- 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
- 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.
Changes to document body text
- 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.
New section: data and biospecimen storage, future use, and sharing
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.
When uploading your informed consent form in eResearch
- New Applications: Please make sure to delete all instruction boxes, comments, and headers from the original working template. Also be sure to proofread the document for spelling, grammar, and formatting errors.
- Amendments: Per the IRBMED Document Revision Guidance, Naming Convention, and Version Control statement of practice, as part of an amendment modifying the consent(s)
- Edit the most recent version of the CLEAN informed consent document found in 10-1.1.
- Turn on “Track Changes” feature in Word.
- Save “Track Changes” version in .docx or .doc format.
- Upload ONLY "Track Changes" document on the previous tracked-changes stack in 10-1.1 using the ellipsis (three dots) next to the version number column.
- Use the standard naming conventions for stacks from the Document Revision Guidance, Naming Convention, and Version Control statement of practice. Also be sure to proofread the document for spelling, grammar, and formatting errors.
