How to Write a Consent Form for a Research Project

A consent document is typically used to provide subjects with the information they need to make the decision to volunteer for a research study. Federal regulations (45 CFR 46.116) provide the framework for the type of information (i.e., the “Items”) that must be included as part of the consent process. The novelty of the revised 2018 common rule is the requirement that the consent document begin with a “concise and focused” presentation of the most important information that helps potential participants understand why they may or may not want to be part of a research study. For the use of U-M Dearborn faculty, staff and students conducting research on unedited human subjects using a pool of subjects. Please allow at least 2 weeks for IRB review and approval. Plan ahead using the deadline indicated here when submitting new applications, continuation forms or amendments that must be reviewed and approved prior to the start or continuation date of your project. The actual schedule may vary depending on the schedule of the IRB meeting. Please call if you have any questions. Researchers who carry out data collection subject to the General Data Protection Regulation (GDPR) must use this template with a general consent template/document. (Word) Blank template with key common rule information revised in 2018 and other required consent elements presented as section headers; contains instructions and the recommended language. It is strongly recommended that you modify this template to create a project-specific consent document for your study for review and approval by the IRB. For a list of the basic and additional elements of the 2018 Common Rule, see the updated document on the basic elements of informed consent. Informed consent is the process by which potential research participants are informed of the key elements of a research study and their participation.

The consent process is one of the central elements of conducting ethical research with people. The consent process usually involves providing a written consent document containing the necessary information (i.e., elements of informed consent) and presenting that information to potential participants. Even in situations where the IRB may waive the documentation (signature) requirement (p.B. Telephone interview, online survey), auditors are required to provide participants with the necessary key elements of informed consent and a copy of the written consent document. The informed consent document should briefly and succinctly describe the research as presented in the IRB application. Highly recommended for studies that involve the collection of biological samples and/or genetic or genomic analyses, especially for government-sponsored clinical trials that require a certificate of consent to be published on a public website. In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., document consent to participate), unless the IRB has waived the consent requirement or documentation requirement (signature). The following figure shows the five elements identified as key information suggested in the preamble to the revised Final Rule. PDF.

Lists the basic and additional elements that need to be included or included, as appropriate, in the informed consent documentation, as well as the citation number [z.B. _0116(b)(1)] in the revised common rule. New items associated with the 2018 Common Rule are in bold. If you choose to create an informed consent document without using an IRB-HSBS template, you must ensure that all required elements are included and that the recommended language (included in the templates) is used appropriately. Note: Element number 5 (alternative methods) applies primarily to clinical research. The human subjects of your project must participate voluntarily because they have been sufficiently informed about the research. Appendix D – Sample Consent Form for Research With Greater than Minimal Risk OR Where Subjects Are NOT Anonymous Consent Form documents are not reviewed by the IRB for exempt projects. However, researchers are ethically required to conduct a consent process with subjects. This template is proposed for use with excluded projects.

(Word) Two letter templates for the site allow cooperation between U-M and other institutions, organizations, etc. Letters of cooperation must be affixed to U-M`s letterhead and signed by a competent official. These letters are uploaded to the Performance Site section of the eResearch IRB application. The IRB-HSBS strongly recommends that researchers use one of the informed consent models designed to include the required consent elements (as defined in 45 CFR 46.116) as well as other required regulatory and institutional formulations. The templates listed below contain the new consent elements outlined in the 2018 Common Rule. Informed consent documents must be written in plain language at a level appropriate to the professional population, usually at a grade 8 reading level. A best practice is for a colleague or friend to read the consent document to verify its comprehensibility before submitting it with the IRB application. Always: Routine fMRI study? Refer to the fMRI Guidelines to review the study criteria and download the IRB-HSBS fMRI consent template. A proposed addition to the Exempt Informed Consent Model is the IRB-HSBS Model Exemption Protocol.

For information and guidelines on informed consent waivers or educational consent documentation, please refer to the Waiver Policy. The IRB-HSBS General Informed Consent Model has been revised to include new “key information” and other elements required to meet the requirements of the 2018 Common Rule. Download the revised template for your use. Additional templates will be released as soon as they are updated to meet the new requirements. Appendix J – Example of an Ethnography Study (Completed Social Science Consent Document) Instructions on how to use plain language, examples and more can be found at: www.plainlanguage.gov/ (Word) Overview of creating and publishing a pamphlet to participate in a study with human subjects. Contains instructions. SAMPLE – Consent Form for the Use of Tissues in Research Exhibit C – Sample Cover Letter for an Anonymous Survey Exhibit F – Sample Parental Authorization Letter Thank you to the Department of Social Sciences for permission to use this example. Upload, edit and delete documents in eResearch.

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