Revisions to the Common Rule:
Frequently Asked Questions
Do these regulatory changes apply to my study?
Response: The Common Rule regulations (§45 CFR 46) are the regulatory basis for IRB review applied to all federally-funded studies, or to studies submitted by organizations or institutions under an FWA who have elected to apply the Common Rule to their non-federally funded research. Studies that under FDA regulation will typically only have the Common Rule applied if they have funding (whole or in part) from a federal agency/source. If you are unsure what regulations applied to a previously approved study, you can find them listed on the E&I IRB Approval Certification. Or, for assistance.
How will these changes to the Common Rule affect my on-going, previously approved studies?
Response: It varies.
Do I need to make any immediate changes?
Response: Maybe, but only if you are wanting to request a modification to transition your study to the revised Common Rule as soon as possible, and the expiration date for your existing study is near. In this case, you will need to make sure that your study adheres to all of the revised Common Rule regulations, particularly those requiring changes to consent form(s). This will allow you to submit your request for modification to transition your study at the same time that you submit your study materials for continuing review.
Otherwise, no changes are needed until you elect to transition your study.
Do I have to submit my existing, on-going study (approved prior to January 21, 2019) for its next scheduled Continuing Review?
Response: Yes. All studies approved by full board or expedited process must undergo their next continuing review
Do I need to make any changes to my existing study (approved prior to January 21, 2019) before my next continuing reivew?
Response: Maybe, but only if you are ready. All studies approved prior to the implementation date must undergo the their next scheduled continuing reivew before a transition to the revised common rule can occur. If you choose to transition your study, a completed Request for Modification to Transition form must be submitted, along with all applicable modified documents. This request can be submitted with the continuing review submission (at least 30 days prior to expiration) or it can be submitted anytime after the continuing review, without incurring any additonal cost.
What exactly does "Key Information" mean and is there a template?
Response: Under the new requirements, informed consent must begin with a concise and focused presentaton of the key information that is most likely to assist a prospective subject in understanding the reasons he or she might or might not want to participate, and it must be organized and presented in a way that does not merely provide lists of isolated facts, and there must be an opportunity to discuss that information.
Although a quick online search will produce templated sections of key information to drop into all consent forms, most will likely include the same list of elements shown below.
This information isn’t wrong, which is why it is required to be disclosed in the consent form to begin with, but it also may not include what is likely to be of key importance to the specific subject population being targeted for your study.
So how do you know what is important to your population? We suggest that, when possible, you start by having a clearly defined identity of who your ‘ideal’ subject is, and the populations from which you are trying to recruiting them. Once you know your subject, ask some general questions about them, such as those below (suggested by SACHRP).
At the requesst of OHRP, SACHRP provided commentary on the New "Key Information" Informed Consent Requirements. We found it helpful. It is available on the list of additional resources below.
What is Broad Consent and how does it work?
Response: Broad consent is an alternative to the use of traditional, study-specific informed consent or to IRB approved waivers of informed consent when working with the storage, maintenance and secondary research uses of identifiable private information and identifiable biospecimens. Broad consent remains effective for the lifetime of each person who consents, permitting ongoing future use of their identifiable data and/or identifiable biospecimens for generally defined research purposes, unless revoked at a later date. Should an individual be asked and refuse broad consent, the IRB may not approve a waiver of informed consent for any future storage, maintenance or research uses of the individual's identifiable data and/or identifiable biospecimens. Broad consent presents an option to give individuals more input and autonomy regarding the way their identifiable personal information and identifiable biospecimens are used.
Certain challenges exist however, in the management of broad consent. The tracking requirements of all individuals who give, refuse, and revoke broad consent, and the resulting limitations to future uses of consent waivers, creates a requirement for a program of management with a significant tracking system beyond the capabilities of most organizations or institutions. This either limits the use of broad consent to a very select few, who can meet the management demands, or it limits the use of broad consent to a more select targeted audience, where tracking becomes easier.
Broad consent is a requirement for research activities determined to be exempt under categories 7 and 8 of the revised Common Rule, determined by the IRB through Limited Review. The required elements of broad consent are specific and align only in part with the requirements of informed consent.
The introduction of broad consent as an alternative, does not eliminate other options to researchers, who may find de-identification, or the use of consent waivers more appropriate to their study design.
Do I have to re-consent existing subjects with a consent form that includes all of the new required elements?
Response: No. The changes made in adherence to the revised Common Rule do not require participants to be re-consented. If however, you make additional changes beyond those required by the revised rule, the IRB may require re-consent, based on the additional changes made.
Do I have to transition my study before I implement changes to my consent document consistent with those in the revised Common Rule?
Response: No. If your study was approved prior to January 21, 2019, you may elect not to transition to the new Common Rule and stil choose to implement changes from the 2018 revisions, as long as those changes do not conflict with the prior requirements. As an example, you may decide that even though you do not wish to transition your study, you would like to add the Key Information paragraph to the top of your consent form. This would be acceptable, but don't forget that you must recieve IRB approval of the changes prior to implementing them.
Where can I get more help?
You should always feel free to contact your IRB Administrator at E&I for additional assistance.
Here is a list of additional resources you might also find helpful:
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