Changes to Human Subjects Research Regulations – Effective January 21, 2019

Changes to the Federal Policy for the Protection of Human Subjects (Common Rule–45 CFR 46) are scheduled to go into effect this coming Monday, January 21, 2019. These changes, issued by the Department of Health and Human Services (DHHS), are intended to reduce administrative burden, increase protections to human subjects, and offer additional flexibility. The changes affect research and clinical investigations involving human subjects and subject to the authority of BU’s Institutional Review Board (IRB).

Which studies are affected?

As of now, the changes are scheduled to go into effect this Monday, January 21, 2019.  This means that any NEW study approved on January 21, 2019 or after will be subject to the new requirements. This will apply to:

1. New studies that are currently under review but are not approved until January 21, 2019 or after,
2. Any new studies submitted to the IRB prior to January 21, 2019 that have not been reviewed and approved until January 21, 2019 or after, and
3. All new studies submitted on or after January 21, 2019.

If DHHS changes the effective date of the changes, we will notify investigators who will be affected by this change.

What’s changing?

Below is a summary (not an exhaustive list) of the major changes:

Which requirements apply to my study?

Your IRB Analyst will work with you to determine which requirements will apply to your study. If you currently have a study under review and have received modifications from the Analyst, you must submit your responses to the Analyst by January 14, 2019 in order for the study review to be completed under the old requirements. If you do not respond by January 14, 2019 or your response is not complete, your study will be subject to the new requirements. In this case, the IRB Analyst will work with you to ensure the new requirements are met.

Where are the updated policies and forms?

All applicable policies, forms, and templates have been revised with the new requirements (see below) and will be available on the CRC IRB website after January 21, 2019. Please see below for a list of the revised forms and policies.  If you are submitting to the IRB on or after January 21, 2019, you must use the revised forms. All other forms and policies have remained the same.

Revised Policies

• Amendment/Modifications to Previously Approved Research
• Clinical Trials Registration and Results Reporting
• Convened Meeting
• Continuing Review
• Research Involving Cognitively Impaired Adults
• Exception & Deviation Policy
• Documentation of Informed Consent
• IRB Review of Exempt Human Subjects Research
• IRB Review of Human Subjects Research using Expedited Procedures
• Research Involving Human Subjects
• IRB Recordkeeping
• Recruitment and Advertising
• Waiver or Alteration of Informed Consent

Revised Forms/Applications

• IRB-CRC Amendment Request
• IRB-CRC Consent Form Template and Script
• IRB-CRC Exempt New Application
• IRB-CRC Expedited/Full Board New Application

If you have any questions, please contact the Charles River Campus (CRC) IRB at 617-358-6115 or irb@bu.edu.