1. IHV-Nigeria WAB-TP Health Research Ethics Committee Records and Reports Dr Oluyemisi Akinwande IHVN

2. IHV-Nigeria WAB-TP Records and Reports “If it wasn’t documented, it wasn’t done” HREC administrative office is responsible for keeping the records for the institution Goals –Meet regulatory standards (and beyond) –Meet institutional expectations & standards –Maintain complete files –Files must be organized (easy to access) –Files must be current

3. IHV-Nigeria WAB-TP What does the regulation require? Research File Minutes Records of CR All correspondence b/w HREC and PI Written procedures for HREC Annual protocol reports

4. IHV-Nigeria WAB-TP What does the regulation require? Assurance/Registration HREC members ( HREC Rooster and CV) Statements of significant new findings Other Record keeping ( letters, agreements, certifications etc) Retain records for a minimum of 10 years

5. IHV-Nigeria WAB-TP What is in a Protocol file (1) Full Protocol application materials Reports of action Continuing renewals/approvals Serious/unexpected adverse events Deviations Amendments and approvals Subject complaints Approved consent documents Approved advertisements Investigator Brochures Notes to file Completion/terminatio n information

6. IHV-Nigeria WAB-TP What is in a Protocol file (2) Attendance at meetings Date proposals are submitted and dates approvals given Progress reports Correspondence with PI Copies of all proposals reviewed Data and Safety Monitoring reports All reviews that accompany the proposal

7. IHV-Nigeria WAB-TP To apply to HREC Review … Research proposal All materials to be used for consent process Advertisements e.g. promotional materials, news papers, audio, video and web adverts NHREC certified informed consent training by applicant and co investigators CV (2-3 pages) of PI Letters of support Letter of sponsorship 1 pager of research summary in plain language Other EC reviews and decisions All agreements such as MTA,where indicated

8. IHV-Nigeria WAB-TP Minutes Date, time, location Members present (present, absent, non- voting, guests) Approval of past minutes Actions taken for new and deferred protocols( votes?) Summary of discussions (basis for decisions, controverted issues and resolution)

9. IHV-Nigeria WAB-TP Minutes (2) Actions taken by REC new and deferred –Other special findings (rationale) Granting alterations or waivers of consent (protocol specific) Determinations required by the regulations and protocol specific findings justifying determinations for –Pregnant women, fetuses, neonates, prisoners, children minors etc Actions taken continuing reviews (if applicable include votes, discussions)

10. IHV-Nigeria WAB-TP Minutes (3) If review necessary more than annually Serious/adverse event discussions Deviations/non-compliance issues Administrative/policy/regulatory issues Any other discussion

11. IHV-Nigeria WAB-TP Minutes (4) More is better than less –Should show each protocol adequately addressed all applicable regulations and organizational requirements Develop checklists Don’t get behind: make it a priority Make sure to save a final copy of your minutes

12. IHV-Nigeria WAB-TP Federal wide assurance (FWA) Common rule requires each institution “engaged” in federally supported human subject research file an “assurance” Commitment to protect human subjects Engaged in Research (see OHPR guidance document) –Intervene or interact with subjects –Obtain, release or access individually identifiable private information for research Applies to subcontractors or collaborators –Awardees ultimately responsible

13. IHV-Nigeria WAB-TP IRB registration with OHRP Required for FWA institutions To obtain FWA, designate IRB must be registered with OHRP Required by any IRB or IEC that reviews HHS – supported or -conducted human subjects research or any of federal departments or agencies that have signed up to the common rule and accepts FWA to cover research it is conducting or supporting…

14. IHV-Nigeria WAB-TP Rosters and CVs Assurance includes roster (list of REC members, including their role and affiliation with institution) Maintain and update CV’s at local institution When membership changes, notify OHRP for assurance purposes Alternates –Must bring some expertise to table –Must designate who may serve as an alternate for a particular member

15. IHV-Nigeria WAB-TP Other Recordkeeping Policies and procedures Documentation of training Keep emails Document important phone interactions

16. IHV-Nigeria WAB-TP Records and Reports Storage –Safety and confidentiality –Paper and electronics Access to documents –Authorized persons and agencies only –NHREC

17. IHV-Nigeria WAB-TP Key Points DocumentDocumentDocument “If is wasn’t documented, it wasn’t done”

18. IHV-Nigeria WAB-TP References and Resources 1. NHREC code section K http://www.nhrec.net/nhrec/ 2. Code of Federal regulations HHS 46.115/FDA 56.115 3. OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/enga ge.htm http://www.hhs.gov/ohrp/humansubjects/assurance/enga ge.htm http://www.hhs.gov/ohrp/humansubjects/assurance/enga ge.htm 4. OHRP guide on engagement in Research OHRP guidance on Engagement of Institutions in Research available on OHRP website OHRP guidance on Engagement of Institutions in ResearchOHRP guidance on Engagement of Institutions in Research 5. List of instructions and forms for IRB registration with OHRP and Federal wide assurance www.hhs.gov/ohrp/assurances/assurances_index.html www.hhs.gov/ohrp/assurances/assurances_index.html 6. http://medschool.umaryland.edu/ORAGS/hrpo/toolkit.asp http://medschool.umaryland.edu/ORAGS/hrpo/toolkit.asp