Informed consent template for research study

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.

General Consent Template : This form covers all of the basic elements that are required for a consent document. Even if you don't plan to use this exact document, refer to it to ensure that you have all of the appropriate elements in place in your consent procedure.

Electronic Consent Template : This form is modeled after the General Consent Template with some modifications that make it more appropriate for an online format. For more information about this template, see Electronic Consent. Parent Consent : If you are including minors in your study, you will need to provide a consent form for parents and an age appropriate assent form for minors.

This form is a guide for creating a parent informed consent document. This form can also be used as a guide for surrogate consent procedures. Minor Assent : This template provides the basic elements required for older minors to provide assent and could also be used as a model for higher functioning individuals with diminished mental capacity.

Minor Assent : This template provides the basic elements required for younger minors to provide assent and could also be used as a model for higher functioning individuals with diminished mental capacity. For children younger than 7, assent forms are not required but include information in the consent section regarding what you will say to them about the study where appropriate.

Consent or Notification no signature required. Study Information Sheet : While many studies do not require researchers to collected signed consent forms, we generally require that participants receive a Study Information Sheet to provide them with information about the study.

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. Parental Written Informed Consent. 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. For example, in the risk section, begin with research related risks that are expected, likely, and serious.

Conclude with rarely expected risks and convey the likelihood. Insert hard page breaks if the page breaks at a place that makes it hard for the reader to follow such as right after a subhead.

Do not use text smaller than 12 point. Use at least 1. Discuss only one or two ideas per paragraph. Keep paragraphs short. Avoid compound sentences. Use shorter, simpler words whenever they can convey appropriate meaning.

Define or explain medical terms, procedures, and technical or complex words. Use U. State 2 teaspoons rather than 10 MLs. Use regular time not military time. For example, say 1 p. Do not use exculpatory language, that is, language that indicates somebody the researchers or UM is free from blame.

Do not include highly scientific objectives or hypotheses that are of little relevance to the participants. These may bias your results or confuse participants. Consider what the participant would want to know.