Informed Consent – What Changed with the New Common Rule?

Effective January 19, 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  (See the informed consent checklist)
  • Changes to waiver criteria (See the waiver application form)
  • A “broad consent” option that will not be implemented at GS for unspecified future use of identifiable data/bisopecimens.  Related exemption categories 7 & 8 will also not be implemented at GS.

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.  The dropdown menu below will provide more information about each category.

Key Information

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.

  1.  A statement that the project is research and participation is voluntary
  2. a summary of the research including purpose, Duration and List of procedures
  3. Reasonable, foreseeable risks or discomforts
  4. Reasonable, expected benefits
  5. Alternative procedures or course of treatment (if applicable)

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.

Most projects conducted at Georgia Southern utilize a short consent form (less than 4 pages) so a separate key information section will not be required.

New Consent Elements
Project element Include a statement in the informed consent:
General Requirement Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.
Identifiable Private Information A statement indicating:

  • if identifiers may be removed, and
  • if de-identified information or biospecimens may or may not be used or shared for future research
Use of bio-specimens A statement indicating:

  • if bio-specimens may be used for commercial profit, and
  • if the subject will share in that profit or not.
Clinically relevant results
  • 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)

indicating that the research will or might include whole genome sequencing

 

Waiver or alteration of consent (including waiver of documentation by signature)

Waiver or alteration of the requirements for obtaining informed consent from adult subjects can occur if all provisions are met and the IRB agrees that no additional harm will be incurred by the subjects through the waiver:

    1. Research in general: an IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(e), provided that the IRB finds and documents that all of the following five conditions are met:
      1. the research involves no more than minimal risk to the subjects;
      2. the research could not practicably be carried out without the waiver or alteration;
      3. If identifiable private information/biospecimens are collected, the research could not be practicably carried out without using the information in an identifiable format;
      4. the waiver or alteration will not adversely affect the rights and welfare of the subjects; and
      5. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

A waiver can not be approved by an IRB where broad consent has been requested.  Conditions of the broad consent must be applied.

Broad Consent

Georgia Southern University will not mandate or implement the Broad consent option in the standard based upon the burdensome tracking requirements necessary to maintain this option.  Data access utilizing current regulation options will be maintained.

Broad Consent under the new rules means – seeking prospective consent to conduct unspecified research in the future utilizing identified data.  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.

Additional Resources:

USC Key Changes to the Common Rule.  (16 min – concise explanation)  (USC policy on broad consent is the same as GS)

 

Last updated: 1/22/2019

Office of Research Integrity • PO Box 8005, Statesboro, GA 30460 • General Inquiries: (912) 478-2359 • irb@georgiasouthern.edu