The Institutional Review Board (IRB) at UK

1. The Institutional Review Board (IRB) at UK Margaret McGladrey, MA Research Administrative Coordinator 111 Washington Ave Suite 104E Lexington, KY 40536 859.218.2023 Margaret.mcgladrey@uky.edu

2. What is the IRB and Why Do I Need to Know About it? Board responsible for monitoring protection of human subjects in research Managed by the Office of Research Integrity: http://www.research.uky.edu/ori/ Oversees all activities defined as involving “research” and “human subjects” Ensures UK’s compliance with federal human subjects protection laws and regulations

3. “Research” and “Human Subjects” • Research: “A systematic investigation designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)] • Human Subject: “A living individual about whom an investigator conducting research obtains: • Data through intervention or interaction with the individual, or • Identifiable private information”

4. Human Subjects Protection Training Required of anyone involved with data collection or analysis of research with human subjects Easiest way to meet training requirements is to do the Collaborative IRB Training Initiative (CITI) web-based training http://www.research.uky.edu/ori/human/Human_Research_Mandatory_Education.htm See handout for instructions on CITI

5. What Needs IRB Review? • Almost all research with which you will be involved! • Masters thesis or doctoral dissertations • Pilot studies • Clinical trials • Behavioral and social science research • Epidemiological research • Human genetic research • Retrospective chart reviews • http://www.research.uky.edu/ori/human/WhatNeedsIRBReview.htm

6. Which IRB and Who to Contact? All College of Public Health protocols are reviewed by the Medical IRB Exempt research contact at ORI: Joe Brown, jrbrow3@uky.edu, 859-257-9084 Expedited medical research contact at ORI: Joanne Hines, jchine2@uky.edu, 859-257-9118 Full medical research contacts at ORI: IRB #1 Amy Kolasa, akolasa@email.uky.edu, 859-257-9425 IRB #2 Jessica Roe, jaro222@uky.edu, 859-257-9118 IRB #3 Beverly Raisor, Beverly.Raisor@uky.edu, 859-257-9819 IRB #6: Suzanne Arnold, suzanne.arnold@uky.edu, 859-257-0582

7. What Type of Review? EXEMPT • Studies eligible for exemption certificate: • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular or special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.

8. What Type of Review? EXEMPT • Studies eligible for exemption certificate: • Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category (b) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. • Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Must describe data collection procedures.

9. What Type of Review? EXEMPT • Studies eligible for exemption certificate: • Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payments for benefits or services under those programs. VERY RARELY USED • Taste and food quality evaluation and consumer studies, (i) if wholesome food without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe

10. How to Apply for Exemption Certificate http://www.research.uky.edu/ori/ExemptionCertificationApplication.htm Contact: Joe Brown Core Application Form (download at URL above) Informed consent/assent process forms HIPAA forms if applicable. Studies are regulated by the UK HIPAA Privacy Rule if the investigator obtains protected health information from a UK covered entity department. See http://www.research.uky.edu/ori/HIPAA/main%20page.htm Additional study materials and disclosures of financial interests as applicable.

11. What Type of Review? EXPEDITED 1) Clinical studies of particular types of drugs and medical devices 2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from particular types of individuals 3) Prospective collection of biological specimens for research purposes by noninvasive means. (Nail clippings or hair) 4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.

12. What Type of Review? EXPEDITED 5) Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). 6) Collection of data from voice, video, digital, or image recordings made for research purposes. 7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

13. How to Apply for Expedited Review http://www.research.uky.edu/ori/MedicalExpedReviewApplication.htm Core Application forms Informed Consent/Assent process forms HIPAA forms if applicable (see Exempt review slide) Additional study materials Vulnerable Population forms Disclosure forms, if applicable. See checklist handout

14. What Type of Review? FULL Research involving greater than minimal risk to participants Clinical intervention research Research involving invasive procedures Surveys or qualitative data collection on sensitive topics or risky behaviors Most studies involving vulnerable populations: children, prisoners, pregnant women, and those with impaired capacity to consent Unlike other types of review, investigator must attend this IRB meeting

15. Completing the Forms Give yourself at least one week, assuming that you have a detailed and thorough study protocol Ask advisors and colleagues for examples of their research descriptions (Form B) and consent/assent forms as guidance Use templates for informed consent/assent documents Set up an appointment with the appropriate ORI staffer (Joe Brown, Joanne Hines) to review your complete packet before submission of forms to ORI Follow instructions re: # of copies required

16. Timelines for Review: EXEMPT One IRB member reviews materials Receive revisions or approval within 2-3 weeks of submission to ORI If revisions are required, another 2-3 weeks for approval notification. If IRB determines the study does not meet exempt criteria, then resubmission as an expedited or full review study is recommended by IRB

17. Timelines for Review: EXPEDITED Reviewed by one IRB member Receive revisions or approval within 2-3 weeks of submission to ORI If revisions are required, another 2-3 weeks for approval notification. If IRB determines the study does not meet exempt criteria, then resubmission as an expedited or full review study is recommended by IRB

18. Timelines for Review: FULL All Full Review protocols are placed on an IRB agenda and reviewed by the Full Committee at a convened meeting. Medical Full Reviews are assigned to meeting dates on a first-come first-served basis.   Investigators should receive requested revisions (sometimes approval) within 1 week after the IRB meeting. If the study requires minor revisions, the investigator can expect to wait another week after submitting the IRB's requested revisions to determine the status of their study. If the study requires major revisions, the investigator’s response will be scheduled for review at the next available convened meeting (up to four weeks). Investigators should receive the IRB’s determination within 1 week after the IRB meeting.

19. Modifications and Continuations If you need to modify your study protocol or change study personnel, you must request a modification prior to implementation. See instructions here: http://www.research.uky.edu/ori/human/IRBReviewTypes.htm#Modification If your study continues beyond one year in duration, you must have your protocol re-reviewed. See instructions here: http://www.research.uky.edu/ori/human/IRBReviewTypes.htm#CR

20. ORI Contact Information Office of Research Integrity 315 Kinkead Hall University of Kentucky Lexington, KY 40506-0057 Ph: (859) 257-9428 FAX: (859) 257-8995 Hours of Operation: 8am-12pm; 1pm-5pm Staff directory: http://www.research.uky.edu/ori/staff.htm