Consent Form Instructions

Consent Form Instructions and Samples
Ethical research and respect for persons requires that all subjects be given adequate information to allow them to make an informed and voluntary decision whether or not to participate in the research. The following information includes all the required elements of informed consent needed and how to write an informed consent form. All elements of informedconsent should be present on surveys, interviews (both written and oral), and signed consent forms. Some survey research may not require a signed consent form, but needs to include all elements of informed consent. Informed consent must be sought from all prospective participants (or their legally authorized representative), unless waived by the Institutional Review Board (IRB). The IRB may waivethe requirement of a signed consent form if: a) the consent form is the only record linking the subject with the research and the principal risk would be a potentially harmful breach of confidentiality or, b) the research presents no more than minimal risk to the participants and involves no procedures where written consent is normally required outside the context of research. The informed consentmust include the following information: 1. 2. 3. 4. 5. 6. 7. 8. 9. A statement that the study involves research. A description of the procedures to be followed, its expected duration, the conditions of the subject’s participation, and an identification of experimental procedures proposed. The reasonably foreseeable risks and discomforts. The expected benefits of the research to the subject and tosociety in general. A description of the extent and manner which confidentiality of information will be maintained. An explanation as to the availability of compensation and the availability of treatment if injury occurs, except where the research involves no more than minimal risk(s). A contact person, phone number, and email address to which inquiries about the research project can be made. Astatement that participation is voluntary. A statement that no penalties will result from non-participation or withdrawal.

Extra Credit Participants may receive some type of compensation (i.e. course credit, a free service, money, etc.). However if teachers solicit their own students to be research subjects and extra credit is offered as compensation, there must be a fair alternative by whichstudents who do not wish to or cannot participate in the research study can receive the same amount of credit.

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Survey Research Survey research may not require a signed consent form if names are not personally identifiable with the data collection. It does require a cover letter or informed consent statement which, with theexception of the subject signature, contains all the necessary information for informed consent. The statement, “the return of this survey is your consent to participate in the research” should be at the end of the consent document in the place of a signature line. Vulnerable participants: Minors (under 18 years of age): If you use participants under the age of 18, a parent or legal guardian mustsign. If the child is old enough to give verbal consent, what is expected of the child should be explained in simple terms and verbal consent obtained. This process should be noted on the consent form. If the child can read and write then the child’s form has to be written at the level of the child’s understanding. Two forms may be used: a consent form for the parents and an assent form for thechild. They can be placed on the same page. Cognitively impaired or institutionalized: If a subject is cognitively or mentally impaired and it is questionable that he/she has the ability to understand so as to be able to give “informed consent” or “assent,” then the subject’s guardian, family member, or other person who is responsible to protect the participant’s welfare must sign. As with minors, if...