Sumary of Changes to Suny Downstate Irb Policy (Irb-01)

SUMARY OF CHANGES TO SUNY DOWNSTATE IRB POLICY (IRB-01)

A. Compliance:

·  The compliance date to implement changes of the Common Rule (45 CFR 46) is 1/19/2018.

·  HHS has posted a rule to delay the implementation of the Common Rule for one year and allow for 3 provisions that will reduce burdens, but it is not clear which provisions and if this will go into effect before 1/19/2018, as they are awaiting direction from the White House and do not yet know if the changes have to go out for public comment. We will adjust the IRB-01 policy as needed.

·  Actions taken before compliance date are “grandfathered.”

·  The IRB has revised IRB-01 policy by October 2017 as planned to submit to EPIC/MEC to meet compliance deadline and roll out all other related changes.

·  Compliance date for cooperative research review (single IRB for multi-site studies) is 1/20/2020.

·  The IRB will need to determine which set of regulations to follow for each research project (Common Rule, FDA, NYS Article 24A, or non-regulated).

B. Reduce Burdens and Increased Flexibilities:

·  The Final Rule has clarified specific activities that do not require IRB oversight.

·  The IRB may use discretion in applying the Common Rule to non-regulated research; however, the IRB will always apply the principals of the Belmont Report to all research.

·  The SUNY Downstate IRB has joined the Flexibility Coalition and is in the process of benchmarking other institutions which have taken a flexible approach to reduce the burden of IRB of non-regulated research. The IRB may consider the implementation of best practices developed by the “Flexibility Coalition” (e.g., consider other exemption and expedited review categories for non-Federally regulated research, modified criteria for IRB approval, etc.). We need to review best practices and compare to new regulations before we decide if it will be helpful. See: http://oprs.usc.edu/about/initiatives/flex/

·  Reduced reporting burden to OHRP for non-compliance.

·  Expedited studies will no longer require continuing review.

·  The exemption categories have been expanded and broaden the types of research which may qualify for exempt review.

o  The applicability of exemptions to vulnerable populations has shifted:

·  Exemptions can be applied to all research involving pregnant women, fetuses, neonates

·  Exemptions can be applied to some research aimed at involving a broader population that only incidentally includes prisoners

·  Exemptions can be applied to some research involving children, but not all types of research.

o  There are new exemptions that can be applied for use of information of specimens for patients or others which have provided broad consent to use these materials.

o  There are new exemptions that include research involving benign behavioral interventions in conjunction with the collection of information from adults.

·  Grant congruency review is no longer required by the IRB for federally funded studies.

·  The regulations define which activities are NOT required to be reviewed by the IRB.

·  A mechanism for cooperative research review (single IRB review of multi-site studies) has been established. Although this should be a faster process, investigators must learn the policies and procedures of multiple IRBs if they have multiple projects overseen by other IRBs.

·  The Final Rule allows for screening of patients and specimens for research purposes without a waiver of informed consent; however, the HIPAA regulations would still require a HIPAA waiver.

C. Additional Burdens:

·  The Final Rule only applies to federally funded or conducted research.

·  The Final Rule has broadened the definitions related to determining when activities require IRB approval, but this should not significantly impact Downstate, as we already required review of such activities (e.g., use of identifiable specimens for research).

·  New requirements for informed consent.

o  There are many changes to regulations pertaining to waivers of the requirements for informed consent.

o  “Key information” must be presented foremost on consent forms and on consent short forms

o  No consent required for screening procedures that are oral, written, or access records of identifiable information or identifiable biospecimens (IRB approval still required)

o  Broad consent required for exempt 7 (storage and maintenance of identifiable data/specimen) & 8 (secondary research with identifiable data/specimen)

o  One consent form for each federally funded clinical trials must be posted on federally designated website no later than 60 days after the last study visit by any subject

·  Additional burdens for some exempt research:

o  Informed consent is required for some exempt research.

o  Limited IRB review of some exempt research is required to insure information security and privacy requirements

o  Downstate will need to develop a Broad Consent process for some research in order to apply certain exemptions. This will be a complex process and someone needs to track which patients have opted-in and out of the consent process.

