Changes to Research/ Additional Document Submissions
Whenever a change to the protocol or consent form is proposed, the change must be reviewed and approved by WCG IRB before being implemented, unless a serious safety concern requires immediate implementation by the investigator, or if the change is a non-substantive formatting change to an already IRB-approved consent form as described in the section below titled “Non-Substantive Consent Form Format Updates.”
Submit a change in research review request via the ClinSphere® eReview Manager or IRBNet.
Non-Substantive Consent Form Format Updates
While the content of consent forms is key, sometimes minor formatting characteristics of the document can impair the ability of participants to understand the content, or study staff to convey the content, so the following types of limited formatting changes can be made when necessary or appropriate to enhance participant understanding:
- Add page breaks before headings to ensure that the heading is connected to the related paragraph.
- Add page breaks to prevent signature lines and signature instructions from being spread out over two or more pages.
- Remove extra carriage returns within a document to shorten it from, for example, 5 ¼ pages to 5 pages.
WCG IRB does not consider these changes substantive or to require IRB review and approval, but because changes like this can change the number of pages in the document, we encourage you to verify any minor changes like the ones above are acceptable under your local policies and to the sponsor/CRO and/or SMO involved in the research.
Font changes can be impactful, so we do not allow changes meant to emphasize text, such as size, color, bolding, italicization, underlining, or other changes with similar intent. However, if study staff would like all text in a paragraph to be uniformly the same font, such as all Arial or all Times New Roman, this change can be made without IRB approval,
We encourage submitters to use Word tools like styles, “keep lines together,” or “keep with next” to automate formatting and eliminate the need for the manual fixes outlined above.
Changes to Research to Eliminate Apparent Immediate Hazards to Research Participants
WCG IRB has received questions from research sponsors about the appropriate process for making changes to clinical studies in response to emergencies such as the COVID-19 epidemic, hurricanes, earthquakes, and other natural disasters. These changes may include things like:
- Decreasing the number of protocol-mandated in-person study visits to healthcare facilities.
- Replacing protocol-mandated visits to healthcare facilities with home visits or telemedicine, allowing blood draws at remote or commercial laboratories
- Shipping investigational products directly to research participants.
We want to provide information on the requirement for IRB review of changes in research made in response to this situation.
The FDA regulations require that:
Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human participants. 21 CFR 56.108(a)(4).
If a sponsor or investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported to the IRB within five (5) days, as per WCG policy. Eliminating immediate hazards may include actions to reduce potential exposure to a pandemic, or to continue to provide medically necessary study care (including study drug) to participants unable to physically visit a healthcare facility. WCG encourages sponsors and investigators to take such steps as necessary to eliminate apparent, immediate, or additional risks to participants.
The notification to the IRB may be a full protocol amendment, but it does not have to be. The notification of the change in research (CIR) plans may also be a memo, letter, or other document that explains the changes being made, and provides enough information for the IRB to assess the relative risks resulting from the changes. The amendment or CIR document will proceed through IRB review as per the usual process.
If you have questions, please contact your WCG IRB representative, or Client Care, and they will connect you with a member of our regulatory, medical, or compliance teams as needed.
Changes to Research: How to Submit
A Protocol Change
Requests for review of protocol changes must include the exact text of the amendment, administrative change, or other revision to the protocol, a summary of changes, the rationale for the change, and a copy of the WCG IRB-approved consent form with the proposed changes clearly marked (if applicable).
When submitting a change to the protocol with corresponding consent form changes, use the Change in Research submission pathway and indicate you have both a consent form change and a protocol revision. Incomplete and inaccurate information may result in delayed reviews.
Please note: if you are a sponsor or CRO representative who is submitting a change in research and new PI(s) are currently pending initial approval, you should provide instructions in your submission regarding how to proceed with the PI’s currently pending initial review:
- Provide instructions to IRB staff as to whether IRB staff should “hold the review of the new PI(s) until the change in research is complete so that the PI(s) pending initial approval can receive the new change in research as part of their initial review approval package,” or indicate if the “review of the new PI(s) should proceed without waiting for the review of the new change in research to be completed.”
- If you instruct us to continue processing the PI(s) that are pending review and NOT hold them, WCG IRB will need to receive a separate change in research request to issue approval of the change to any PI’s who need it and have not yet received it.
A Consent Form Modification
Requests for consent form modifications should be submitted via a change in research request via erm or IRBNet. You’ll be prompted to submit a copy of the current WCG IRB-approved consent form with proposed changes clearly marked (or a document specifying the requested changes). Proposed changes to the consent form should be “redlined” into an electronic copy of the current WCG IRB approved consent form. In order to facilitate the submission of consent form changes, WCG IRB now routinely provides sponsors and CROs with a clean copy of each WCG IRB-approved consent (without site specific information in it). Changes sent to WCG IRB on the sponsor’s template consent form will not be accepted.
