October 2, 2020
DF/HCC Research Community,
Please review this message in its entirety for important updates and guidance from OHRS related to:
- COVID-related modifications to trial procedures or consent process
- Process for “bundling” amendments
- Translation of previously approved documents
- Updates to Outside Interest and Attestation Form
COVID-related Modifications to Trial Procedures or Consent Process:
OHRS advises Investigators and study teams to consider whether contingency measures implemented to manage study conduct during the disruptions necessitated byCOVID-19 may require an amendment under FDA regulations. Depending on the nature of the changes, a protocol amendment may be required. The FDA suggests that investigators and sponsors should assess whether the study may be conducted under the existing protocol or whether more long-term amendments are needed. For example, alternative methods for safety assessments implemented to avoid immediate harm to participants and staff, should, if continuing, be reviewed by the IRB to determine whether in-person visits are necessary to fully assure the safety of trial participants. If a remote consent process is planned for the foreseeable future, the process for obtaining consent should become part of a revised protocol and approved by the IRB. Depending on the nature of the amendment, it may not require scientific or feasibility reviews, and in some cases may be an expedited review. Please note that changes implemented in response to COVID-19 per DFCI policies may continue until the amendment is approved. Also, operational procedures in clinics that may be altered during the pandemic are not considered part of the protocol and do not require IRB review.
We also anticipate that unavoidable protocol deviations related to COVID may continue to occur and should continue to be reported in the usual manner to the IRB as COVID-related deviations.
Process for ‘Bundling’ Amendments Implemented
In order to reduce delays related to submission of an amendment during the time that a new protocol application is being reviewed, especially if that amendment is required prior to opening of the study for accrual, we have implemented a procedure to attempt to ‘bundle’ the first amendment with the initial review of the protocol by the IRB. Because this is a nuanced assessment of where in the process a current submission is, a senior staff member of OHRS will be assigned to evaluate whether conducting two concurrent reviews is possible. This determination will depend on the nature of the amendment (whether it requires scientific or feasibility reviews) and at what stage of review the current submission has reached. Please contact the OHRS office through the general mailbox and Senior Staff will contact you promptly regarding next steps [firstname.lastname@example.org]. Investigators may also follow these procedures when two amendments arrive in quick succession from the sponsor.
Translation of Previously Approved Documents
Submissions of translations of previously approved documents such as consent forms, participant diaries, and other related subject communication, which involve a certified translation with no other changes, should be submitted in iRIS. These should be submitted as an amendment while selecting the “editorial” changes option in the proposed changes section in the amendment form. This will ensure that there is no unnecessary delay caused by routing to extraneous review groups. RIO will be updating the instructional text in the proposed changes section of the AM to clarify that this option should be chosen when translating previously approved documents.
Updates to Outside Interest and Attestation Form
The Office of Research Integrity has made an update to the Outside Interest and Attestation Form. The form has been modified to define who must make a Conflict of Interest (COI) disclosure to ensure consistency with the all relevant guidance. All investigators, sub-investigators, and study personnel who are involved in the design, conduct, or reporting of the research, or who will make a direct and significant contribution to the research (e.g., recruiting subjects, administering the informed consent document, determining subject eligibility, generating study data, assessing primary endpoints, evaluating efficacy data, etc.) must complete this form at the time of initial new protocol submission or when being added to a protocol later, even if they have no financial interests to report.
Questions regarding the Outside Interest and Attestation Form may be directed to the Office of Research Integrity: email@example.com
All other questions may be directed to OHRS@dfci.harvard.edu