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The Spectrum Health IRB has provided the following templates for use by the research community. A protocol is required to be included in all IRB submissions.
Informed consent is an active process through which investigators provide research volunteers with the information that they need to make informed decision to join a study.
The Spectrum Health IRB has provided the following templates for the research community. The templates include instructions on how to use the template, what is needed, or required, in each section of the form with additional template language for special topics.
When writing consent documents, it is advisable to start with the Spectrum Health IRB documents and add in information from another sponsor-provided template. Avoid using jargon and advanced technical or scientific terms in the consent document. Research volunteers from all backgrounds need to be able to read and understand the document. The Spectrum Health IRB will review consent forms to ensure that the forms are well-written, include all the required regulatory elements, and that the information is presented in order to facilitate understanding.
For clinical trials and studies that are greater than minimal risk (GTMR).
For interactions and interventions that are minimal risk (e.g., sample collection, surveys, social-behavioral studies, etc.).
For enrolling adolescent participants.
For use when the IRB has waived the requirement to obtain a signature for consent for a verbal or electronic survey.
For use in Single IRB studies or when the IRB requires a separate HIPAA form.
For use when participants will receive compensation or payment.
This template can be used for studies determined to be Exempt that are seeking consent for participation in-person or over the phone.
This template can be used for studies determined to be Exempt that are seeking consent for participation via email (e.g., survey studies sent via email to participants).
This template can be used for studies determined to be Exempt that are seeking consent for participation in an online survey.
The following worksheet is provided to help guide study teams when conducing Electronic Informed Consent (HRP-335). This worksheet provides details on what to submit to the IRB for electronic consent review.
For use when treating a patient with an investigational drug, biologic, or device (not a research study or clinical investigation).
The following short forms are provided to the research community to enroll participants who cannot use the standard form, have limited English proficiency or are non-English speakers. If an investigator plans to include non-English speakers in their targeted population, translation of the standard form is recommended and may be required by the Spectrum Health IRB.
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