Health Research Ethics Committee Records and Reports

Health Research Ethics Committee Records and Reports Dr Oluyemisi Akinwande IHVN

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

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

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

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/termination information What is in a Protocol file (1)

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 What is in a Protocol file (2)

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 To apply to HREC Review …

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)

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)

Minutes (3) • If review necessary more than annually • Serious/adverse event discussions • Deviations/non-compliance issues • Administrative/policy/regulatory issues • Any other discussion

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

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

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…

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

Other Recordkeeping • Policies and procedures • Documentation of training • Keep emails • Document important phone interactions

Records and Reports • Storage • Safety and confidentiality • Paper and electronics • Access to documents • Authorized persons and agencies only • NHREC

Key Points • Document • Document • Document • “If is wasn’t documented, it wasn’t done”

NHREC code section K http://www.nhrec.net/nhrec/ Code of Federal regulations HHS 46.115/FDA 56.115 OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm OHRP guide on engagement in Research OHRP guidance on Engagement of Institutions in Research available on OHRP website List of instructions and forms for IRB registration with OHRP and Federal wide assurance www.hhs.gov/ohrp/assurances/assurances_index.html http://medschool.umaryland.edu/ORAGS/hrpo/toolkit.asp References and Resources

Health Research Ethics Committee Records and Reports