unit 1 pt 4

unit 1 pt 4 - Purpose So, now we know who oversees the IRB....

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Unformatted text preview: Purpose So, now we know who oversees the IRB. oversees the IRB. Now, Now, what are the IRB’s roles roles and responsibilities? • To ensure the protection of the rights and welfare of participants in biomedical, biomedical, social, and behavioral research • To provide a peer review of human research to determine worthiness • To enhance the Principal Investigator’s outcomes 1 2 Criteria for Approval Th There are federally mandated criteria criteria that the IRB must be sure sure has been satisfied before IRB approval can be issued IRB approval can be issued. • Are risks greater than “minimal th risks*”? risks*”? • Has PI appropriately minimized those risks? • Is participant selection equitable (e.g., population inclusion or exclusion appropriate; risk of coercion minimized in recruitment)? Make sure you address each of these Make sure you address each of these issues issues in your application so that the IRB can make their determinations!! 3 Criteria for Approval (Cont) for Approval (Cont) 4 Criteria for Approval (Cont) for Approval (Cont) • Is the process for obtaining th consent appropriate? • Is there adequate monitoring of the data to ensure safety of participants? • Is informed consent appropriately documented? documented? • Have additional safeguards for participants vulnerable to coercion or undue influence been included? • Is there adequate provision for monitoring monitoring the data collection to ensure integrity of data • Is “annual” continuing review sufficient, Is annual continuing review sufficient based on risks, novelty of intervention, PI experience, etc.? PI experience, etc.? 5 6 Criteria for Approval (Cont) Criteria for Approval (Cont) IRB Review Mechanisms • Expedited: minimal risk, but person can be identified (e.g., Interview, focus group) • Do research staff/investigators have appropriate expertise to perform appropriate expertise to perform their their responsibilities in the study? • Full board: more than minimal risk or more participants are members of protected class (e.g., Experimental procedure or anything involving prisoners, children, thi women, fetuses, neonates) • Does the research setting (e.g., location of research facilities) provide provide adequate safeguards for protection of participants? 7 Minimal Risk 8 IRB Review Mechanisms Exempt: once certified by the IRB reviewer, exempt from all further IRB review (e.g., anonymous surveys, existing organization records). “The probability and magnitude of harm or discomfort to the subject anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the encountered in daily life or during the performance performance of routine physical or psychological examinations or tests.” PLEASE PLEASE NOTE: Although exempt from certain federal regulations, investigators are responsible for conducting human research responsible for conducting human research following following the ethical principles of the Belmont Report. [45 [45 CFR 46.102(i), 21 CFR 56.102(i), and/or 38 CFR 16.102(i)] 9 10 • Does the planned study address a significant Does the planned study address significant question? question? (Are we asking subjects to undergo risks associated with research that will not contribute or help the development of con th knowledge?) knowledge?) Scientific Review Review What does it mean? What can the the IRB expect? • Is the study design appropriate to answer that question? When the IRB application is submitted, hopefully the following questions have been asked and quest appropriately appropriately addressed by the principal investigator during the principal investigator during the scientific scientific review of the study: • Is the methodology adequately explained? • Are the response criteria and endpoints clearly Are identified? (What are you measuring and how are you measuring it? How will you know whether your hypothesis is true or false) whether your hypothesis is true or false) 11 12 Chairperson’s or Faculty Chairperson or Faculty Advisor’s Advisor’s Signatures What Does it mean? it • If it is a drug study, is the description of the If it is drug study is the description of the agent’s agent’s activity, dose scheduling, and dose modification criteria provided? • Is the sample size appropriate to answer the research question? (Again, are we asking individuals to undergo risks for research that may individuals to undergo risks for research that may not not provide any statistically significant information?) • We asked that the Department Chairperson (of for student research, the faculty advisor) sign each IRB application. When the IRB sees that signature, it should indicate the following: • Are the data collection and analysis methods and statistical tests described adequately? • The Department Chairperson is aware and approves the conduct of the research within the approves the conduct of the research within the department department (i.e., the research contributes to the mission and/or goals of the department). • Are the early stopping rules adequate, clearly described, and congruent with the informed consent? 13 14 IRB Applications •The Department Chairperson agrees that there are resources available (resources can include space to conduct the research, allocation of faculty time to conduct the research, or funding allocations) for the research to be conducted in allocations) for the research to be conducted, in the the manner described in the application. • For full board and expedited review complete Application for Initial Review Application • For studies that meet exemption criteria complete Exempt Certification complete Exempt Certification •The Department Chairperson acknowledges that Th Ch th the the principal investigator has the appropriate expertise and experience to conduct the research, research, in the manner described by the application. • For research activities that may not meet the the DHHS and FDA definitions of human research, complete Determination Form Determination 15 16 Basic Elements of Informed Basic Elements of Informed Consent Consen Informed Consent Issues Informed Consent must be documented documented on an IRB approved consent/assent form which bears bears the valid IRB approval stamp. stamp. • Purpose of research & research plan (I (Include a statement this makes it clear thi it the activity is research) • Identification of risks and benefits • Statement about confidentiality 17 18 Basic Elements of Informed Basic Elements of Informed Consen Consent Waivers of Informed Consent – No more than minimal risk to participants •Explanation that participation is voluntary – Waiver will not adversely affect rights/welfare of subjects •Right to refuse to participate or to withdraw after participation begins – Research could not be practically carried out without waiver •Names of person to contact with questions and concerns – Whenever possible, participants will Whenever possible, participants will subsequently subsequently be provided with additional information about study •Name of person to ask questions about research •Name of person to ask questions about rights of person to ask questions about rights 19 20 • Grant application or sponsor ’s protocol, if Grant application or sponsor protocol if funded, funded, Thesis or Dissertation, if applicable Wh What Do I Need To Submit For IRB Review? • Application for Initial Review, Exemption Certification Request (with Principal Investigator, Co-Investigator, CoDept. Dept. Chairperson and Scientific Reviewer’s signatures) (or if you believe your activities involving human participants does not meet the definition of human research, you can submit a Determination Form) • Investigator Responsibilities Certification Form and a current CV/Resume CV/R • Copy of Certificate of Completion for either USF or CITI training in human research protections training in human research protections • Study instruments (e.g., surveys, interview St guide, focus group protocol) • Letter(s) of support, if conducting study outside of USF* • Informed Consent and Research Authorization form if using Private Health Information (PHI) for each population involved or request for each population involved or a request for a waiver waiver of informed consent indicated in the application form 21 Research Proposal Process Proposal Process 22 Modification Requests • Dated stamped and logged in at the Front Desk • Revising the informed consent Revising • Entered into the Database and assigned an IRB File Number • Changing the title of the study Ch th titl th d • Reviewed by Compliance Administrator • Adding or changing a study site • Forwarded to the IRB Chair or scheduled for full IRB review • Changing or introducing an advertisement • Correspondence regarding determinations sent to PI via e-mail and letter e- • Adding or Deleting PI, Co-Investigator, or Key Personnel 23 24 Institutional Review Board Review Board How How to Access IRB Forms Division of Research Integrity & Compliance 3702 Spectrum Blvd, Suite 155 Tampa, Florida 33612 Florida 33612 www.research.usf.edu/cs/irb_forms.htm Main IRB Number 813-974-2043 MDC Box 35 Box 35 Website address: www.research.usf.edu/cs/ 25 26 ...
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