INFORMED CONSENT PROCESS AND FORMS

Compliance with the federally prescribed informed consent process is critical to the operation of any human subject protection program. However, compliance frequently is not achieved because the process is not sufficiently monitored, consent forms are treated as the process and for various other reasons. We can help you assure that the consent process will survive OHRP compliance oversight with the following services,

1. Review of your institution's informed consent process and forms with respect to consistency with Federal regulations
2. Development of standards for IRB review of proposed consent forms and IRB supervision of the informed consent process
3. Development of research personnel training programs pertaining to the informed consent process and preparation of consent documents