Consent Process and Forms

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
  • Changes to waiver criteria and documentation
  • Public posting of consent documents
  • A “Broad Consent option” for unspecified future use of identifiable data/biospecimens

Key Information in Consent Forms

The new rule states that the informed consent must begin with a "concise and focused presentation of the key information" that would help assist subjects in understanding the reason why they may or may not participate in the research. Key information should be organized and presented in a way that facilitates comprehension. [§46.116(a)] Guidance regarding the expectation of key information is available.

Elements of Informed Consent

Additional items have been added to the elements of informed consent. These new elements will need to be included in consent forms approved after January 19, 2018. The new language includes a basic element of consent that addresses the future use of identifiable private information or specimens.  Three additional elements of consent have been added (when applicable) that relate to commercialization of biospecimens, return of results, and whole genome sequencing. [§46.116(b)(c)]

It is permissible to incorporate these new elements in studies prior to January 21, 2019 since they are not prohibited by the pre-2018 rule.  HRPO will support inclusion of this language to promote transparency in the future use, care, and sharing of identifiable private information and biospecimens.

 

When your project will involve... Include in the Informed Consent:
The collection of identifiable private information or biospecimens

A statement whether :

  • Identifiers may be removed, and
  • if the de-information or biopspecimens may or may not be used for future research or shared with other investigators [46.116 (b)(9)]
Use of biospecimens A statement that the subject’s biospecimens (even if identifiers are removed)
  • may be used for commercial profit and
  • whether the subject will or will not share in the commercial profit [46.116 (c)(7)]
Clinically relevant research results A statement regarding whether the clinically relevant research results, including individual research results, will be disclosed to subjects, and if so under which conditions
[46.116 (c)(8)]
Whole genome sequencing
(i.e., sequencing of human germline or somatic specimen with the intent to generate the genome or exome sequence of the specimen)
A statement indicating that the research will (if known) or might include whole genome sequencing [46.116 (c)(9)]
 
used with permission from University of Michigan

 

Waiver of Informed Consent

An additional criterion has been added that requires investigators to justify the use of identifiable private information or identifiable biospecimens.   In addition to the existing requirements for a waiver the following information must be provided.  This information will be requested as a part of the waiver justification in OSIRIS section 4.7:

  • If the research involves using identifiable private information or biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format [§46.116(f)(2)(iii)]

A waiver of informed consent is no longer necessary for screening, recruitment, or determining eligibility.   This is based on the IRBs determination that there are adequate privacy and confidentiality safeguards in place for the information obtained by investigators.  This aligns with the HIPAA regulations.    In order for the IRB to approve this, the procedures should be listed as a part of the protocol and one of the following conditions must be met:

  • The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  • The investigator will obtain identifiable private information or biospecimens by accessing records or stored identifiable biospecimens. [§46.116(g)]

Posting of Clinical Trial Consent Forms

Federally funded clinical trials must post a copy of the consent form on a “publicly available Federal Web site” (TBD) after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.  Currently there is no instruction from DHHS on the federal website to be used.  HRPO will update the Pitt research community as information becomes available.

Broad Consent

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 identifiable private information or biospecimens for future, yet-to-be-specified research. [§46.116(d)]

The University of Pittsburgh will not be adopting the use of Broad Consent on an institutional level as the tracking requirement may be burdensome. Exemption categories 7 and 8, which are specific to Broad Consent, will not be utilized.  The issues of Broad Consent may be entertained in the future pending further guidance from OHRP.

Portions of this page are adapted with permission from the University of Michigan.