The purpose of Ethical Committee (EC) review as part of the clinical trial process is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, Institutional Review Boards (IRBs) use a group process to review research protocols and related materials (e.g., informed consent documents).
Since the development of electronic patient reported outcomes (ePROs) in the 1990s, it occasionally occurred that the ePRO system providers included printouts of “screenshots” of the ePRO forms for IRB and EC review as a supplement to the protocol. Since the final version of screenshots required prior design, implementation, and user site testing (UST), the provision to ECs was usually a late step in review of a study.
As the inclusion of screenshots became more common, sponsors and some ECs began to expect them, and requests came earlier in the review process. In such cases, the process increased the time required for implementation prior to final approval. As ePRO providers questioned the need for early review, sponsors pointed to GCP (ICH E6 R2) wording that ECs “should obtain…written information to be provided to subjects” (Paragraph 3.1.2), a category of study documents that were given to subjects during recruitment that could influence their decision to consent.
ERT’s point of view
In two publications on this topic1,2, the authors, including IRB representatives, pointed out that examples of “written information to be provided to subjects” only applied to the information used to explain to the potential clinical trial participant the aim of the trial, the financial implications, and the advantages and disadvantages of participation in the trial. These publications point to the burden and cost of providing screenshots and of review by EC members, and call into question the value of including such material.
What should be submitted to Ethical Committees?
ERT believes that patient consent language and descriptions of processes and burdens upon participants are an important part of what the EC needs to review. The list of questionnaires is always included in the clinical trial protocol, and a printed version should also be part of this protocol. If this is not the case, the EC may reasonably request a paper version to assess any sensitive content or suitability of the effort it would take for completion.
Why does ERT believe that screenshots are not required for EC submission?
GCP guidelines do not specifically require the submission of screenshots of PRO instruments, nor do they require operational screens, such as error messages, device usage instructions, or password creation. We do not see evidence that screenshots of the patient consent language and questionnaire items provide substantially superior evaluation of the rights and welfare of clinical trial participants in comparison to the protocol versions of that content.
If a paper copy of the screenshots is already available from prior implementations, whether in English and/or in the local language, the delay in providing may be less, but the cost of filing and review by the EC personnel remains. Delaying the submission when such documents are not yet available is not justified and even unethical in a way, as it could postpone the development of a new drug that could solve unmet medical needs.
An ERT presentation on this topic is available upon request.
1 Raymond S et al. Optimizing Electronic Clinical Outcome Assessment Materials Required for IRB/EC Review. Medical Research Law & Policy Report. 2016; 15 MRLR 159.
2 Gertel A et al. Demystifying Submission of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary? Applied Clinical Trials. Aug 14, 2020.
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