The IRB is announcing plans to require select research studies submitted prior to 1/21/19 to consent participants on the revised Common Rule elements. Background and details about these requirements follow.
On January 21, 2019, the revised Common Rule went into effect. A key change with the revised Common Rule included new informed consent requirements for both minimal risk research undergoing expedited review, and greater than minimal risk research undergoing convened review. These included:
- Consent Summary—Informed consent must begin with a concise, organized, and focused presentation of the key information that is most likely to assist a prospective subject in understanding why one might or might not want to participate.
- Future Use—A statement about whether the research involves any plans for the future use of the private information and/or specimens collected.
- Returning Clinically Relevant Research Results—A statement regarding whether clinically relevant research results, will be disclosed to subjects, and if so, under what conditions.
- Collection of Identifiable Biospecimens—When the study involves the collection of identifiable [coded and directly identified] biospecimens, the following elements of consent are required:
- A statement that the biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this profit
- A statement regarding whether the research will or might include whole genome sequencing.
Previously, studies that were approved by the IRB prior to 1/21/2019 were not required to revise their consent forms to include these new required elements.
In November 2021, Penn Medicine and Penn Audit, Compliance and Privacy distributed a new guidance on the sharing of patient and research participant data and biospecimens with third parties. The guidance can be viewed here: https://oacp.upenn.edu/penn-medicine-guidance-on-sharing-data-and-biolog…. Those working with Penn patients, even if they are not part of Penn Medicine (e.g., School of Nursing researchers) should be familiar with this guidance. Any questions about the guidance itself should be directed to the contacts within the document.
A major element of this guidance is ensuring that participants are informed of data and specimen sharing outside of the institution for primary and secondary (i.e., future) uses.
As an accompaniment to this guidance, the IRB worked with Penn Medicine leadership and Penn Audit, Compliance and Privacy to update the template Future Use consent language with the intention to facilitate planned and unplanned future data and specimen sharing.
This language is: “The information [and samples] may be shared with other researchers within Penn, or other research institutions, as well as pharmaceutical, device, or biotechnology companies.” This language is contained in the current Informed Consent template.
At this time, the IRB is announcing that the following research studies submitted prior to 1/21/19 are required to consent participants on the revised Common Rule new consent elements, utilizing the Penn Informed Consent Template language. Consent templates from 4/2021-the present include the appropriate language.
- Expedited (minimal risk) and Convened (greater than minimal risk) studies that are open to subject enrollment (i.e., study team is still enrolling);
- Expedited (minimal risk) and Convened (greater than minimal risk) studies where subjects are actively participating in study procedures (i.e., study team is in active contact with these subjects), regardless of enrollment status (i.e., open or closed to new enrollment).
The IRB expects that, for the above studies, existing enrolled subjects will be re-consented on elements of future use, and as they apply, returning research results, commercial profit, and whole genome sequencing. The rationale for requiring re-consent is their importance in being identified as new consent elements as part of the revised Common Rule, as well as their impact on patients’ rights to be informed of these activities. If study teams do not plan to re-consent existing enrolled participants, rationale must be provided to the IRB and will be considered on a case by case basis.
Execution may look different depending on the type of study, its enrollment, and its active participation. The IRB is open to being flexible. The IRB also understands that some consent forms may contain existing sponsor language that may cover some of these elements. The IRB recommends that study teams perform an assessment of their current consent language.
Studies with active enrollment should ideally revise their main consent forms. However, if a study is closed to new enrollment with active participants, and study teams do not want to revise their main consent forms, the IRB will accept submission of a consent addendum with the revised Common Rule elements. If this option is selected, study teams should include the consent addendum in subsequent continuing review submissions.
If you previously revised your consent form to include these new elements but did not re-consent previously enrolled subjects, reconsent of those subjects is now required. If subjects were previously re-consented with these new elements present, no further action is required.
The IRB strongly recommends that the changes be submitted prior to the end of October 2022 and, if applicable, be paired with another planned modification. The IRB is aware of staffing constraints across the institution. The IRB will not conditionally reapprove continuing review submissions through the next year for failing to meet these requirements. However, the IRB will begin conditionally reapproving continuing review submissions starting May 2023 that do not meet the above requirements. This gives study teams approximately 1 year to complete this change, and reminder notes will be provided. In summary, October 31, 2022 is the soft deadline. April 30, 2023 is the hard deadline.
Studies not meeting one of the two criteria above are recommended to seriously consider storage of study data and any potential for planned or unplanned future uses and disclosures outside of Penn. Likewise, studies relying on external central IRBs should also consider this.
If there may be any possible sharing of data or specimens outside of Penn for future uses, the IRB strongly recommends revising consent forms to include future use language utilizing the current Penn Informed Consent form template. Depending on enrollment and active subject participation, the following may be considered to achieve this: a revised informed consent form, a consent addendum, or an opt out letter.
This is recommended to facilitate data and specimen sharing in alignment with the Penn Medicine Guidance on Sharing Data and Biological Samples with Third Parties. Likewise, it will also facilitate the increased requests from publications to share data and specimens to the database of Genotypes and Phenotypes (dbGaP), even if the study is not NIH funded.
It is critical that the following language be included as part of the future use language to facilitate data and specimen sharing: The information [and samples] may be shared with other researchers within Penn, or other research institutions, as well as pharmaceutical, device, or biotechnology companies.
If the above language is not present in a consent form, the language may be found to be inadequate, and sharing may not be permitted institutionally, even if the IRB has approved the consent form.
The IRB advises that storage of data and specimens for future uses may be optional, but the IRB is not dictating one way or the other. However, the IRB advises teams to seriously consider the resources needed for making future uses optional, as consent and dissent must be appropriately tracked.