Research Consent

Informed consent is the process of telling potential research particpants about the key elements of a research study and what their participation will involve. The informed consent process is one of the central components of the ethical conduct of research with human subjects.

The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.

Informed consent process

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement.

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research.  IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Even in situations where the IRB may waive the documentation (signature) requirement (e.g., telephone interview, online survey), investigators are expected to present participants with the required key elements of informed consent and with a copy of the written consent document.

Informed consent documents and templates

We are in the process of updating our website. For the most up-to-date consent form templates, please refer to IRBNet. Forms should be available on the website in approximately 4-6 weeks as soon as all updates are made.
 

Interpretive services information

Study teams should submit the Interpretive Services Research Consent Translation form along with the research consent that needs to be translated. Once the translation is completed, Language Services will sign the form and return it along with the translated consent. The form can be submitted to: Translations@PrismaHealth.org

Interpretive Services Research Consent Translation Request Form