UW Research

October 4, 2022

For the Record- October 4, 2022: New Guidance on Reasonably Foreseeable Risks, HSD/IRB Turnaround Times, PAVE Annual Report, NIH DMS Policy

In this Issue:

Coming Soon: New Guidance on Reasonably Foreseeable Risks

An Opportunity for Comment

Human subjects regulations require that informed consent include the ‘reasonably foreseeable risks’ of the research. However, there is no existing guidance for researchers on what that means or how to pragmatically determine what to include in a consent form. This is particularly challenging for those doing interventional drug or device trials. The result is that we often end up with long, unwieldy consent forms that include every possible risk and occasionally situations where key risk information has been left out of consent forms.

HSD is working to develop concrete guidance and we want to hear from researchers. We will be holding 2 online forums in October to present our draft guidance and collect feedback:

  • Friday October 7th 10-11AM
  • Tuesday October 11th 10-11AM

If you are interested in participating, please email hsdinfo@uw.edu with your preferred date and we will send you the zoom link!

Complete the Zipline Support Survey

Help HSD Improve Zipline Resources

HSD needs your help to improve Zipline resources! Please complete a short survey to provide feedback on what current Zipline resources you use most and what future Zipline resources you’d be most likely to use. The survey contains 6 questions and should take less than 5 minutes to complete. After completing the survey, you have the option to enter a drawing to receive a coffee gift card as a thank you for your participation.

Turnaround Times for HSD and IRB Review

Plan Accordingly

HSD and IRB review turnaround times have remained steady for 2 years. The turnaround times in the table below represent the average median turnaround times over the last 8 quarters (2020 Q3 – 2022 Q2). Turnaround times are measured in calendar days from the time of submission to the time the final approval or determination letter is sent.

Median Turnaround Times (TAT) for New Applications

Review Type Average Median Turnaround
Determination: a formal determination that a project does not require IRB review because:

·    It is not considered to be research

·    It does not involve human subjects

·    It is not considered to be UW research

 6 days
Exemption: a determination that the human subjects research fits into one or more exempt categories that do not require IRB review or require only limited IRB review. 6 days
Expedited: IRB review conducted by a designated voting member rather than by the convened committee. It is used for minimal risk research that fits into one or more of the permitted expedited review categories. 16 days
Full Board: IRB review by the convened committee at a scheduled meeting. This is required for research that is not eligible for exemption or expedited review. 68 days

Tips for a smooth and timely review

  • Plan ahead. Review times can vary depending upon the type of review, complexity of the study, HSD staffing shortages, submission volumes etc. Be sure to allow enough time for review.
  • Check for completeness. Carefully read all instructions. Be sure that you have provided thorough answers to relevant questions and uploaded necessary documents before submitting your application.
  • Satisfy requirements for student research (if applicable). If you are a student or resident listed as PI on an IRB application, you must:
  • Click the “submit” button. The application can only be submitted by the PI or assigned PI Proxy. If you are preparing the application for the PI, email the PI a link to the study by copying and pasting the URL. The PI can then:
    • Log in and submit the application by clicking on Submit and then on OK, OR
    • Assign the PI Proxy so the PI Proxy can submit.
  • Contact HSD. Reach out to your review team or email hsdinfo@uw.edu if:
    • You are not sure if you need to submit an application for review
    • You are not sure if UW is the correct IRB to review your research
    • You have other IRB-related questions

PAVE 2021 Annual Report Findings and Recommendations

Avoid the Most Common Issues

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 2021, the program reviewed 16 studies, which included 14 routine evaluations and 2 directed evaluations. PAVE also conducted targeted consent audits for 19 studies to assess researcher compliance with HSD’s e-consent and e-signature requirements. The good news is that the vast majority of findings were minor noncompliance. UW researchers are generally conducting their studies in a safe and compliant manner.

Some of the most common issues (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 in REDCap. Some researchers using the REDCap e-consent platform were not using the most current IRB-approved version of the consent form. Often this was the result of uploading a draft version of the consent form but forgetting to upload the final, IRB-approved version.
    • Suggestion: Consider uploading a PDF copy of the IRB stamped approved consent form (versus the unstamped Word copy) so it’s easy to see the approval watermark and know you have the current form. Alternatively, use version control 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 find the most current IRB approved consent form.

New NIH Data Management and Sharing (DMS) Policy

Effective January 25, 2023

Policy. NIH has issued a new policy to promote the management and sharing of scientific data generated from NIH-funded or conducted research. The policy establishes the requirement for submission of a data management and sharing plan (DMS plan) with the funding application for research that results in the generation of scientific data. The DMS policy applies to all funding mechanisms submitted on or after the effective date. The new policy does not introduce new requirements for the protection of human research participants but does have implications for privacy protections and informed consent.

DMS Plan. NIH program staff determine if the DMS plan is acceptable. The plan must address the 6 key elements described below. For research that is subject to both the DMS Policy and the NIH Genomic Data Sharing (GDS) Policy, a single plan that addresses both policies is required at the time of application. See Writing a Data Management and Sharing Plan for more information about NIH expectations.

  1. Data Type: scientific data to be managed and shared
  2. Related Tools, Software, and/or Code: any tools needed to access or manipulate shared data
  3. Standards: any standards that will be applied to the scientific data
  4. Data Preservation, Access and Associated Timelines: repository to be used, persistent unique identifier, and when/how long data will be available. NIH requires data to be shared no later than the time of publication or end of the award, whichever comes first.
  5. Access, Distribution or Reuse Considerations: description of factors affecting subsequent access, distribution, or re-use of data.
  6. Oversight of data management and sharing: how compliance with DMS plan will be monitored and managed. Noncompliance with the NIH approved DMS plan may result in an enforcement action.

Considerations for sharing human subjects data. Researchers should:

  • Communicate plans for future sharing and use of scientific data in consent forms.
  • Assess the privacy and confidentiality protections needed for sharing data from research participants. Unless a participant consents to sharing identifiable data, it should generally be shared only in a de-identified format.
  • Consider justifiable limitations to sharing data. These include (but are not limited to) uses of the data as described in the consent form and when sharing would compromise subject privacy or safety.

For more information, see NIH’s supplement to the DMS policy Protecting Privacy When Sharing Human Research Participant Data and the webpage Sharing Data from Human Participants.

Costs. NIH recognizes that making data accessible and reusable may incur costs. Researchers may request funds toward data management and sharing as explained in Budgeting for Data Management and Sharing.

Additional Resources.

Selecting a Data Repository