The IRB reviews the application and attached documents including (but not limited to) the research protocol, consent forms, scripts and recruitment and advertising materials, and payment arrangements. The IRB:
- Determines whether the consent process is appropriate for the proposed research activities and if revisions to the consent process or document are necessary.
- Determines the amount of payment and the proposed method and timing of disbursement is neither coercive nor presents undue
- Reviews the proposed research project and determines that the consent document accurately reflects the purpose, risks, benefits and procedures, and payments as outlined in the research protocol and contains all the required elements of consent
- Determines whether documentation of informed consent is appropriate for the proposed research activities, the subject population and the level of
The IRB will ensure that:
- The research application and related materials (i.e. recruitment/advertisement materials, payments, consent documents, scripts) as submitted to the IRB are approvable.
- Recruitment locations, recruitment methods, advertising materials and payment arrangements do not place subjects at risk of coercion or undue influence or cause inequitable
- The consent process minimizes the possibility of coercion or undue influence and maximizes continued legally effective informed consent. When prospective subjects are vulnerable to coercion or undue influence due to their status, condition or situational vulnerability, the IRB will ensure that the informed consent process is appropriate for that
- The consent document has the requisite regulatory and institutional information and is written in language that is understandable to the research project population.
- The consent documents accurately describe the risks and benefits initially approved by the IRB and at the time of research project modifications, continuing review, submission of reportable events or other safety-related
Significant new findings or alterations to the risks and benefits that may relate to the subject’s willingness to continue participation will be provided to the subject