The revised Common Rule, which goes into effect January 21, 2019, includes changes to the requirements for informed consent. These changes only apply to studies reviewed and approved on or after January 21, 2019 under the revised rule. The goal of the changes is to facilitate the understanding of a prospective subject or legally authorized representative in regards to the reasons why one might or might not want to participate in the research. The primary changes include:
- New process requirements for the content, organization, and presentation of information
- A new requirement that informed consent begin with a concise and focused presentation of key information
- New requirements for the basic and additional elements of consent
- Changes to the criteria for waiver/alteration of consent and to the requirements and waiver criteria for written documentation
- A new provision allowing the IRB to approve a research proposal without individuals’ informed consent for screening, recruiting, or determining eligibility for inclusion in the study
- A new requirement for clinical trials to post a copy of the approved consent form to a federal website.
- A broad consent option is added for unspecified future use of identifiable data and bisopecimens
- A new UO informed consent form template and template guidance incorporating the revised Common Rule changes are now available.
Changes to General Requirements for Informed Consent
The informed consent must be organized and presented in a way that facilitates comprehension. This includes the addition of a Key Information Summary (see below for more details). The consent process must provide subjects with information that a “reasonable person” would want to have to make an informed decision. Informed consent as a whole must present information in sufficient detail relating to the research and must be organized and presented in a way that does not merely provide lists of isolated facts but rather facilitates the prospective participant's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
As an alternative to informed consent requirements for research involving identifiable private information and biospecimens, an option was added to use broad consent in specific circumstances.
Key Information Summary
The informed consent process must begin with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the consent process must be organized and presented in a way that facilitates comprehension. To accomplish this, a section is added to the beginning of the informed consent form that is used to facilitate this process. We are terming this the “Key Information Summary”.
How each Principal Investigator applies the key information requirement, and to what level of detail, will depend on the complexity of the research. The preamble to the revised Common Rule suggests the following five elements be included as the key information summary:
- A statement that the project is research and participation is voluntary
- A summary of the research, including:
- List of procedures
- Reasonable, foreseeable risks or discomforts
- Reasonable, expected benefits
- Alternative procedures or course of treatment, if any
New Basic and Additional Elements of Informed Consent
In addition to key information discussed above, the revised Common Rule added some basic and additional elements (when applicable) of informed consent which are outlined below:
|When your Research Involves...||Include in the Informed Consent...|
|The collection of identifiable private information or identifiable biospecimens||
One of the following statements:
|Use of biospecimens||
A statement indicating whether:
|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|
When research involving biospecimens…
|A statement indicating that the research will or might include 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)|
Changes to Waivers or Alterations of Informed Consent
The revised Common Rule adds and revises the previous criteria for waiver. These include major changes to the content, format and organization of the general waivers and alterations within the regulations and additional criteria for research accessing or using private information or identifiable biospecimens.
Key changes include:
- New criteria allowing for a waiver or iteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials.
- Changes to the criteria for a general waiver or alteration of informed consent.
- A new provision allowing the IRB to approve a research proposal without individuals’ informed consent for screening, recruiting, or determining eligibility for inclusion in the study, if certain criteria are met.
Click here for a preview of our new guidance on waiver/alteration of informed consent.
For federally-sponsored clinical trials, a requirement has been added that a copy of the consent form must be posted to a "publicly available, federal website" (such as clinicaltrials.gov) post-recruitment and no later than 60 days after the last study visit by any subject. We are still awaiting confirmation from the federal government as to which federal website will be established as a repository for clinical trial consent forms.
Per the revised Common Rule, a clinical trial means “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”
In the revised Common Rule, "broad consent" is an alternative consent process only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research. The use of broad consent requires that the investigator maintain a sophisticated tracking system. For this reason, and because the regulations permit the secondary research use of identifiable data/biospecimens through study-specific consent, IRB waiver of consent, or removal of identifiers, the UO IRB does not plan to implement the broad consent option at this time. Please contact Research Compliance Services if you have any questions.
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.