Division of General Internal Medicine Streamlining IRB Submissions: Tricks and Tips for the Busy Faculty Member Amanda Bertram, MS Research Associate Division of General Internal Medicine Amanda Bertram, MS

Disclosures None Amanda Bertram, MS

I know this is how must feel when they even think about having to submit and IRB or do “scholarly work” Amanda Bertram, MS

Objectives Feel more comfortable submitting a proposal to the IRB Overcome some “tricky” aspects of an IRB submission Define some terminology Amanda Bertram, MS

Q1: When do I need to submit to the IRB? Not all projects need IRB approval QI does not Manuscripts must say QI – cannot call project research However, always best to submit or ask DO submit any work that can be considered a study QI can be published without submission but MUST be referred to as QI (cannot say research) Recommend ALWAYS submitting, just to be safe. In case something you think is QI, is not. Amanda Bertram, MS

Amanda Bertram, MS

Q2: What type of IRB submission? Quality Improvement Intent is not to generate scientific knowledge Not Human Subjects Research Does NOT involve interaction with living individuals or obtain identifiable information NHSR/QI – data collection is anonymous, project is QI/QA (would happen regardless of data collection) Amanda Bertram, MS

Q2. What type of IRB submission? Exempt Minimal risk, or no risk at all  Expedited No more than minimal risk  Exempt – IRB reviews but does not need ongoing IRB review or approval; generally when data collection is anonymous Expedited – generally when you are obtaining identifying information (even if de-identified) Amanda Bertram, MS

Exempt Expedited Amanda Bertram, MS

Q2. What type of IRB submission? Convened (“Full submission”) More than minimal risk Involving certain vulnerable populations Convened – generally for more than minimal risk trials; generally clinical trials, studies involving medication or devices; also some vulnerable populations (can require extra steps and procedures to make sure they are not being taken advantage of) Amanda Bertram, MS

Amanda Bertram, MS

Q3: Who’s name gets put on an IRB? Anybody who is engaged in human subjects research For manuscripts: Author does not necessarily have to be on IRB submission Not all on IRB submission must be authors Engaged in human subjects research = interacting with human subjects and/or their identifiable data Amanda Bertram, MS

Amanda Bertram, MS

Q4: Which form? eFormA – used for most studies eFormB – used for retrospective studies Protocol takes time but taking time to do it becomes your introduction to your manuscript Specific as possible while being as vague as possible to not pigeon-hole yourself; e.g. online survey vs Qualtrics; collect data in June 2017 Amanda Bertram, MS

Protocol takes time but taking time to do it becomes your introduction to your manuscript Specific as possible while being as vague as possible to not pigeon-hole yourself; e.g. online survey vs Qualtrics; collect data in June 2017 Amanda Bertram, MS

Protocol takes time but taking time to do it becomes your introduction to your manuscript Specific as possible while being as vague as possible to not pigeon-hole yourself; e.g. online survey vs Qualtrics; collect data in June 2017 Amanda Bertram, MS

Q5: What do they mean by study location? Hopkins-only Research conducted only AT Hopkins (any JHH site) Multi-center Each site has a PI Non-Hopkins site Research conducted off-site but researcher is a Hopkins faculty/staff Hopkins-only – surveys being sent electronically fall into this category because they are originating from Hopkins, regardless of where they are being sent. JHCP requires separate IRB application process Multi-center – often requires IRB approval from EACH site Non-Hopkins site – may require IRB from site location Amanda Bertram, MS

Amanda Bertram, MS

Q6: What kind of informed consent? Written consent Oral consent No more than min. risk Consent waiver Obtaining consent is impractical HIPAA waiver Used to review PHI prior to the study (i.e. screening) Oral consent – still explaining the study and getting consent, just orally. Often is a script you will need to follow Consent waiver – e.g. conducting archival research on 1000 participants. This is both too many patients to get consent for and impractical to locate them all Amanda Bertram, MS

Q6: What kind of informed consent? Survey/Questionnaire consent Completion serves as consent No consent = None of the above Anonymous data Survey/Questionnaire consent – sentence indicating completion serves as consent must be included on the survey Amanda Bertram, MS

Amanda Bertram, MS

Q7: How long does all this take? PLAN AHEAD!! Do your IRB/Research Ethics training courses Carefully plan the study Mentors Background Protocol Stats IRB takes 6-8+ weeks IRB meets once a week and you get put into a queue. Can take at least 6-8 weeks to get approval from date of submission if IRB finds no issues Amanda Bertram, MS

Conclusions Find out if IRB submission is needed Plan ahead Work with a team Amanda Bertram, MS