1. The Research Application Process Charles Morgan, Ph.D. Clinical Investigation Department (CID) Naval Medical Center Portsmouth, VA

2. Research Subject Protections Division Staff Paulette Mitchell – Protocol Facilitator Paulette Mitchell – Protocol Facilitator Beth Dayag – Deputy IRB 1 Administrator Beth Dayag – Deputy IRB 1 Administrator Melvina Queen – Deputy IRB 2 Administrator Melvina Queen – Deputy IRB 2 Administrator

3. Research Application Process CID Research Resources CID Research Resources Requirements for research submission Requirements for research submission Research review categories Research review categories

4. CID Research Resources NMCP IRB SOP NMCP IRB SOP Research application forms Research application forms Informed consent form and procedures Informed consent form and procedures

5. CID Research Resources Scientific reviewer checklist Scientific reviewer checklist IRB reviewer checklist IRB reviewer checklist CITI research ethics training CITI research ethics training cv template cv template

6. CID Research Resources Vulnerable Populations Checklists Vulnerable Populations Checklists –Pregnant Women –Children Wavier of Informed Consent Wavier of Informed Consent Waiver of HIPAA Authorization Waiver of HIPAA Authorization

7. Research Requirements Current, dated curriculum vitae (cv) Current, dated curriculum vitae (cv) CITI – Research Ethics Training CITI – Research Ethics Training Electronic application form Electronic application form –Protocol number NMCP.2012.00__ –Expiration date 2012 Signature copy Signature copy –Signature pages only –Scan or fax –No mail or Fed Ex

8. Participation Principal Investigator (PI) Principal Investigator (PI) –Military, Federal employee –Only one PI Associate Investigator (AI) Associate Investigator (AI) Sub-Investigator (SI) Sub-Investigator (SI)

9. Categories of Human Research Based Upon Risk to Subjects Case Studies Case Studies Exempt research Exempt research Expedited review Expedited review Full Board review Full Board review

10. Case Studies – Not Research An interesting case An interesting case Organized observation, collection of data, the beginnings of research. Organized observation, collection of data, the beginnings of research. One or two cases Not considered research One or two cases Not considered research Is not reported to the IRB Is not reported to the IRB Advise obtaining patient consent Advise obtaining patient consent

11. Case Studies - Research Three or more cases – Case Series Three or more cases – Case Series IRB review IRB review Contact CID for application forms Contact CID for application forms –Prior to collecting the data Data collected prior to IRB approval may not be published Data collected prior to IRB approval may not be published

12. Exempt and Expedited Research ExemptExpedited Minimal Risk Research plan Scientific review Chair approval Annual review

13. Exempt and Expedited Research ExemptExpedited Retrospective only Retrospective & Prospective No list Temporary list Waiver of HIPAA NA Waiver of Consent

14. Research considered exempt, 32 CFR 219.101 Research involving the use of educational tests for example, aptitude and achievement tests; or surveys or interviews, are considered Exempt. Exceptions – –a. Information obtained may not be recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects – –b. Research may not be exempt IF: Any disclosure of the 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

15. Research is considered exempt … 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. – –Data collection Sheet – must have no patient identifiers, no combination of data that could be used to identify – –No combination that could be used to identify e.g. 23 yo mother of triplets, gave birth on 10 August, 2008 – –Means no List – temporary or locked up

16. Exempt Research, Examples Retrospective chart reviews Retrospective chart reviews Some surveys with no links to subjects Some surveys with no links to subjects Psychological and physiological effect of mild to moderate sleep loss. Psychological and physiological effect of mild to moderate sleep loss. Psychological studies of learning, conditioning, sensory perception, personality, and group situations. Psychological studies of learning, conditioning, sensory perception, personality, and group situations. Corrective therapeutic exercise. Corrective therapeutic exercise.

17. Expedited Review Minimal risk Specific categories listed in the Federal Register May not be used where identification of the subjects would place them at risk of criminal or civil liability, or be damaging to their financial standing, employability,… – –Includes unintentional identification Temporary list / destroy at end of study Informed consent required – a waiver may be requested

18. Collection of data through noninvasive procedures routinely employed in clinical practice, (not involving general anesthesia or sedation) Weighing or testing sensory acuity. Magnetic resonance imaging. Ultrasound, electrocardiography, Moderate exercise, strength testing, body composition assessment, flexibility testing

19. Collection of data, records, or specimens that have been collected solely for non- research purposes such as medical treatment or diagnosis Retrospective and prospective records review, permitting the use of a list of identifiers. Retrospective and prospective records review, permitting the use of a list of identifiers. List must be kept secure and private. Should be destroyed at end of study List must be kept secure and private. Should be destroyed at end of study

20. Full Board Review Research that is greater than minimal risk Research that is greater than minimal risk Requires informed consent Requires informed consent Literature search Literature search Forms: Forms:Elizabeth.Dayag@med.navy.mil Charles.morgan@med.navy.mil Charles.morgan@med.navy.mil or 757-953-5939 Charles.morgan@med.navy.mil

21. Full Board Review Invasive procedures Invasive procedures Comparison of surgical procedures such as full incision vs endoscopy Comparison of surgical procedures such as full incision vs endoscopy Psychological studies of hypnosis Psychological studies of hypnosis Exercise and fitness testing with extreme loads Exercise and fitness testing with extreme loads Pharmacological studies Pharmacological studies Live virus studies or testing of vaccines Live virus studies or testing of vaccines

22. Application Process PI: Talk with department Research Coordinator, discuss plans, determine if department will support your type of research PI: Talk with department Research Coordinator, discuss plans, determine if department will support your type of research Complete form, Research Coordinator review Complete form, Research Coordinator review Return electronic copy to Portsmouth CID Return electronic copy to Portsmouth CID CID CID –Assigns tracking number –Advises PI on missing items –Sends e copy to scientific reviewers –Collaboration encouraged – needs an agreement

23. Application Process Scientific reviewers return comments, Investigator revises Scientific reviewers return comments, Investigator revises Complete application will be scheduled for IRB review Complete application will be scheduled for IRB review PI can attend IRB meeting via teleconference PI can attend IRB meeting via teleconference

24. Application Process IRB may require or recommend changes IRB may require or recommend changes PI revises, IRB approves PI revises, IRB approves Agreements Verified as Completed Agreements Verified as Completed Final approval by the Commander Final approval by the Commander Upon approval by CO, PI will be notified to begin research Upon approval by CO, PI will be notified to begin research The official consent form will be sent by email The official consent form will be sent by email An official letter of approval will be sent later An official letter of approval will be sent later

25. Questions?