Research & Economic Development

Office of the Vice Chancellor

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New Consent Elements

When your project will involve... Include in the informed consent...
The collection of identifiable private information or identifiable biospecimens

A statement indicating whether:

  • identifiers may be removed, and
  • de-identified information or biospecimens may or may not be used or shared for future research
Use of biospecimens

A statement indicating whether:

  • biospecimens may be used for commercial profit, and
  • the subject will share in that profit
Clinically relevant results

A statement indicating whether the clinical results, including individual research results, will be returned to the subject, and if so, under what conditions

Whole genome sequencing

(i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen

A statement indicating that the research will or might include whole genome sequencing

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Consent Process Changes

  • A waiver of informed consent for the secondary use of identifiable private information/biospecimens (not covered by Broad Consent) must justify why the use of identifiers is necessary to carry out the research.
  • Use of identifiable information/biospecimens to identify potential subjects (i.e., screening for recruitment purposes) is allowed without informed consent under certain circumstances.  A waiver of consent will no longer be needed for these screening activities.

Note:  HIPAA requirements still apply - including asking for a HIPAA waiver.

  • For federally-sponsored clinical trials, a copy of the consent form must be posted to a "publicly available, federal website" (TBD) post-recruitment and no later than 60 days after the last study visit by any subject.

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Broad Consent

Broad Consent Defined

"Seeking prospective consent to unspecified research."  

~ Revised Common Rule:  Federal Register, Vol. 82 No. 12 (January 19, 2017)

Under the current regulations, secondary research use of identifiable data/biospecimens is permissible through study-specific consent, by obtaining an IRB waiver of consent, or by removal of identifiers. 

In the revised Common Rule, "Broad Consent" is an (optional) alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research.  To utilize "Broad Consent," the study team and/or the unit/biorepository responsible for the storage of the identifiable data/biospecimens are required to:

  • identify the types of research that may be conducted with the data/biospecimens, 
  • record and track who has agreed to or refused consent, and
  • to track the terms of consent to determine whether proposed future secondary research use falls within the scope of the identified types of research

For full details about "Broad Consent" including the requirements (in addition to tracking), limitations, and considerations for use, see SACHRP's Recommendations for Broad Consent Guidance.(link is external)

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UMKC BUSINESS PROCESS

Warning iconAt this time, the UMKC HRPP and IRB will not mandate nor implement the institutional use of Broad Consent, as the tracking requirements may be burdensome.  Exemption categories 7 and 8, which rely on Broad Consent, will not be available as application types.  UMKC will continue to support study teams seeking subject permission for the collection and storage of identifiable private information/biospecimens for future secondary use research through the following processes:

  • Study-specific consent and comprehensive IRB review 
  • IRB waiver of consent (as eligible) and comprehensive IRB review
  • Exemption #4
  • De-identification to remove the research activity from Common Rule purview and not require IRB review or consent

Note:  For studies designed to collect identifiable data and/or biospecimens solely for the purpose of maintaining a repository, the study team may find it useful to employ a specialty informed consent template (e.g., biorepository template).

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UMKC Transition Process

INFORMED CONSENT TEMPLATES

The UMKC IRB have posted updated informed consent templates to their respective websites.  Study teams should begin using the updated informed consent templates as soon as they are available on the websites.

EXISTING STUDIES

Due to the differing nature of the research and the volume of approved studies, the UMKC IRB is taking separate approaches towards transitioning existing studies to comply with the revised Common Rule, including any updates to informed consent documentation.  Contact the UMKC IRB Office for further information.

NEW STUDIES

New studies submitted for IRB review after January 21, 2019 must utilize an updated informed consent template to ensure compliance with the revised Common Rule.

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IRB applications submitted shortly before January 21, 2019 may not be reviewed in time to qualify under the current human subjects protection regulations.  Applications undergoing the review process at the time of transition may be returned to the study team to update the informed consent elements.

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References and Resources

Questions?

To ask a question, express concerns, or provide suggestions about human subjects research protections at UMKC, please send a message to umkcirb@umkc.edu.