Standard Informed Consent Template

• All appearances of the term “subject” have been replaced with “participant.”
• Most orange boxes indicating ICH-GCP-specific instructions have been revised to pertain to all research as applicable.
• Office of Technology Transfer’s name change to Innovation Partnerships has been incorporated.
• IRBMED has developed new approach to addressing participation in sub-studies, depending on whether the substudy/ies involve factors, such as procedures or risks, that differ significantly from those in the main study. 
• To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section, which is numbered section 12. 
• The signature section (formerly section 12) is shifted down to a new section 13.

• All but one orange box formerly containing information specific to research subject to ICH-GCP standards have been revised to pertain to all research as applicable; this takes either of two forms:
  • The orange box has been changed to blue and references to ICH-GCP have been removed
  • The text of a former orange ICH-GCP box has been incorporated into body text
  The one box that remains orange and remains confined to ICH-GCP studies is the directive above the witness signature box, instructing researchers to characterize witnesses as impartial.
• In section 1.1 (key information), sample descriptions of clinical trial phases have been rewritten.
• Also in section 1.1, new help text guides researchers in choosing which study risks represent key information and which needn’t be included in this section.
• In section 4.1, guidance on blinded studies has been narrowed to apply only to certain scenarios.
• Sub-studies: Help text in section 4.1 (study procedures) now directs researchers to describe their sub-study(-ies) in one of several parts of the consent document:
  • Sub-studies that involve factors, such as procedures or risks, that are similar to those in the main study, or that involve only storage and/or use of samples and information gathered in the main study, appear in section 4.1 or the new section 12. These instances are expected to be the most common.
  • Sub-studies that involve factors, such as procedures or risks, that differ significantly from those in the main study should now appear in an appendix added to very end of the template. These instances are expected to be relatively uncommon.
  Recommended language for use in sub-study descriptions has also been condensed and revised.
• In section 5.1 (risks), help text pertaining to efforts to mitigate study risk has been rewritten.
• Also in 5.1, risk language regarding COVID-19 vaccination has been inserted.
• Recommended language regarding study benefit (section 5.2) has been revised.
• In section 8.1, which addresses costs of study participation, help text regarding costs of treatment for study-related injury has been revised by the Calendar Analysis and Review Office (CRAO) to reflect changes in university policy. These policy changes affect investigator-initiated and federally sponsored research only.
• The blue box guiding researchers on explaining mitigation of confidentiality risk in section 9.1 has been augmented with new language about protecting electronic data, including data stored on cloud servers.
• Language in section 9.1 regarding Certificates of Confidentiality has been revised.
• Language in Section 9.1 regarding adult and child abuse has been revised to clarify who required reporters will include, for what Michigan law requires reporting, and a revision to the policies linked in the blue boxes.
• Help text on HIV testing has been both condensed and moved from what was formerly 11.2 (Which documents will I receive?) to section 4.1 (study procedures). The move was prompted by changes in Michigan law that no longer require researchers to provide subjects undergoing HIV testing with an informational pamphlet.

• In section 1.1 (key information), language regarding duration of study participation has been revised.
• Section 4.1 (procedures): This template instructs researchers to mark any procedures or risks included in the consent document but completed as part of standard clinical treatment with a “[not research]” tag. This is not required for all studies but can be used when research and standard clinical procedures overlap.
• Section 5.1: The passage beginning “Additionally, there may be a risk of loss of confidentiality or privacy” is new.
• Section 5.1 also now includes language pertaining to the risks associated with premedications.
• Section 7.2: The three-paragraph passage beginning “You are free to partially or completely end your participation in the study” is new.
• Language in section 7.2 regarding the risks of discontinuing study participation has undergone revision.
• Section 8.3 (“Who could benefit financially from information learned in the study?”) now contains prompt language researchers should use to disclose the source of funding for the University of Michigan study.
• Language about basic (non-HIPAA) privacy and confidentiality measures in section 9.1 have been added.
• Language to be added if adult or child abuse may be revealed during the study has been updated.
• 9.2: In the list of entities that may see subjects’ data, the bullet addressing use of research data by federal agencies and other entities for safety oversight purposes now closes with the phrase: “and for quality improvement purposes.”
• 9.2: In the list of entities that may see subjects’ data, the bullet about collecting subjects’ Social Security numbers has been revised by the Human Subjects Incentives Program (HSIP) to reflect their new expectations and policies. See also Research A-Z Payment to Research Participants, heading "Incentive," subheading "HSIP."
• The statement in section 9.2 about the expiration or termination of HIPAA Authorization has been revised. Representatives of the Compliance Office reviewed and approved these changes.
• Section 11: Language from a former orange box has been added indicating participants will receive a copy of the signed and dated informed consent document.
• The template’s signature section, formerly section 12, is now numbered Section 13.
• Signature boxes pertaining to optional aspects, such as unspecified future use and participation in sub-studies, were altered to contain yes/no boxes, but with a note instructing researchers to collect subjects’ signatures only when they select the yes box.

To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section. The new section 12 shifts the signature section to a new section 13.

• 12.1: Explaining the concepts of storage, use, and sharing.
• 12.2: Detailed description of each possible type of storage, use, and sharing, each enclosed in its own blue help text box, as follows.
• 12.2-A: Storage, future use, and sharing of information permitted by the revised Common Rule and applicable to most research under IRBMED oversight
  The language (previously in Section 4.4) has been updated to include a selection for industry sponsored or investigator-initiated research; all research submitted to IRBMED must include one of these two statements.
  This segment alerts potential participants that any data that have been used, placed in the medical record, or, in the majority of cases, shared with others cannot be retrieved and destroyed even if consent to their storage and use is withdrawn. See also Research A-Z Retention of Research Data/Biospecimens, heading "C. Retention for Future Research."
• 12.2-B: Storage, use, and sharing of data per NIH policy—both the data management and sharing (DMS) policy and the genomic data sharing (GDS) policy
  Language relating to the new DMS policy is new whereas language relating to the GDS policy was previously found in Section 4.1.
• 12.2.C: Storage, future use, and sharing of subjects’ data and/or biospecimens as a necessary condition of participation in the main study
  This language includes the caution that data may not be retrievable or destructible under certain circumstances.
  It also clarifies that subjects who withdraw consent to storage, future use, and sharing will be withdrawn from the main study.
  This language was previously found in Section 4.1.
• 12.2-D: Genomic data sharing in non-NIH-sponsored research
  This covers scenarios in which researchers are not obliged by policy to share genomic data but choose to do so.
  This language was previously found in Section 4.1.
• 12.2-E: Optional storage, unspecified future use, and sharing of subjects’ data and/or biospecimens
  The guidance prompts researchers to caution subjects that if they withdraw their consent to this optional activity, the researchers will attempt but may be unable to retrieve and destroy data and specimens that have been shared with other researchers.
  It also states that data and materials that have already been used in research, or data that has been placed within the medical record, cannot be retrieved and destroyed.
  This language was previously found in Section 4.1.