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

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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_at_ysu.edu (Secretary)
• Dr. Edward Orona eorona_at_ysu.edu (Director)
• Contact Info Tod Hall 357, ext. 2377

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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 gt 5.8M / year)
• Compliance, stewardship and progress reports
• Committees Human and Animal Subjects

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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.

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Human Subjects Research Committee
The Human Subjects Research Committee (HSRC) is
the YSU Institutional Review Board (IRB). The
Committees 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."

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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)
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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).

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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

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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)

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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 persons
  availability).

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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
• 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.

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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)
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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

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Announcements for Fall

• Web Site for OGSP (link from Graduate Studies)
• Go to Academic Depts gt Grad.Studies gt 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