Re-Consenting Subjects Guidance
Version Date: October 10, 2005
Guidance regarding provision of significant new findings and consent form revisions to research subjects
The Health Sciences Institutional Review Boards (HS-IRBs) require disclosure to subjects of significant new findings that develop during the course of a research study, which may relate to the subject's willingness to continue participation in the research study [45 CFR 46.115(a)(7), 45 CFR 46.116(b)(5); 21 CFR 50.25(b)(5), 21 CFR 56.115(a)(7)]. Significant new findings often result in changes to the consent form or protocol after subjects have signed a consent document. The purpose of this document is to provide guidance to researchers regarding the types of information the IRB considers to constitute significant new findings, what changes to the protocol or consent form should and should not be conveyed to subjects, and the means through which the IRB expects significant new findings or changes to be conveyed to subjects.
What constitutes significant new findings requiring report to subjects
Significant new findings generally include, but are not limited to:
- Changes in potential or actual risks or benefits to subjects
- Changes in standard of care, such that participation in research can increase risk to subjects (i.e., subjects would be deprived of the standard of care by continuing to take part in the research study)
- Identification of new risks to subjects currently receiving the study treatment
- Identification of potential late-term effects for subject who completed study treatment
- Discovery that a life threatening or severely debilitating side effect occurs more frequently that previously expected
- Addition or deletion of study procedures or change in number of visits required
- Addition of monitoring procedures
- Addition of new instruments or questionnaires to the study
- Collection of new or different information from subjects
- Substantive alterations to the treatment subjects expect to or currently receive
- The frequency of dosing is increased or decreased
- The route of study drug administration is altered
- Substantive changes in potential costs or payments to subjects
- A drug previously paid for by the study funds must now be covered by insurance or the subject's personal funds
- Payment for or costs of study participation is increased or decreased
The presentation of significant new findings to subjects can be accomplished through various means, including the following.
- A telephone call to subjects to report the significant new findings. The telephone call can be documented in the research file regarding when and who provided the new information to subjects. This method is especially encouraged when verification that subjects have received this information is needed (e.g., due to potential increased risks) and subjects are no longer being seen in person or a significant gap in time would occur between when the new findings are discovered and the next scheduled contact with the subject.
- A letter to subjects is another method that can be used to report significant new findings. This mode of communication may be suitable for information that needs to be communicated to subject when subjects are no longer seen by the researcher in person and which are not life threatening or time sensitive.
- Significant new findings or changes of protocol can be conveyed via a consent form addendum. Use of an addendum, rather than revising the consent document, is particularly encouraged for subjects already enrolled in a research study and when the significant new findings is the only change that would be made to the consent document or only a few changes are proposed. Asking subjects to re-sign multiple consent forms may dilute the importance of the new information and the quality of the consent process. If a revised consent form will be used instead of an addendum, the revisions should be highlighted to draw subjects' attention to the new information.
In general, the HS-IRBs must review the new information to be provided to subjects prior to its dissemination unless the information must be provided to subjects to eliminate an apparent immediate hazard to subjects or others. In the case where the new findings must be reported to subjects before IRB approval can be obtained because of a potential immediate hazard, the researcher must report the dissemination of this information to the applicable IRB within 14 business days.
Significant new findings that the researchers propose to disseminate can be submitted for IRB review using a Change of Protocol. In the case of oral dissemination of new findings, please provide the IRB a copy of the script that will be followed when contacting the subject or describe the information that will be conveyed to subjects. If subjects will be provided with written materials, these documents should be submitted with the Change of Protocol.
When re-consenting subjects should not be pursued
The HS-IRBs are aware that study sponsors often request or require researchers to present revised consent documents to subjects to sign ("re-consent") when they have been revised, regardless of the significance of the new information or change. In many cases asking subjects to sign a revised consent form is inappropriate and may result in needless burden on the subject, presentation of irrelevant information to the subjects and potential dilution of the impact of significant new findings. Consequently, the HS-IRBs generally disallow re-consenting subjects when the revisions to consent documents would not or could not affect the subject's willingness to continue participation in the research study. Examples of situations the IRBs generally would not approve re-consenting subjects include:
- The version number or date on the consent form have been revised and no other changes have been made
- A minor increase in number of subjects to be enrolled in the study
- New risk information about the study drug is discovered which are not late effects and all subjects have completed study treatment
- Addition of new study procedures or additions of study visits that do not pertain to subjects already enrolled in the study (e.g., changes made to screening procedures that only affect new subjects)