1. 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

2. Disclosures
None
Amanda Bertram, MS

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

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

5. 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

6. Amanda Bertram, MS

7. 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

8. 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

9. Exempt
Expedited
Amanda Bertram, MS

10. 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

11. Amanda Bertram, MS

12. 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

13. Amanda Bertram, MS

14. 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

15. 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

16. 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

17. 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

18. Amanda Bertram, MS

19. 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

20. 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

21. Amanda Bertram, MS

22. 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

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