Institutional Review Board Privacy Board 2 Orientation Protects - PDF document

4/16/2020 man Research Protections and Quality Assurance Institutional Review Board (IRB) & Institutional Review Board Privacy Board 2 Orientation  Protects the rights and welfare of Research Participants (Human Subjects). & IRB Submission Process  Empowered to approve, require modifications, or disapprove Kevin Nellis, MS Human Research. Executive Director, Human Research Protections and Quality  Ensures Human (Subjects) Research is scientifically/scholastically Assurance valid, ethical, and in compliance with all requirements.  Ensures compliance through oversight functions.  Serves as a Privacy Board to ensure HIPAA compliance.  May conduct or request audits 1 2 Key Events Change the IRB Landscape Q1: Is it Research? (Under the Common Rule) 0 3 4  A Research Activity is BOTH:  A systematic investigation (including research 1937 1946 - 47 1950 - 60’s 1972 - 91 2010’s - 20’s development, testing, and evaluation) (i.e., activity that is Government aims Thalidomide Tuskegee Sulfanilamide Nuremberg to accelerate planned, orderly, methodical, and uses data collection to Tragedy Syphilis Elixir Incident Trials research and Study answer a question) reduce regulatory Exposé burden Drug National Food, Drug, Nuremburg 21st Century Cure’ s -AND- Amendments Research and Act (‘16) Code (‘47) added to Act (‘74) Cosmetic NIH Single IRB Rule  Designed to develop or contribute to generalizable F ,D&C Act The Belmont Act (‘38) (Effective ‘18) (‘62) Report (‘79) knowledge (i.e., knowledge gained from a study may be FDA Informed Revised Common Rule Common consent (Effective ’19) applied to populations outside of the specific study Rule (‘81) regulations Single IRB oversight (‘63) Revised CR of multi-site studies population). (‘91) (Effective ‘20) 3 4 Q2: Does it Involve Research Participants Is IRB Approval Required? (Human Subjects)? (Under the Common Rule) 5  For research to be considered human research (and thus If “YES” to requiring IRB approval before the study begins), the Q1 and Q2: research must involve living individuals about whom an YES investigator (whether professional or student) conducting Submit an IRB Q2: Does it involve research either application. Research YES  obtains information or biospecimens through Participants (human If “NO” to subjects)? intervention or interaction with the individual, and uses, Q1: Is it research? Q1 or Q2: studies, or analyzes the information or biospecimens; or NO Consult with “IRB  obtains, uses, studies, analyzes, or generates identifiable Decision Aid”, private information or identifiable biospecimens . IRB@downstate.edu or call X8480. 5 6 1

4/16/2020 Is IRB Approval Required for Is IRB Approval Required for Performance Improvement Activities? Performance Improvement Activities?  Does the activity meet the definition of research, including Example: the intent to develop or contribute to generalizable  The Emergency Department monitors their process for knowledge*? treating COVID-19 patients with the intent of improving the quality of their service and patient outcomes at Downstate.  If YES, IRB approval is required, if there is an intervention/interaction or it involves identifiable  Identifiable patient information is collected private information or identifiable biospecimens.  Without changing intent, clinic staff could  If NO, IRB approval is NOT required  Share the results at a conference * Intent to publish is an insufficient criterion for determining whether a quality improvement  Publish the results activity involves research. Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to  Recommend obtaining IRB determination letter stating IRB publish descriptions of nonresearch activities for a variety of reasons, if they believe others approval is not required. may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results. 7 8 Is IRB Approval Required for Case Reports or Case Series?  Case Reports/Series of up to three (3) individuals do not need IRB approval  Such limited activities are generally not considered to be both systematic and generalizable  Examples:  Review records of 3 patients  Review records of one patient and ask questions of 2 family members  May request an IRB Determination letter (may be required by journal or conference)  Some journals require informed consent/HIPAA Authorization 9 10 11 12 2

4/16/2020 STEP 1: Review the Downstate IRB website, policies, and guidance.  Review the Downstate IRB website for instructions and details on how to submit an IRB application.  https://research.downstate.edu/irb/electronic- submission.html  Refer to the Policy and Guidance webpage to understand Downstate Policy IRB-01 and other applicable policies and IRB guidance.  https://research.downstate.edu/irb/policies.html 13 14 STEP 2: Plan the project.  Start early!  Conduct a literature search and keep a bibliography of references to include with the protocol.  Consult with a mentor and other experts in the field, as needed.  Consult with a biostatistician, as needed.  More tips available on IRB website. 15 16 STEP 3: Identify a Principal Investigator with STEP 4: Determine whether investigators are “PI Status”. members of the Downstate workforce  Seasoned investigator with a field-specific terminal degree  Understanding whether an Investigator (or Key Personnel) is who is a Faculty Member at Downstate a member of the "Downstate workforce" will help  Clinician with clinical privileges at NYC H + H, Kings County determine:  Faculty member under recruitment to Downstate with written  IRB Training Requirements of Investigators and Key approval by a Dean Personnel & Conflict of Interest (COI) Requirements for  Individual approved to be a PI by written memo or e-mail from the Downstate Institutional Official “Investigators for the Purposes of COI,  Individual who qualifies to be a PI at an external site, when  Whether IRB Reliance Agreement(s) or Individual the research makes Downstate engaged. Downstate Investigator Agreement(s) are required, and becomes engaged when:  Which IRB to use.  Federal funding or support is provided to Downstate  Co-investigators or key personnel on the study are members of the Downstate workforce 17 18 3