Informed templates

New with the revised Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information that will help potential participants understand why they might or might not want to be a part of a research study. The image below displays the five elements identified in the preamble to the revised Final Rule as suggested key information. Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level.

A best practice is to have a colleague or friend read the informed consent document for comprehension before submission with the IRB application. 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.

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. FIUResearch Tweets by fiuresearch.

Adult Written Informed Consent. For this reason, providing additional information is not only an ethical but also a logical choice. Include your contact details on the form: It is only natural that the volunteers have questions about the clinical trial. By adding your contact information to the form, you will build trust with the participants. Enable automated email option for the submissions: Sending a copy of the informed consent form to the participants can be helpful if they want to re-read the terms later.

And this way, they will know that their submission has been successful. Back-up the form records: Informed consent documentation is one of the important elements of informed consent forms.

While conducting the research or after finishing the research you may need these records. For this reason, backing up the responses on your device, or printing them either individually or as a list can prove useful in the future.

Choose forms. Create online forms By using forms. Powerful features: Conditional logic Create forms with ease Calculator for exams and quote forms Geolocation restriction Real-time data Detailed design customization. Share or embed your form You can share your forms in any way you like. Also refer to the UM library system's plain language medical dictionary for more lay terms.

Special thanks to the Center for the Advancement of Clinical Research for contributions in the material below. Contact us at irbmed umich. Skip to main content. Provide information about the research in language the subject can understand. Encourage questions and query for understanding. Note that for children see Guidance about children and for those who do not understand written English language documents, this requires additional steps which require IRB approval.

Provide an explanation of the difference between treatment and research. Provide time for subjects to consider all options. The riskier the study, the more time that is usually required. Provide answers to all of the subject's questions before the decision is made.

Provide documentation about the research including calendars, instructions, etc. Note that the regulations do not require the subject's copy to be a signed copy, although a photocopy with signature s is preferred.

All materials provided to subjects need IRB approval. Provide on-going opportunities to re-affirm consent throughout the study. Remind the subject about important information. Provide new information as it becomes available.

Ask the subjects if they still want to participate. Document these interactions. Alternate text for many sections is provided in the instructions to tailor the document appropriately for the type of study being described. The federally required elements of consent are also provided. Use multiple consents tailored for each study group in unblinded studies where different subject groups undergo significantly different procedures or schedules. Use subheads within sections that require extensive detail.

Use a logical order for the topic within each section.