Human Subjects Research Committee (HSRC) (or, Institutional Review Board)

1. 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: ckcoy@ysu.edu (Secretary) Dr. Edward Orona: eorona@ysu.edu (Director) Contact Info: Tod Hall 357, ext. 2377

2. 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

3. 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.

4. 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." 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.

5. 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)

6. 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).

7. 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

8. 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 Committee

9. 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

10. 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: Deception of subjects may be an element of research; Subjects are under the age of 18; Activity may expose the subject to discomfort or harassment beyond levels encountered in daily life; 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. Human Subjects Research: Protocol Forms

11. 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)

12. 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

13. 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