March 4, 2025
For the Record- March 4, 2025: Reasonably Foreseeable Risks, ITHS Recruitment Support Service
In this Issue:
Identifying Reasonably Foreseeable Risks
Update
In our February 7, 2023 newsletter, HSD announced new guidance on identifying reasonably foreseeable risks. Reasonably foreseeable risks are those that participants in the target population would find meaningful to their decision about whether to participate in the research. These generally include risks that: are more likely to occur, are serious, or are being evaluated as part of the research. Regulations require that these risks be presented to participants as part of the informed consent process.
To ensure that these risks are outlined in the consent materials, an additional question has been added to the APPLICATION IRB Protocol to clarify that researchers are ultimately responsible for assessing which risks are reasonable for their study, using HSD’s definition:
![10.1.b. [DETERMINATION] Reasonably foreseeable risks. Reasonably foreseeable risks, which may be a subset of all possible risks, must be described to participants as part of informed consent. It is up to the researcher to determine which of the possible risks listed above are also reasonably foreseeable risks. Reasonably foreseeable risks are those that participants in the target population would find meaningful to their decision about whether to participate in the research. These generally include risks that: are more likely to occur, are serious, or are being evaluated as part of the research. Review the guidance on Identifying and Describing Reasonably Foreseeable Risks in Research for information about which risks should be included as you design your consent process/form. Researchers are ultimately responsible for assessing which risks are reasonable, per HSD’s definition, for their study. An incomplete or inaccurate assessment could result in researcher serious noncompliance. Please confirm your understanding of this responsibility and that all reasonably foreseeable risks have been described in the consent form. ☐ Confirmed](https://www.washington.edu/research/wp-content/uploads/3.4.2025-reasonably-foreseeable-risks.png)
Researchers will now be asked to confirm that they have reviewed HSD’s guidance and included all reasonably foreseeable risks in their study’s consent materials. An incomplete or inaccurate assessment could result in serious noncompliance for the researcher.
ITHS Recruitment Support Service
New
As part of the University of Washington’s Diversity in Clinical Trials Initiative (DCTI), the Institute of Translational Health Sciences (ITHS) has developed a new Recruitment Support Service for researchers with studies subject to the new DCTI policy.
This free service provides consultations to help with recruitment and retention planning, aimed at meeting representation goals. Services include assistance with study design, budget development, input on recruitment materials, and connections to other resources. The consultative team will review both the proposal and the context of implementation to support the determination of characteristics of participants likely to be reached, enrolled, and retained, and help develop strategies to enhance equity and representation. Researchers and their teams are encouraged to contact the ITHS Recruitment Support Service early and preferably in the proposal or grant development phase to discuss and develop recruitment strategies. Researchers who are interested in the consult service should contact ITHS at recruitmentsupport@uw.edu.