October 12, 2021
For the Record – October 12, 2021: A New Tutorial; Updated Guidance
- IRB101: Tutorial and New Requirement
- Consent Revision Project
- International Research
- FDA Issues Individual Investigator Notice of Noncompliance
- Finding Guidance on the HSD Website
- New Cannabis Question
IRB 101 Tutorial and New Requirement
Required for Students and Residents Starting in December 2021
HSD is now offering a new online tutorial called IRB 101: Get Started Fast. It is currently recommended for anyone new to working with the UW IRB, such as students of all levels and new study coordinators. In approximately 1 hour, this resource provides an overview of what an IRB is and what it does, how to determine if an IRB application is required, and a quick overview with practical tips for submitting IRB applications online. It is most useful for those who already have a research project in mind.
Beginning in December 2021, students and residents who are listed as the principal investigator on an IRB application are required to take the IRB 101 tutorial and provide their training certificate with their application materials. See the HSD website for more information, including detailed information on providing training certificates to the IRB and some FAQs.
Please send any questions or comments about the new tutorial to email@example.com.
Consent Revision Project
What is the Consent Revision Project?
Obtaining informed and voluntary participant consent is one of the most fundamental and important activities for conducting ethical and compliant human subjects research. In response to campus requests, evolving national best practices, a rich recent literature about consent practices from ethicists and investigators, and a desire to focus on consent from the participant perspective, HSD has been working on a major overhaul of its consent-related policies, requirements, SOPs, guidance, and templates. The project is divided in multiple phases occurring over 2-3 years. We are grateful to several prominent local bioethicists and investigators who have been willing to assist HSD with suggestions and feedback, as well as pilot feasibility assessments of a new approach to consent forms.
What is Phase 1 of the Consent Revision Project?
The Phase 1 changes were implemented on October 8, 2021. They include:
- Revision of consent-related policies. Specifically, most UW-specific requirements are now recommended best practices rather than requirements. This allows more flexibility for the development and approval of consent processes and materials that are adapted to fit specific research populations and circumstances.
|Old Policy||New Policy|
|Required that subjects receive a signed and dated copy of the consent form||Required that subjects receive a copy of the consent form.
Best practice to provide subjects with a signed and dated copy.
|Required that subjects sign the IRB approval stamped version of the consent form.||Best practice for subjects to sign the IRB approval stamped version of the consent form.
Required that the form they sign matches the content and formatting of the approval stamped version.
|Best practice to include version date or version number in the header or footer of the consent form.||Required to include version date or version number in the header or footer of the consent form.|
|Required that the person obtaining documented consent sign and date the consent form.||Required that the person obtaining documented consent legibly type or print their name and date on the consent form.|
|IRB determines when translations are required.||Translations required for all consent materials (and some recruitment materials) that will be provided to subjects in written or electronic form.|
|Required that the IRB prospectively approve the use of LAR consent if it was reasonably likely that it would be used.||IRB can limit or not allow use of LAR consent, but prospective approval is not required for its use.|
- Creation of a single, easily searchable-and-navigable, web-based Consent Guidance resulting from revision and consolidation of several Word-based documents about aspects of consent. This means that most previous consent-related documents (e.g., SOP Consent; SOP Translation and Interpretation; SOP Legally Authorized Representative) are now retired.
- Creation of TipSheets on consent, which summarize specific aspects of the new guidance for researchers (a tip of the hat to the Fred Hutch IRB for their TipSheets, which served as our role model).
- Consolidation of practical information about Electronic Consent Signatures, into a single webpage.
- More emphasis on the Key Information requirement and on obtaining meaningful consent from the perspective of the subject population. These are captured as five Consent Considerations.
What is Phase 2 of the Consent Revision Project?
The existing HSD consent templates will be completely revised to eliminate unnecessary requirements and specific wording and to focus on the perspective of the research participants. New templates for specific types of research will be developed. The first of these will likely be implemented in early spring 2022.
This means that there will be a temporary mis-match between the best practices described in the new Consent Guidance and the existing consent templates. Researchers may continue to use the existing templates but are also welcome to trying new approaches to consent forms as described in the Consent Guidance.
How should researchers change what they do now?
The only requirements are related to UW policies. While it is not required to use the Consent Considerations in the new guidance, researchers are encouraged to take advantage of new flexibility to develop consent processes and materials that are more focused on the perspective of the subjects.
New guidance about research conducted in international locations has been posted to the HSD guidance webpage. It uses a Question-And-Answer format to address the issues most frequently raised with HSD and the IRB. Example topics:
- What information researchers should provide the UW IRB about their international research
- The UW IRB’s role in reviewing international research
- Additional requirements “in country”
- Translated consent materials
The guidance also includes a new requirement for studies involving greater than minimal risk: translated consent forms and study materials must be accompanied by an attestation of translation. This is accomplished by using a new HSD form called TEMPLATE Translation Attestation which is filled out by the researcher upon request from the IRB. By providing this attestation, the translator is confirming to the IRB that the translation represents a true, accurate, and complete translation of the English document(s). Note that this attestation requirement is not the same as “certification”, which is a professional translation credential. HSD is continuing its policy of requiring certified translations only in those infrequent circumstances for which the IRB believes it is appropriate.
FDA Issues Individual Investigator Notice of Noncompliance with ClinicalTrials.gov Results Reporting
On August 31, 2021, the FDA issued its first ever Notice of Noncompliance letter to an individual investigator for failure to comply with the requirements for submission of clinical trial results to ClinicalTrials.gov. This is the third Notice of Noncompliance that FDA has issued this year. Note that recipients of these notices have 30 days to submit trial results or face civil monetary penalties up to $12,316 per day.
For UW research, HSD identifies whether a study is an ‘applicable clinical trial’ that requires registration and results reporting on ClinicalTrials.gov. This is communicated to the researcher via Zipline. Researchers who are identified as the Responsible Party for an applicable clinical trial should ensure they understand the reporting requirements and timelines for submission. Information can be found on the HSD website.
UW researchers who receive an FDA notice or pre-notice of non-compliance should contact HSD at firstname.lastname@example.org for guidance.
Finding Guidance on the HSD Website
HSD is gradually moving, consolidating, and re-formatting all of its Word-based guidance documents to webpages in a single Guidance section of the HSD website. This includes information previously included under Special Topics. In addition, new content will be added over time. All guidance documents will continue to also be available through the HSD Policies, Procedures, and Guidance search button in the lower right part of the HSD homepage.
Advantages of web-based guidance:
- A single location will make it easier and faster to find specific topics.
- HTML webpage formats provide more organizational options (e.g., hide/show features; hyperlinks), which improves the readability and usefulness of information.
- Webpages provide more accessible information for visually-impaired users.
New Cannabis Question
A new question about cannabis and related compounds has been added to both versions of the IRB Application form (“IRB Protocol”) and to the REQUEST External IRB Review form. The purpose of the question is to ensure that HSD and the IRB are able to identify research that involves cannabis, hemp, CBD, and related compounds so that any regulatory requirements are met. The question appears in the forms available on the HSD website. The forms available for downloading directly from Zipline will be revised during the next Zipline update (early December).