Documentation of Proper Informed Consent Procedures
Investigators are required to obtain informed consent from research volunteers according to the policies set forth by the Partners IRB and the Martinos Center for Biomedical Imaging. Only those persons authorized by an approved IRB protocol may obtain informed consent from research subjects. All research subjects are required to receive copies of their signed consent documents prior to participating in a research protocol. (A xerox machine is located in Bay 2 to facilitate this.) Subjects particpating in MR studies must also complete the MR screening form.
Signed copies of Consent Forms and MR Screening documents will be collected by the technical staff prior to scanning. Those scanning during non tech-supported hours are responsible for getting these documents to the technical staff promptly.
Based on consent and screening documents and other previously collected documentation of IRB approval the Imaging Core staff will check that:
- Consent forms are not expired
- Consent forms are signed and dated by appropriate parties
- Subjects meet inclusion/exclusion criteria for age, gender, subject type
- Subject has initialed the screening form indicating that he/she received a copy of the consent documents
- Study is not over the enrollment limit
- Imaging protocol used does not deviate from procedures approved by the IRB
In addition, we recommend that investigators print a number of consent forms equal to the number of subjects that they have been approved to enroll, and that they number their consent forms accordingly (e.g. 1 of 20, 2 of 20 ... 20 of 20).