informed_consent

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UMKC Implementation: Consent Changes

Effective January 21, 2019, the requirements for informed consent will change, with the addition of: 
  • "Key information" to be presented at the beginning of the consent form
  • New Consent Elements (the full set of required and additional elements)
  • Changes to waiver criteria and documentation (plus other process changes)
  • A "broad consent" option for unspecified future use of identifiable data/bisopecimens 

The intent of these changes is to facilitate the subjects' understanding of the proposed research and also ensure that they understand how their data and biospecimens may be used.

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Key Information (examples of a concise summary)

The preamble to the Final Rule (revised) lists five (5) factors as suggested "key information" that would likely assist a potential subject in understanding the nature of the project and in determining participation.

informedconsent_keyinfo

How a study team applies the "key information" requirement, and to what level of detail, will depend on the complexity of the research project.  Many social/behavioral research projects already employ a brief informed consent document, so including a "key information" section may be redundant.  The Final Rule preamble includes some considerations regarding the application of this requirement, but further federal guidance is expected at a later date.

If you have questions about how to apply the new "key information" requirement for a particular project, contact the UMKC IRB Office for advice.

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New Consent Elements (for the entire list of required and additional elements according to regulation)

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

For new Consent Form Templates that are compliant with the 2018 Common Rule, go here.


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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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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 & 8, which rely on Broad Consent, will not be available as exempt determination submission categories.  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
  • Exempt Category 4
  • De-identification to remove the research activity from Common Rule purview and not require IRB review or consent