Research informed consent template

The informed consent document should succinctly describe the research as it has been presented in the IRB application. The templates listed below include the new consent elements outlined in the Common Rule. If you choose to create an informed consent document without utilizing an IRB-HSBS template, you must ensure that all required elements are included and that the recommended language found in the templates is utilized appropriately.

Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e. New elements associated with the Common Rule are indicated in bold text. Word Blank template with revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.

It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval. For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools.

However, researchers are ethically bound to conduct a consent process with subjects. This template is suggested for use with Exempt projects. Word General outline to create and post a flyer seeking participation in a human subjects study. Includes instructions. Word Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.

Letters of cooperation must be on U-M letterhead and signed by an appropriate official. For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools. Phone: Fax: irbhsbs umich. Researchers must ensure prospective participants receive information about the study, sufficiently detailed to facilitate a truly informed choice, in a manner that facilitates voluntary consideration of whether to participate.

This ethical obligation exists for all research—exempt and non-exempt. Federal regulations outline informed consent requirements for non-exempt research, including a list of information participants must receive i.

Using one of the templates below helps ensure that your consent form includes these elements. The templates are only a guide. Templates can and should be adapted to fit the study plans and needs of prospective participants. However, all of the consent elements must be included in your consent form unless your study is eligible for exempt review. Consent forms must be carefully drafted to facilitate comprehension. The templates are revised frequently, so please visit this page prior to submitting any protocols to verify that you are using the latest template.

The first page of each form provides guidelines on completing the Informed Consent templates. Remember that your research population and proposed research may require special considerations.

Use the templates below to prepare your documents. This is required when accessing medical records for research purposes. FIU Florida International University is a vibrant, student-centered public research university, ideally located in Miami, that is worlds ahead in its commitment to learning, research, entrepreneurship, innovation, and creativity so that our graduates are prepared to succeed in a global market.

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