Changes to the Informed Consent
Summary of Changes
- [New] "Key information" to be presented at the beginning of the consent form
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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)
- 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.
- 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.
- 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).
