Chapter 44

Terms of Use Documents

As noted above under “Materials Required for Initial Review,” materials to be provided to participants require IRB review. When research studies involve the use of digital technology, there may be Terms of Use or similar, otherwise named articles to which participants are required to agree if they are to be in the research. Often, these Terms of Use include exculpatory language that would not meet regulatory criteria for IRB approval. Sometimes the sponsor of the research has control of these Terms of Use and can modify them at the IRB’s request, but often, third parties own these documents. In 2020, The Secretary’s Advisory Committee on Human Research Protections (SACHRP) published recommendations on review of these titled Attachment B – Clarifying Requirements in Digital Health Technologies Research (Attachment B-Clarifying Req. Digital Health Technologies Research | HHS.gov), and WCG uses this recommendation document as the basis for our policy on reviewing Terms of Use for digital technologies used in research studies. This policy addresses the four scenarios in which the technology and associated Terms of Use are encountered and the resulting requirements.

  1. The technology is acquired by the participant outside of the research context and is being used in the research for the same purpose for which it was acquired:
    1. The risks involved in the use of the technology are not research risks.
    2. The Terms of Use does not need to be reviewed by the IRB.
    3. Exculpatory language in the Terms of Use document is not part of the research and does not need to be edited.
  2. The technology is acquired by the participant outside of the research context and is being used in the research for a significantly different purpose than for which it was acquired:
    1. The risks involved in the use of the technology may alter the risks of the research.
    2. The Terms of Use document does not need to be reviewed by the IRB.
    3. The existence of the Terms of Use document should be disclosed to the participants and any risks of the use of the technology in the research should be considered as research risks and be disclosed in the consent form/process.
  3. The technology is required as part of the research, but the technology is not designed or controlled by the sponsor of the research.
    1. The risks involved in the use of the technology are research risks and should be disclosed in the consent form/process.
    2. The Terms of Use document does need to be reviewed by the IRB.
    3. The IRB should ensure that any differences in confidentiality protections or other provisions between the Terms of Use document and the rest of the research are disclosed to participants.
  4. The technology is required as part of the research, and the technology is designed or controlled by the sponsor of the research.
    1. The risks involved in the use of the technology are research risks and should be disclosed in the consent form/process.
    2. The Terms of Use document does need to be reviewed by the IRB.
    3. The Terms of Use document should be edited as needed to meet regulatory requirements (non-exculpatory).
    4. In the rare case where it is not possible or practicable for the document to be altered, the IRB may still decide that the study may proceed, and the IRB should ensure that any differences in confidentiality protections or other provisions between the Terms of Use document and the rest of the research are disclosed to participants.