Changes to the Informed Consent

Changes to the Informed Consent

Summary of Changes

  •  [New] "Key information" to be presented at the beginning of the consent form
  • If you are collecting private information or identifiable biospecimens for future research you must include one of the following statements:
    • Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject.
    • The subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
  • Additional Elements of Informed Consent 46.116(c) - Three New Requirements (when appropriate)
  1. Biospecimens: a statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  2.  Clinically relevant results: a statement about whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
  3.  Whole genome sequencing:  a statement about whether the research project might include whole genome sequencing.

UMass IRB/HRPO has updated the consent templates available on our webpages to reflect these changes.

Studies approved BEFORE January 21, 2019

  • Impact on Researchers: NONE
  • The new consent requirements will NOT be applicable.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • The new consent requirements WILL BE applicable to all studies.
  • UMass IRB/HRPO will provide guidance regarding new requirements for consent documents during the IRB protocol review process.
  • UMass IRB/HRPO has updated the consent templates available on our webpage to reflect these changes (https://www.umass.edu/research/compliance/human-subjects-irb/forms).

Last modified: 

January 14, 2019
  • Compliance, Human Subjects/IRB, Research Ethics
  • Research Compliance