The Tufts Health Sciences Human Research Protection Program (HRPP) complies with all U.S. regulatory requirements related to the protection of human research participants. Specifically, the Tufts Health Sciences IRB complies with 45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, and 45 CFR 164.508-514. The ethical and regulatory requirements of the HRPP apply to all research involving human participants conducted on behalf of Tufts (regardless of funding or lack thereof) and to all individuals and components of the institution.
Federal and state regulations and institutional guidelines and policies govern human subject research. These regulations and guidelines exist to protect the rights and welfare of human subjects. If an investigator is engaged in research, IRB review and approval is required.
While there are no specific federal regulations addressing research involving incompetent or cognitively impaired persons, the highest ethical standards should be followed when conducting research with this vulnerable population. The OHRP IRB Guidebook addresses “special classes of subjects,” including fetuses and human in vitro fertilization, women, children and minors, prisoners, the terminally ill, the elderly, minorities, students, employees, and the cognitively impaired.
Specific federal regulations dictate the required elements of informed consent: 21 CFR 50 and 45 CFR 46. The IRB has developed informed consent form (ICF) templates.
A waiver or alteration of informed consent can be requested in accordance with 45 CFR 46.116(d) and 45 CFR 46.117. Those regulations allow for a waiver or alteration of the requirement for a signed ICF in certain minimal risk studies and when the principal risk is a breach of confidentiality. The FDA does not permit waivers of documentation of consent (see 21 CFR 50.23, 50.24). Please also note that a waiver of parental permission is not allowed for any FDA regulated research. To help determine if your research qualifies for a waiver or alteration of informed consent, call the IRB office at ext. 6-7512 or consult the Human Subject Decision Charts.