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Writing a Consent Form

 

Below are some useful tips on writing a consent form for your proposed subject population. The procedures for obtaining consent should be documented on the Consent tab of the protocol application.

Coercion - The subject must be given the opportunity to consent or not consent without the intervention of any element of force, fraud, trickery, duress, coercion, or undue influence on the subject’s decision. Payments & credits should be pro-rated & not withheld until completion. Any payment or class credit must be appropriate to the tasks involved and the subject population.

Compensation - Compensation payments must be pro-rated or provided in full even if a subject withdraws from the study early. If the payment includes a lottery, participants must be at least 18 years of age to participate and be entered into the lottery and payment (e.g. prorating) cannot be withheld until the completion of the study. A participant may withdraw from a study and still be entered into a lottery. Approximate odds of winning need to be included in the consent form.

Class Credit - Any project where class credit is involved must be open to all members of the class AND there must be a non-research option to obtain the same credit for the same amount of effort. The Psych & Geography pools are currently the only pools at UCSB whose procedures are codified and do not need to be documented in this form. All other use of class credit & non research alternatives must be documented in the ORahs protocol application on the Consent tab.

Elements of Consent - Consent forms should include all the required elements of informed consent and additional elements (if applicable), unless a waiver of consent is requested, justified, and approved by the IRB.

Identifiable data - Consent for using identifiable data (e.g., video recordings) must be obtained, unless a waiver is requested, justified, and approved by the HSC. If participants are to be recorded or photographed, they must be informed as to how this media may be used (e.g., used in conferences, presentations, publications, shared with other researchers). The use of check boxes is recommended for varying levels of consenting to participate. If there are informational risks to the participant, additional safeguards may need to be put in place. These should be described in the risk tab and discussed in the participant consent. The disposition of identifiable data should be described in the consent form. Identifiable data may be retained indefinitely or destroyed. The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared.

Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population. This includes both reading level and language (e.g, English, Spanish, French). Field specific jargon should be avoided and all concepts should be explained in lay terms. For studies involving multiple subject populations (e.g., children and adults), multiple consent forms are required and must be tailored to the reading and comprehension level(s) of the subject populations to be enrolled.

Translation - If the subject population involves individuals who speak a different language, consent forms should be translated into the target language and translated back into English by two different individuals to ensure that the appropriate concepts are being conveyed. Using a translator app, such as Google translate should not be used to translate consent forms.

Other Helpful Hints -

Consent forms must be signed by the subject, and/or by the parent or legal guardian UNLESS a waiver of documentation or consent is requested, justified & approved. Signed consent forms must be stored securely in your UCSB Department. For information on requesting a waiver of documentation or consent, visit the Waiver of Consent or Documentation page.

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