TRAINING WORKSHOP FOR RESEARCH INVOLVING HUMAN SUBJECTS

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TRAINING WORKSHOP FOR RESEARCH INVOLVING HUMAN
SUBJECTS

• University of Oklahoma-NC
• Alberta Yadack, Director, HRPP
• Faustina Layne, QI/Education
• Human Research Participant Protection

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FEDERAL OVERSIGHT

• Office for Human Research Protections (OHRP -
  formerly Office for Protection of Research Risks,
  OPRR)
• US Department of Health and Human Services
• http//www.hhs.gov/ohrp/

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OU-NC COMPLIANCE OVERSIGHTUSE OF HUMAN SUBJECTS

• Institutional Review Board (IRB)
• Board Chair Vice Chair
• Dr. Lynn Devenport, Chair
• Dr. Laurette Taylor, Chair
• Dr. Don Baker, Vice Chair
• Dr. Aimee Franklin, Vice Chair
• Administrative Office-OHRPP
• Alberta Yadack, Director
• Faustina Layne, QI/Education Coordinator
• Suzanne Peters, IRB Administrator
• Elsa Tucker, Secretary
• Phone [phone] or irb_at_ou.edu

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IRB-NORMAN CAMPUS

• IRB Meetings, 1st Thursday and the 3rd Tuesday of
  each month (deadline for Full Board Review 10
  days prior)
• Office of Human Research Participant Protection
  (OHRPP), Evans Hall, Room 316
• Reciprocal Agreement with OUHSC
• Requires Annual Renewal

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OU Office of Human Research Participant
Protection Mission Statement

• The mission of the Office of Human Research
  Participant Protection (HRPP) is to protect the
  rights, privacy, and welfare of all human
  participants in research projects conducted by OU
  faculty, staff, and students, or otherwise
  conducted under its oversight.

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WHO MUST APPLY?

• All research involving human subjects or the use
  of data generated via human subjects research,
  which will result in publication or presentation,
  must be reviewed and approved by the OU-NC IRB
  prior to subject recruitment and data collection.
  

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RISKS

• Risks include emotional, physical, psychological,
  and sociological harms such as
• Breaches of privacy and confidentiality
• Embarrassment, harassment, stigmatization
• Damage to financial standing or employability
• Embarrassment
• Discomfort/Pain
• Criminal or civil liability

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LEVELS OF REVIEW

• Exempt-10 days
• Expedited-14 days
• Full Board-30 days

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Submission Process Timeline

• When to begin?
• When to submit to the IRB?
• How long to allow for processing by the IRB?
• How long to allow for conducting the research?
• How long to allow for data analysis?
• Closure of the study before graduation

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Items to submit

• Complete the CITI education course requirement,
  online.
• IRB application
• Protocol
• Consent form (if applicable)
• Recruitment scripts
• Recruitment advertisements
• Survey instrument and/or materials
• Letters of support from outside sources

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Items to submit

• Submit 2 copies (one original with signature and
  one copy).
• The IRB office will notify the Investigator if
  the study qualifies for Board review.
• Templates and forms are available on the website
  for you to use.

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THE IRB APPROVAL PROCESS

• Application Form found at http//www.ouhsc.edu/irb
  -norman//forms.asp
• Submit Application, Protocol and Supporting
  Documents to OHRPP
• Administrative Review
• Determination of Level of Review
• Review at required level
• Revisions, if needed, are made
• Approval Letter is Issued with IRB stamped
  consent forms

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Common Mistakes

• CITI not completed
• No signature-all personnel listed must sign
• No protocol-or not in the template
• Delete or combine sections of the consent
  template
• Missing instruments
• Missing site permission letters or other IRB
  approval letters

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Tips

• Respond promptly to IRB emails
• Missing documents, revisions, etc.
• Answer all the questions, even if N/A
• Include all documents
• Write the protocol for understanding
• Write the consent form using lay language
• Make an appointment or call the IRB for help.

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Tips

• Keep a copy of all submitted documents.
• Retain all research records until graduation
• Notify IRB study is completed
• Expedited, Full Board Continuing Review
• Exempt Letter or email
• Dont wait until the last minute to submit
• Dont change any research activity without prior
  approval from the IRB

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Accreditation

• AAHRPP Association for the Accreditation of
  Human Research Participant Protection Programs,
  Inc.
• Received accreditation September 14, 2007.

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AAHRPP

• What AAHRPP expects from organizations
• Protecting the rights and welfare of research
  participants must be an organization's first
  priority. An organization should promote a
  research environment where ethical, productive
  investigation is valued.
• Protecting research participants is the
  responsibility of everyone within an organization
  and is not limited to the Institutional Review
  Board (IRB).  Accreditation examines whether the
  policies and procedures of the organization as a
  whole result in a coherent, effective system to
  protect research participants and that all
  individuals know their roles and
  responsibilities.
• Striving to exceed the federal requirements and
  continually seeking new safeguards for protecting
  research participants while advancing scientific
  progress must be integrated into an
  organizations mission. 

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Questions?