·  There will be additional oversight by NYS DOH IRB of some specific research involving interactions with children, cognitively impaired, and prisoners); however, the number of studies that would meet the criteria is anticipated to be only about 3-4 per year.

o  The IRB needs to submit the IRB-01 policy, IRB membership rosters, and statement of principles to the NYS DOH for approval, prior to using the NYS DOH IRB

o  We anticipate there may be delays for final approval by the NYS DOH IRB, as the burden of their oversight will increase on a statewide basis.

o  Previously approved research that meets criteria to send to NYS DOH.

·  If research was exempt or expedited in the past, it must go to the Downstate IRB Full Board before it is sent to the NYS DOH IRB.

·  The NYS DOH IRB must first approve our revised policy, IRB roster, and statement of principles.

·  Enrollment must stop if not approved by the compliance date.

o  The IRB can allow for delegation on a case-by-case basis of research tasks for non-regulated research, like how FDA allows PI to delegate tasks to nurses or other hospital employees; however, the IRB most likely will not permit delegations for obtaining informed consent.

o  All violations which occur in research regulated by Article 24A must be reported to DOH.

·  There will be a shift of reviewing training requirements only at the time of initial review, for studies which no longer require continuing review.

·  The IRB needs to evaluate current studies to determine

o  if any studies need to be submitted to NYS DOH IRB

o  if any changes are needed to amend them to meet the requirements of the Final Common Rule to either reduce burdens or increase protections.

·  The criteria for IRB approval (111 findings) have slight changes. NYC, FDA, and GCP criteria for approval are different, so IRB needs to apply correct criteria for each project as applicable.

o  HHS and OBM will issue criteria for assessing confidentiality of data.

o  We must follow tribal laws passed by the official governing body of an American Indian or Alaska Native tribe

·  The IRB will need to update all application forms, templates, and guidance (e.g., Exempt IRB Application, Informed Consent Waiver, HIPAA Waiver, IRB Decision Aid, Informed Consent Templates, Definitions and Acronyms, IRB Membership, etc.)

·  The IRB needs to establish new IRB Reliance Agreement for when Downstate IRB acts as single IRB for others.

·  At the request of NYC H+H, we are renegotiating the IRB Reliance Agreement for research oversight at Kings County.

·  The IRB has additional requirements for documentation and retention of IRB records.

D. Additional Changes (not related to the Final Common Rule)

·  The FDA now allows for waiver of informed consent for clinical investigations that are no greater than minimal risk.

·  The NIH has broadened the scope for Certificates of Confidentially to apply to most funded research. Under such changes, new language must be added to the informed consent document for this research.

·  In the previous version of IRB-01, the Downstate IRB required full board review research with a Certificate of Confidentially even when it was eligible for expedited review. This additional burden has been removed from the new policy.

·  The policy has been clarified to only require IRB Reliance Agreements for federal funded studies; however, the IRB will process agreements when required by other IRBs or Institutions.

·  A section of the policy was added for research involving in-vitro fertilization.

·  A section of the policy was added to address other potentially vulnerable populations not described in the federal or state regulations.

·  The section of research with drugs and biologicals was updated to be consistent with revised Pharmacy policies.

E. Educational Initiatives

·  The IRB will issue mass e-mail communications for a new “IRB Update” to our research community (about 5,000 members)

·  The IRB will update our IRB reviewer checklists for our members

·  The IRB will establish training programs for investigators and IRB members to ensure regulatory compliance

·  The IRB will update template IRB letters to remind investigators of new responsibilities and to ensure compliance

·  The IRB is in the process of creating new guidance, revising and streamlining the IRB application forms, and creating new educational outreach initiatives for our investigators and IRB.

F. Anticipated Revisions to IRB-01

·  Downstate is not able to implement a process for broad consent by the compliance date of the Final Rule for certain exempt research and therefore cannot approve such research. This policy must be modified in the future.

·  Some legislative and SUNY RF Central Office efforts are underway to possibly request modifications of NYS Article 24A or NYS DOH policies in efforts to harmonize with the revised Common Rule and reduce this burden.

·  Additional changes to the regulations and policies promulgated by the FDA, HHS Office of Civil Rights, NY State, and NIH are anticipated.

·  The IRB-01 policy will be updated as needed in response to the regulatory environment.