
Human Subjects Research Committee
The Human Subjects Research Committee (HSRC) is the YSU Institutional
Review Board (IRB). The Committee’s purpose is to review and approve the
adequacy of human subjects protection. The Committee is comprised both
of scientist and non-scientists.
YSU BOT Policy #1014.01
“Integrity in Research – Use of Human Participants”
"The University conducts research with integrity requiring the protection
of the rights, well-being, and personal privacy of all persons utilized as
participants. The University is responsible for the development of
procedures that are in conformance with, but not limited to, relevant
federal and state regulations. All research conducted under University
auspices that involves human subjects shall fall under the purview of
this policy and its procedures."
DEFINITIONS ACCORDING TO
CODE OF FEDERAL REGULATIONS
DEFINITION OF “RESEARCH”
“Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge.”
45 CFR 46.102 (d) (Title 45, Code of Fed. Regulations, Part 46)
DEFINITION OF “HUMAN SUBJECT”
“Human subject means a living individual about whom an investigator
(whether professional or student) conducting research obtains:
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.”
45 CFR 46.102 (f)
Human Subjects Research
Brief History of Human Ss Protection (view tape)
World War II crime trials of 1946 and Nuremberg Code (ethics guide)
NIH in 1953 adopts formal research review by scientists
Thalidomide expts in early 1960s: FDA changes (informed consent)
Tuskegee - research on untreated syphilis in black men (1972)
1974: Congress passes National Research Act – to create IRBs …
and to create: National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
Commission issues Belmont Report (1978): ethical principles
Continuing compliance problems: Havasupai $25M lawsuit against
Arizona State University ( 3/6/04).
Belmont Report
3 “Basic Ethical Principles and Their Application”
(1) Respect for Persons – as autonomous agents (can make choice)
– Elements of Informed Consent
A) Information
B) Comprehension (by protected populations)
C) Voluntarism – no coercion or fear of reprisal
(2) Beneficience – assessment of the nature of risk
– Potential benefits of research should outweigh potential risks.
(3) Justice – in sharing risks.
– Reasonable selection of human subjects
Human Subjects Research Committee
Types of Protocols: Submission Forms (120+/yr)
Exempt Protocol:
Used when the research is exempt from Human Subjects
Full Committee Review.
Six Categories of Exemption (federally-approved):
(See protocol form for Definitions.)
Full Committee Review:
This form is used when the exemptions above do NOT
apply. Reviewed only at the Full Committee meetings.
“Update” and “Modification of Protocol” Forms
Continuing review of multi-year projects
(occasional use only)
Human Subjects Research: Protocol Forms
Exempt Protocol Form (short form)
Exempt Protocol: Six Categories of Exemption
Example: (Exemption #1)
“Research conducted in established or commonly-accepted educational
settings involving normal educational practices, such as:
(a) research on regular and special education instructional strategies;
(b) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management
methods.”
Attach copy of Informed Consent Form, etc. Complete form and sign.
Time Line: Reviewed by HSRC Chair anytime.
Allow about 2-3 weeks (based on person’s availability).
Human Subjects Research: Protocol Forms
Full Committee Review Form (long form)
When cannot use Exempt Protocol: Six Categories of Exemption
Full Committee Review: The exemptions above do NOT apply when:
a) Deception of subjects may be an element of research;
b) Subjects are under the age of 18;
c) Activity may expose the subject to discomfort or harassment
beyond levels encountered in daily life;
d) When the subjects are: fetuses, pregnant women, … or
incarcerated individuals.
Complete long form and sign.
Time Line: Reviewed by Full HSRC Committee.
Committee meets only monthly.
Based on availability (scheduled meeting).
Allow about 1-2 months.
Elements of Informed Consent
Title 45 Code of Federal Regulations Part 46
§46.116 GENERAL REQUIREMENTS FOR INFORMED CONSENT
HRSC Committee recommends these elements:
1. Statement of purpose of the study.
2. Short description of methodology and duration of participant involvement.
3. Statement of risks/benefits to the participants.
4. Statement of data confidentiality.
5. Statement regarding the right of the participant to withdraw from the study at any
time without negative consequences.
6. An offer to answer any questions the participant may have.
7. Name, title, address, and phone number of all principal investigators.
8. Signature line for participants or parents or legal guardian (except for
questionnaire research where questionnaire return is implied consent).
9. Statement that participant is 18 years of age or older unless parent or legal
guardian has given consent.
(Assent v. consent)
Human Ss Research: Useful Websites
Office for Human Research Protections
http://ohrp.osophs.dhhs.gov/
Dept. of Health & Human Services/
Office of Civil Rights
http://www.hhs.gov/ocr/
National Institutes of Health/
Office of Human Subjects Research
http://ohsr.od.nih.gov
Announcements: for Fall
Web Site for OGSP (link from Graduate Studies)
Go to: Academic Depts > Grad.Studies > OGSP
http://www.ysu.edu/OGSP
HRSC is updating “procedures”; training sessions.
Updated Human Ss Protocol forms
(Exempt & Full Comm. Review)
Available as Word and PDF documents
iPDF Forms (interactive): complete and print
Forms: templates & examples
Changing federal laws (HIPAA)
- medical and privacy issues