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

Dean of Graduate Studies & Research Dean of Graduate Studies & Research Dr. Peter J. Kasvinsky Dr. Peter J. Kasvinsky

““Authorized Institutional Official”Authorized Institutional Official”(Research and Compliance Officer)(Research and Compliance Officer)

Office of Grants and Sponsored Programs (OGSP)Office of Grants and Sponsored Programs (OGSP)

Ms. Cheryl Coy: Ms. Cheryl Coy: ckcoy@ysu.edu (Secretary) (Secretary)Dr. Edward Orona: Dr. Edward Orona: eorona@ysu.edu (Director) (Director)

Contact Info: Tod Hall 357, ext. 2377Contact Info: Tod Hall 357, ext. 2377

Context: OGSP ActivitiesContext: OGSP Activities

Research: grant solicitations and program announcementsResearch: grant solicitations and program announcements Grant/contract development: editing and budget assistance Grant/contract development: editing and budget assistance Proposal preparation and submissionProposal preparation and submission Agency and foundation contacts and visitsAgency and foundation contacts and visits Grant recording FY 04 (152 proposal submissions)Grant recording FY 04 (152 proposal submissions)

($18 requested; received > $5.8M / year)($18 requested; received > $5.8M / year) Compliance, stewardship and progress reportsCompliance, stewardship and progress reports Committees Committees : Human and Animal Subjects: Human and Animal Subjects

Human Subjects Research ComitteeHuman Subjects Research Comittee

““Planning and Clearance”Planning and Clearance”

Faculty and Students as Principal Investigators (PIs)Faculty and Students as Principal Investigators (PIs)Involvement of HSRC and Compliance OfficerInvolvement of HSRC and Compliance Officer

Human Ss Research: Authorization pre-approvalHuman Ss Research: Authorization pre-approvalYSU Policies: “Red Guidebook” on the webYSU Policies: “Red Guidebook” on the webBoard of Trustees (BOT) Policy #1014.01.Board of Trustees (BOT) Policy #1014.01.

Human Subjects Research CommitteeHuman Subjects Research Committee

YSU BOT Policy #1014.01YSU BOT Policy #1014.01““Integrity in Research – Use of Human Participants”Integrity in Research – Use of Human Participants”

"The University "The University conducts research with integrity requiring the protection of conducts research with integrity requiring the protection of the rights, well-being, and personal privacythe rights, well-being, and personal privacy of all persons utilized as of all persons utilized as participants. The University is responsible for the development of participants. The University is responsible for the development of procedures that are in conformance with, but not limited to, relevant procedures that are in conformance with, but not limited to, relevant federal and state regulations. All research conducted under University federal and state regulations. All research conducted under University auspices that involves human subjects shall fall under the purview of auspices that involves human subjects shall fall under the purview of this policy and its procedures." this policy and its procedures."

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.

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 ResearchHuman Subjects Research

Brief History of Human Ss Protection (view tape)Brief History of Human Ss Protection (view tape)

World War II crime trials of 1946 and Nuremberg Code (ethics guide)World War II crime trials of 1946 and Nuremberg Code (ethics guide)NIH in 1953 adopts formal research review by scientistsNIH in 1953 adopts formal research review by scientistsThalidomide expts in early 1960s: FDA changes (informed consent)Thalidomide expts in early 1960s: FDA changes (informed consent)Tuskegee - research on untreated syphilis in black men (1972)Tuskegee - research on untreated syphilis in black men (1972)1974: Congress passes National Research Act – to create IRBs …1974: Congress passes National Research Act – to create IRBs …and to create: National Commission for the Protection of Human and to create: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Subjects of Biomedical and Behavioral Research Commission issues Belmont Report (1978): ethical principlesCommission issues Belmont Report (1978): ethical principles

Continuing compliance problems: Havasupai $25M lawsuit against Continuing compliance problems: Havasupai $25M lawsuit against Arizona State University ( 3/6/04). Arizona State University ( 3/6/04).

Belmont ReportBelmont Report

3 “Basic Ethical Principles and Their Application”3 “Basic Ethical Principles and Their Application”

(1) Respect for Persons – as autonomous agents (can make choice)(1) Respect for Persons – as autonomous agents (can make choice)– Elements of Informed ConsentElements of Informed Consent

A) Information A) Information B) Comprehension (by protected populations)B) Comprehension (by protected populations)C) Voluntarism – no coercion or fear of reprisalC) Voluntarism – no coercion or fear of reprisal

(2) Beneficience – assessment of the nature of risk(2) Beneficience – assessment of the nature of risk– Potential benefits of research should outweigh potential risks.Potential benefits of research should outweigh potential risks.