WCG IRB does not recommend marking changes with a highlighter alone, as the highlighting can be lost or can obscure information when the document is scanned into WCG IRB’s electronic workflow system.
In general, a statement justifying changes is very helpful and can reduce the need for WCG IRB to contact sites for explanations. Whenever revisions are requested to previously Board-approved language, the submission must include a rationale, and changes to study procedures that are described in the consent form must be supported in a revised protocol.
If the changes are to be submitted for a multi-site study, the same changes might have already been approved by WCG IRB for another site. If you agree to accept the changes already approved, your review will take place more quickly. You can contact WCG IRB Client Care to determine if pre-approved language exists for your change in research.
Investigators who provide instructions for use of a consent form other than the one already approved by WCG IRB, or who request significant changes to that version, will experience delays in the review process while their unique consent forms are prepared for Board review. Additional delays may occur if the Board has questions about the consent form or if the investigator does not accept Board-required changes to the submitted consent form.
Because sponsor version dates or numbers listed in headers or footers of consent forms are not an IRB requirement, but are voluntary information listed on consent forms, WCG IRB does not routinely update the information listed unless the submitted consent form indicates that information should be updated. WCG IRB uses IRB approval date stamps to track the IRB-approved versions and content. We have observed that the consent form version identifiers used by sponsors, CROs, and institutions vary across the industry. As a general rule, the IRB will not proactively make any changes to sponsor/CRO or institution versioning, but instead we follow the instructions provided by the submitter.
WCG IRB does not routinely list site addresses on consent forms, other than the investigator’s main address, as the inclusion of site locations on a consent form causes unnecessary revisions to these documents, is not required by regulation, and provides no additional safety protection for participants. This results in shorter, simpler consent forms that require fewer administrative updates. If a site address must be included on an investigator’s consent form, rationale should be provided to the Board for the inclusion of the additional locations.
The Board will provide instructions on the Certificate of Action indicating what participants should be re-consented with the updated consent form. If you have a preference for which participants should be re-consented with the updated consent form, you may provide that information via the submission form when the consent form changes are submitted, and the Board will accommodate the request if possible, but may require you to re-consent more participants than you indicated in your preference. The Certificate of Action indicates the minimum expectation for re-consent, but you are welcome to re-consent more participants than required (there is no need to ask the Board for permission to do so). If you would like the Board to require re-consent of fewer participants, you may PROMPTLY contact WCG IRB and ask for a reconsideration (citing your rationale); however, we advise you not to delay complying with the Board’s instructions. More information about application of the Board’s re-consent instructions is provided in the section below.
Applying the Board’s Requirements for Re-consenting Subjects
After the Board reviews new information in the consent form(s) and determines the appropriate participants that should be provided with the new information, the Board’s requirements are communicated on the Certificate of Action (COA). Three commonly used re-consent requirements are outlined below and referenced in the tables below.
Study Visit = “WCG IRB reviewed new information in the above Consent Form(s). Please inform all participants for which there is an in-person or remote interaction and new participants (if enrolling) of the changes. Document the communication in the research records (e.g., Note to File or participants signing the consent form). This is the Board’s minimum expectation. Sites can choose to inform or re-consent additional participants.”
All = “Please have current participants, including those who are in follow-up and no longer completing study visits, and all future participants sign the Consent Form(s) specified in this approval.”
Future = “Please have all future participants sign the Consent Form(s) specified in this approval. This is the Board’s minimum expectation. Sites can choose to inform or re-consent additional participants.”
The two tables below provide the Board’s expectations regarding who to obtain consent from and which consenting method(s) can be used based on the issued phrase.
Status of Participants:
| Board’s Consent Determination from COA: (see notes above for details of each determination) | Screening (New) | Receiving Treatment | Safety FUP* after EOT** (clinic visit or remote) | LTFU*** or survival FUP* |
| Study Visit | Yes | Yes | Yes | No |
| All | Yes | Yes | Yes | Yes |
| Future | Yes | No | No | No |
*FUP = Follow-up
**EOT = End-of-Treatment
***LTFU = Long term follow-up
Consenting Method:
| Board’s Consent Determination from COA: | Clinic Visit | E-Consent | Telephone/ Telehealth | |
| Study Visit | Yes | Yes | Yes* | Yes |
| All | Yes | Yes | Yes* | No |
*If the Board has approved use of e-consent for some or all subjects in the research.
How to Request a Reconsideration:
Items disapproved by the Board can be reconsidered upon written request. The request must include a rationale for the reconsideration. Additional information may allow the Board to favorably respond to the request. There is no additional fee for the reconsideration of disapproved items. Reconsiderations of Board-directed modifications do not incur additional fees if the requests concern re-review of the same language or item originally reviewed by the Board. If new or alternate language is submitted, the Change to Research fee applies.