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Human Subjects Protections Update

After five years of effort, federal agencies have published the final rules for the Federal Policy for the Protection of Human Subjects, more commonly known as the Common Rule. The new rule was published on January 19, 2017, with most changes going into effect one year later on January 19, 2018.

The federal Office for Human Research Protections received more than 2,100 public comments on the plan since it was announced in 2011. Washington University's institutional response was submitted on January 5, 2016, and can be found at http://research.wustl.edu/Resources/CommonRule/Documents/Common_Rule_Comment_Letter.pdf

Some of the major changes are highlighted below, and the full text of the final rule can be viewed on the Federal Register website at federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects​

Summary of the Major Changes in the Final Rule

Proposals not being adopted

  • The final rule does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.
  • To the extent some of the NPRM proposals relied on standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance.
  • The final rule does not expand the policy to cover clinical trials that are not federally funded.
  • The final rule does not adopt the proposed new concept of “excluded” activities. Generally, activities proposed to be excluded are now either described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The proposed revisions to the exemption categories have been modified to better align with the long-standing ordering in the final rule. The final rule does not include the proposed requirement that exemption determinations need to be made in specified ways.
  • The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Aspects of proposals that relied on those safeguards have been modified or are not being adopted.
  • The final rule does not adopt the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.

Significant changes to the Common Rule

  • Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an institution may choose to implement instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study. However, use of this may require tracking those that decline at an institutional level so that their data and/or specimens are not used for research going forward.
  • Establishes new and revised exempt categories of research. Some categories of exempt research would now be required to undergo limited IRB review to ensure that there are adequate privacy and confidentiality safeguards for identifiable private information and identifiable biospecimens.
  • Creates a requirement for U.S.-based institutions engaged in cooperative research that is federally funded or conducted to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective 3 years after publication of the final rule.
  • Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.

Timeline

October 7 - 30
Comments accepted from Washington University community via email to ovcrinfo@wustl.edu

October 30
Comments from Faculty Participant Group due

October 30 - November 9
Initial draft prepared

November 9
Summary of comments due to Vice Chancellor for Research

November 30
Final draft response prepared for institutional review and approval

December 4
Comments to draft institutional response​ accepted from Washington University community via email: ovcrinfo@wustl.edu

January 5
Institutional response​ submitted

January 6, 2017
Members of the Washington University community are encouraged to submit individual responses to the Office for Human Research Protections until January 6, 2016

January 19, 2017
Final rule published

Previous Communications Regarding Changes to the Common Rule

The following was published by the OVCR in January 2016 to communicate proposed changes to the Common Rule, and is provided here for reference purposes only.

Federal Agencies have proposed changes in the​ Federal Policy for the Protection of Human Subjects more commonly known as the Common Rule. These changes have been published in the Federal Register and comments are requested. The proposed changes are extensive and impact our biomedical and behavioral researchers, IRB, and institutional offices. The changes in the Proposed Rule include changes to the definition of human subjects, research involving bio-specimens, secondary research use of identifiable data, modifications to the determination of exempt research and establishment of a new category of excluded studies, requirement for the use of a single IRB for multicenter studies, changes to informed consent, and development of new privacy and security standards. The link to the Proposed Rule is www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf​.

The Research News announcement on the Common Rule changes from the Vice Chancellor for Research can be found at research.wustl.edu/researchnews/Pages/Changing-Human-Subject-Regulations,-please-send-us-your-comments.aspx​

Washington University's institutional response can be found at
https://research.wustl.edu/Resources/CommonRule/Documents/Common_Rule_Comment_Letter.pdf

Resources and Links

Several organizations are providing information and analysis concerning proposed changes to the Federal Policy for the Protection of Human Subjects. These resources and links are listed below for your easy access.

​We recommend:

Office of Human Research Protections Resources
The Office of Human Research Protections website has a number of resources available at http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html

​Ropes & Gray Webinar
Ropes & Gray has several resources concerning the background of NPRM and the proposed changes on its website.

Excerpt of Common Rule NPRM Questions
Downloadable document of questions for public comment.

Upcoming webinars:

AAMC Webinars
The AAMC is providing a number of webinars regarding the Proposed Common Rule changes. The links below will enable you to register for any webinar that interests you. In addition, AAMC has given us permission to post these slides on our website so this information will also be available to you if you cannot participate in the webinars.

Other resources you may find useful:

Huron​ Webinar: NPRM Discussion
By: Madeleine A. Williams, Thomas Bechert
Download a copy of the webinar slides and a digital summary of the most significant NPRM changes at http://www.huronconsultinggroup.com/Insights/Webinar/Education/Webinar-NPRM-Discussion

​​PRIM&R Resources
PRIM&R has several tools and references on its website that may be accessed at http://www.primr.org/publicpolicy/nprmresources

Takin’ Care of Business Conference Slides
Downloadable slides from a panel discussion on proposed informed consent changes from the Regional Human Subject Protection: Takin' Care of Business Conference.

Verrill Dana Academic and Clinical Research Group (ACRG) NPRM Resources
ACRG Redline of Common Rule NPRM (9-4-2015)
Download Decision Charts that visually present four NPRM issues as well as the redline version of the Common Rule (above) at http://www.verrilldana.com/decision-charts-to-help-you-navigate-the-common-rule-nprms-proposed-landscape-of-covered-research-exclusions-and-exemptions

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