Presentation on theme: "Human Subjects Protections, Concepts, and Procedures Office of Research and Sponsored Programs Tom Lombardo, Ph.D., Director, Research Integrity & Compliance."— Presentation transcript:
Human Subjects Protections, Concepts, and Procedures Office of Research and Sponsored Programs Tom Lombardo, Ph.D., Director, Research Integrity & Compliance & Jennifer Caldwell, Ph.D. Research Compliance Specialist March Barr Hall,
What is the IRB and why do I need to know about it? Office of Research and Sponsored Programs IRB = Institutional Review Board It is University policy AND State & Federal law that “All human research… must be reviewed and approved before the research begins.”
Why do we need regulations? Willowbrook (1950s) San Antonio Birth Control Study (1970) Tuskegee Syphilis Study ( )
“But this doesn’t apply to me: I’m just doing a survey” University of VA – all human subject research shut down – because of a survey study. Parent of research participant sued UVA over a survey on medical problems of family members [violation of his rights] $3M cost to fix everything Office of Research and Sponsored Programs
What counts as “research?” Office of Research and Sponsored Programs “A systematic investigation designed to develop or contribute to generalizable knowledge.” Includes pilot studies Excludes assessments of quality control and teaching, DM polls, etc.
Who is a “research subject?” Office of Research and Sponsored Programs ‘A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual OR identifiable, private information’ (human data or tissue) Excludes de-identified secondary data sets
Belmont Report Basic Ethical Principles Respect for Persons Tell subjects who, what, why Get Consent – signed or implicit Beneficence Maximize benefits and minimize harms or risks Justice “Spread” the risks/benefits – justify excluding any group (whites, females, etc.)
IRB: Gatekeeper of the Belmont Principles Office of Research and Sponsored Programs “Investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others who are independent of the research must share this responsibility” National Commission on Institutional Review Boards, 1978
Primary Goals of the IRB Office of Research and Sponsored Programs IRB is a resource to assist researchers’ compliance with Federal Regulations. (not a paperwork police force) IRB’s success is measured by the degree to which researchers’ habits are driven by ethical principles, not by meeting regulations.
INFORMED CONSENT Office of Research and Sponsored Programs Decision-Making Competence Consent / Assent Disclose information What would a reasonable person want to know before agreeing to participate? Comprehension: 6th grade reading level
What are the Elements of Consent? Office of Research and Sponsored Programs This is a Research Study. It’s Purpose is… It will take you  minutes In the study, you will… Study Risks and benefits are… Researcher and IRB Contact info Your Participation is voluntary; you can quit any time Could be signed consent, information sheet, oral
Levels of IRB Review Office of Research and Sponsored Programs Exempt (Administrative) Form: Screening / Abbreviated Application Review: IRB Research Compliance Specialist Education: Brief UM Online reading/quiz Expedited (Designated) Form: Full Application Review: IRB Chair or Board Member(s) Education: Full CITI online courses Full Board Review Convened Meeting of Board
Training Office of Research and Sponsored Programs Ensure that all personnel who will be involved in your study have completed whatever training they need! Information on training can be found on our website at: research.olemiss.edu/irb/education IRB will not even read your application until you complete the required level of training for your project!
Exempt Research Office of Research and Sponsored Programs Most survey research with adults Anonymous or innocuous Research on educational practices – adults or children Existing data or records that cannot be tied to Ss Does not require signed consent forms
Expedited Research Office of Research and Sponsored Programs Research activities that 1) Present no more than minimal risk to Ss and 2) Involve only specific procedures listed in the federal regulations “A risk is minimal where the probability & magnitude of harm or discomfort anticipated …. are not greater …. than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”
Full Board Review Office of Research and Sponsored Programs Examples: Child studies with manipulations DXA > Moderate exercise Deception Treatment studies Some survey studies (e.g., bullying) Monthly meeting dates posted on website Submissions must be received 2 weeks in advance
SURVEYS Office of Research and Sponsored Programs Include all elements of consent For online surveys: add a ‘Click here if you agree’ button Must allow Ss to omit items Cannot penalize for failure to complete Qualtrics: research.olemiss.edu/resources/surveys
Tips to Save Time Office of Research and Sponsored Programs Most recent form: Get all forms directly from the website at research.olemiss.edu/irb/protocol Make sure to include ALL needed attachments Appendices Survey or Interview Questions Permission letters from off-campus locations Information sheet or consent form Recruitment , flyer, or script Double check that you have thoroughly answered each question on the application!