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Institutional Review Board Issues for Classroom Research

Institutional Review Board Issues for Classroom Research. Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen, IRB Chair). Definitions.

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Institutional Review Board Issues for Classroom Research

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  1. Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen, IRB Chair)

  2. Definitions • Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge • Human Subject: A living individual about whom an investigator conducting research obtains • data through the intervention or interaction with the individual • identifiable private information

  3. Why does the IRB exist? • … to protect the rights and welfare of persons recruited for participation in research • … to advance an organizational culture and infrastructure that supports the highest ethical standards in research with human participants • … to ensure compliance with federal regulations under Department of Health & Human Services Regulations (45 CFR 46)

  4. IRB Penalties • Loss of Federal Funds if found to be in violation of federal guidelines • This includes federal financial aid funding! • Shut –down of research projects at your institution

  5. Levels of Review • Convened meeting of the full IRB • Greater than minimal risk • Vulnerable population (e.g., prisoners) • Sensitive issues (e.g., substance abuse) • Expedited • No more than minimal risk & for minor changes in approved protocol • Meets one of expedited categories • Exempt • No more than minimal risk (anonymous) • Meets one of exemption categories

  6. Criteria for IRB Approval • Risks to subjects are minimized. • Risks are reasonable in relation to benefits. • Selection of subjects is equitable. • Informed consent obtained and documented. • Subjects’ safety is monitored, if appropriate. • Privacy and confidentiality of subjects is maintained. • Additional safeguards are included for vulnerable populations.

  7. Key Documents • Belmont Report – Ethical Principals and Guidelines • Title 45, Code of Federal Regulations, Part 46 (45 CFR 46) – Department of Health & Human Services • FDA Standards – for clinical trials

  8. Consent Issues • Student records are protected under FERPA • For ‘proactive” studies, obtain consent from students to access their data for the specific research purposes. List all information that will be required (GPA, other grades, high-school class standing) • For “retroactive” situations, use a “link-list” in which the identity of student is protected but the data from the class and the data needed from the Registrar can be linked • There are variations among IRBs and institutions concerning how this is done—consult with your local IRB for specifics

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