UW Research

April 2, 2024

For the Record- April 2, 2024: Diversity in Clinical Trials Bill, PAVE Findings

In this Issue:

WA State Diversity in Clinical Trials Bill

New

In 2023 the WA State legislature passed 2SHB 1745, also known as the Diversity in Clinical Trials bill. This bill aims to improve participation in clinical trials from underrepresented communities (i.e., those more likely to be historically marginalized and less likely to be included in research) so that their data informs and contributes towards better health outcomes in these populations.

One aspect of this bill directs any state entity or hospital (including the UW) to adopt an institutional policy that encourages the identification and recruitment of underrepresented demographic groups into clinical trials. The policy must include:

  • Requirements that investigators collaborate with community-based organizations and use methods recognized by FDA to identify and recruit underrepresented populations
  • Provide information to trial participants in languages other than English
  • Provide translation services or bilingual staff for trial screening
  • Provide culturally specific recruitment materials
  • Provide electronic consent

HSD, along with other collaborative partners (e.g., UW Medicine Office of Healthcare Equity, ITHS, UW School of Medicine) are in the beginning stages of developing policy, guidance and resources needed to comply with the new law. Please note that:

  • Stakeholder input will be sought throughout the process.
  • Researchers will have time to prepare before these new requirements go into effect.
  • Regular monthly updates will be provided via this newsletter and other venues.

 

PAVE 2023 Annual Report Findings and Recommendations

No Serious Non-Compliance Found

HSD’s Post Approval Verification and Education (PAVE) program annual report summarizes outcomes of PAVE evaluations conducted during the prior calendar year. It includes human subjects research studies under UW or External IRB review where a routine or IRB-directed evaluation was conducted. In 2023, the program reviewed 17 studies, which included 16 routine evaluations and 1 directed evaluation. Of the 92 observations made throughout the 17 PAVE visits, there were zero instances of serious non-compliance found. This is great news and demonstrates that UW researchers are conducting safe and compliant research.

There were findings of minor noncompliance. Some of the most common issues observed (and ways to avoid them) include:

  1. Failure to follow the IRB-approved data security requirements. For example, we found studies that had subject identifiers maintained with study data. This is generally not allowed for any study with a Level 3-5 data security level because it may put subjects at increased risk of harm if identifiable information is inadvertently disclosed.
    • Suggestion: In some instances, it may be appropriate to request an IRB exception to this requirement. For example, it may be necessary to temporarily keep subject names with data collection forms to facilitate in-person study visits. HSD allows researchers to request exceptions to individual data security requirements if necessary for the study and if the exceptions do not significantly increase risk to subjects. Exceptions can be requested under Section 9.6.b of the IRB Protocol Form.
  2. Failure to use the current, IRB-approved consent form. Some researchers were not using the most current IRB-approved version of the consent form.
    • Suggestion: Consider using only the IRB stamped approved consent form so it’s easy to see the approval watermark with the IRB approval date so you know you have the current form. Alternatively, use version control in the footer and update this with each consent revision. Also consider putting in place a process to inform all study staff of any consent form changes as well as where to find the most current IRB approved consent form. The current IRB approved version of your consent document can be downloaded directly from Zipline under the Documents tab in the “Final” column.

 

New Consent Resources

New Webpage Available

HSD’s Consent Materials
As of October 1st, 2023, HSD stopped accepting new consent forms using our retired Standard Consent Template. Instead, researchers are expected to design a participant-focused consent process and form using our Designing the Consent Process guidance, optional templates, and example consent forms which are designed to assist researchers with meeting our requirements. You can use one of our templates or build your own consent form using the Designing the Consent Process guidance.

Materials Posted to the New Webpage

HSD has posted a new webpage that provides links to training and tools for building a participant-focused consent.

Interactive tutorial and checklist from the federal Office for Human Research Protections (OHRP)
OHRP developed a 90-minute tutorial to assist researchers with designing a participant focused consent process and form. HSD’s consent materials were based on OHRP guidance and are in line with the tutorial. The accompanying checklist is a useful summary of the most important points in the tutorial.

Consenttools.org
ConsentTools is supported by the Bioethics Research Center at Washington University School of Medicine in St. Louis, MO. They provide resources for optimizing key information, assessing consent comprehension, and obtaining consent using a legally authorized representative. HSD highly recommends reviewing the guidance on optimizing key information and the 5-minute tutorial on incorporating plain language into the consent process and form.

For more information about our expectations for a participant-focused consent, review the eNews from October 3rd.

Contact hsdinfo@uw.edu with any questions.

 

 

Changes to Genomic Data Sharing Consent Requirements Worksheet

Effective Tuesday, April 2, 2024

HSD is retiring the WORKSHEET Consent Requirements and Expectations for Genomic Data Sharing. This was a complex PDF worksheet that described the consent requirements for genomic data that is required to be shared through NIH repositories when research is subject to the NIH Genomic Data Sharing (GDS) policy. Instead, HSD has developed a simplified version of the consent requirements that align with recently updated NIH FAQs. These requirements have been incorporated into one worksheet describing all the GDS certification criteria that must be met for genomic data to be shared under the policy.

Where to find information about GDS consent requirements:

NIH exceptions to GDS certification requirements:

  • When it is anticipated that GDS certification requirements cannot be met: investigators should state this in their data management and sharing plan and indicate what data, if any, can be shared and how. In some instances, the NIH funding institute or center may need to determine whether to grant an exception to the data submission expectation under the GDS policy.
  • When genomic data from specimens created or collected after the effective date of the GDS policy (January 25, 2015), lack consent for research use and data sharing: if there are compelling scientific reasons that necessitate the use of the genomic data, investigators should provide a justification in the funding request for their use. The NIH funding institute or center will review the justification and decide whether to make an exception to the consent requirement.
  • When the research is funded or supported by NHGRI and consent expectations cannot be met: NHGRI will grant exceptions to the consent expectation on a case-by-case basis. Information about how to request an exception can be found in the NHGRI GDS Policy FAQs.

Questions? Contact us at hsdinfo@uw.edu.