Activities That Require Or Do Not Require IRB Approval

Contents

Introduction

High Level Clarifications

Activities That Require or Do not Require IRB Approval

Information Pertaining to IRB Submissions

Certificates of Confidentiality

New Informed Consent Requirements

IRB Member Recusals

Appealing IRB Decisions

References

Authors

Review and Approval History

Introduction

The SUNY Downstate Medical Center (DMC)Institutional Review Board (IRB) updated Policy IRB-01 on January 19, 2018 due to key regulatory changes. The U.S. Department of Health and Human Services has delayed the implementation of the revised Common Rule (Title 45 CFR part 46) for another 6 months. For more information, please see the OHRP News Release.

Below is a summary of significant changes to IRB-01.

A future revision will be released by July 19, 2018 to ensure compliance with the new Common Rule.

High Level Clarifications

• A draft of the IRB-01 policy was posted in December 5, 2017 with an anticipated start compliance date of January 19, 2018 based on the revisions to the Common Rule that were to go into effect on this date. However, OHRP delayed the implementation of the revised regulations for an additional 6 months. Therefore, we only had one day to make changes and finalize the new policy.
• Some of the administrative content (pages 7-12) was re-arranged to allow ease of future revisions. In specific the information on our statement of principles, overview of regulations and overview of policies will undergo edits that will require future approval by the NYS DOH. Other sections will undergo revisions based on the upcoming changes to the Common Rule.

Activities That Require or Do not Require IRB Approval

• The sections that describe activities that require or do not require IRB approval have been updated to be in compliance with new regulations that will go into effect on July 19, 2018. The new language is congruent with current and future regulations. For more information see pages 12-16 or consult the newly revised “IRB Decision Aid -Application for a Determination Letter to State IRB Approval is NOT Required".
• The policy includes references that we will follow tribal law passed by an official governing body of the American Indian or Alaskan Native tribe (pages 7, 14, 16, 29, and 60)

Information Pertaining to IRB Submissions

• The Emergency Use section has been updated to clarify important steps for the emergency use of an investigational or unlicensed drug, biologic, or device (pages 16-18).
• We have instituted a new IRB application for Review for expanded access to investigational drugs for treatment use.
• We have added information on FDA exemptions (page 21). This is not new information, but was not included in policy in the past.
• We clarified that a study may not undergo expedited review at the time of initial review if the research includes a medical intervention with children, pregnant women, neonates, prisoners, or cognitively impaired adults (page 22).
• We clarified and streamlined our process for External IRB reviews (pages 26-29).
• We added a process for Cooperative Research Review (Single IRB Review). See page 29.
• We added information on in-vitro fertilization (IVF) research. See page 45.
• We clarified that we have guidance for the review of research that recruits participants who are students, residents, fellows or volunteers. See page 47.
• On page 51, we clarified that all research involving drugs and biologics must comply with DMC’s Investigational Drug/Dispensing and Utilization policy (PHA-11)

Certificates of Confidentiality

• We updated our section pertaining to Certificates of Confidentiality (CoC) based on new NIH policy issued on October 1, 2017. See pages 47-48.
• This update applies retroactively to NIH funded research that was approved after December 13, 2016. It will be important to update any informed consent documents to include the new language regarding CoC. See pages 47-48.

New Informed Consent Requirements

• We provide “new recommendations” for elements of informed consent that will eventually become “requirements” that will go into effect under the revised Common Rule on July 19, 2018. These recommendations are congruent with the current Common Rule and the future revision of the Common Rule. Please also see our revised Consent Template. See pages 58-60.
• When developing an informed consent document, be sure to include any requirements of any applicable local jurisdiction where the research takes place or any tribal laws. See page 60.
• Information on obtaining consent from individuals with limited English speaking proficiency has been clarified. This was updated based on the anticipated revisions to the Common Rule, but is congruent with the current regulations. See pages 60-61.
• New criteria for waiving informed consent has been updated in our policy to be consistent with the regulations that will go into effect on under the revised Common Rule on July 19, 2018. This new requirement is consistent with current and proposed regulations. See page 62.

IRB Member Recusals

• We’ve clarified our policy on when an IRB member must be recused from voting on a protocol. If a sponsor requires documentation of a recusal to be stated in an IRB approval letter, please contact the IRB for assistance. See page 71-72, 77 and 82.

Appealing IRB Decisions

• Our appeals process was removed from our policy as it is not a regulatory requirement. Future and more detailed guidance on appealing IRB decisions is forthcoming.

References

• IRB Policy IRB-01 (Version: 01.19.2018)

Authors

Kevin L. Nellis, MS, CIP

Review and Approval History

Original Issue Date: 01.19.2018

Revision Date: N/A

Replaces previous documents: N/A

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