(3) Justice – in sharing risks.(3) Justice – in sharing risks.– Reasonable selection of human subjectsReasonable selection of human subjects

Human Subjects Research CommitteeHuman Subjects Research Committee Types of Protocols: Submission Forms (120+/yr)Types of Protocols: Submission Forms (120+/yr)

Exempt ProtocolExempt Protocol: : Used when the research is exempt from Human Subjects Used when the research is exempt from Human Subjects

Full Committee Review.Full Committee Review.Six Categories of Exemption (federally-approved):Six Categories of Exemption (federally-approved):

(See protocol form for Definitions.)(See protocol form for Definitions.)

Full Committee ReviewFull Committee Review: : This form is used when the exemptions above do NOT This form is used when the exemptions above do NOT apply. Reviewed only at the Full Committee meetings.apply. Reviewed only at the Full Committee meetings.

““Update” and “Modification of Protocol” FormsUpdate” and “Modification of Protocol” Forms Continuing review of multi-year projects Continuing review of multi-year projects (occasional use only)(occasional use only)

Human Subjects Research: Protocol FormsHuman Subjects Research: Protocol Forms Exempt Protocol Form (short form)Exempt Protocol Form (short form)

Exempt ProtocolExempt Protocol: Six Categories of Exemption: Six Categories of Exemption

Example: (Exemption #1) Example: (Exemption #1) ““Research conducted in established or commonly-accepted educational Research conducted in established or commonly-accepted educational settings involving normal educational practices, such as: settings involving normal educational practices, such as: (a) research on regular and special education instructional strategies; (a) research on regular and special education instructional strategies; (b) research on the effectiveness of or the comparison among (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.”instructional techniques, curricula, or classroom management methods.”

Attach copy of Informed Consent Form, etc. Complete form and sign.Attach copy of Informed Consent Form, etc. Complete form and sign.

Time Line: Reviewed by HSRC Chair anytime.Time Line: Reviewed by HSRC Chair anytime.Allow about 2-3 weeks (based on person’s availability).Allow about 2-3 weeks (based on person’s availability).

Human Subjects Research: Protocol FormsHuman Subjects Research: Protocol Forms Full Committee Review Form (long form)Full Committee Review Form (long form)

When cannot use Exempt ProtocolWhen cannot use Exempt Protocol: Six Categories of Exemption: Six Categories of ExemptionFull Committee ReviewFull Committee Review: The exemptions above do NOT apply when:: The exemptions above do NOT apply when:a)a) Deception of subjects may be an element of research;Deception of subjects may be an element of research;b)b) Subjects are under the age of 18;Subjects are under the age of 18;c)c) Activity may expose the subject to discomfort or harassment Activity may expose the subject to discomfort or harassment

beyond levels encountered in daily life;beyond levels encountered in daily life;d)d) When the subjects are: fetuses, pregnant women, … or When the subjects are: fetuses, pregnant women, … or

incarcerated individuals. incarcerated individuals.

Complete long form and sign.Complete long form and sign.

Time Line: Reviewed by Full HSRC Committee. Time Line: Reviewed by Full HSRC Committee. Committee meets only monthly.Committee meets only monthly.Based on availability (scheduled meeting).Based on availability (scheduled meeting).Allow about 1-2 months.Allow about 1-2 months.

Elements of Informed ConsentElements of Informed ConsentTitle 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 WebsitesHuman Ss Research: Useful Websites

Office for Human Research ProtectionsOffice for Human Research Protectionshttp://ohrp.osophs.dhhs.gov/http://ohrp.osophs.dhhs.gov/

Dept. of Health & Human Services/Dept. of Health & Human Services/Office of Civil RightsOffice of Civil Rights

http://www.hhs.gov/ocr/http://www.hhs.gov/ocr/

National Institutes of Health/National Institutes of Health/Office of Human Subjects ResearchOffice of Human Subjects Research

http://ohsr.od.nih.govhttp://ohsr.od.nih.gov

Announcements: for FallAnnouncements: for Fall

Web Site for OGSP (link from Graduate Studies)Web Site for OGSP (link from Graduate Studies) Go to: Academic Depts > Grad.Studies > OGSPGo to: Academic Depts > Grad.Studies > OGSP http://www.ysu.edu/OGSP http://www.ysu.edu/OGSP

HRSC is updating “procedures”; training sessions. HRSC is updating “procedures”; training sessions. Updated Human Ss Protocol forms Updated Human Ss Protocol forms (Exempt & Full Comm. Review)(Exempt & Full Comm. Review)Available as Word and PDF documentsAvailable as Word and PDF documentsiPDF Forms (interactive): complete and printiPDF Forms (interactive): complete and printForms: templates & examplesForms: templates & examplesChanging federal laws (HIPAA)Changing federal laws (HIPAA)

- medical and privacy issues- medical and privacy issues