Amendments

Any changes to the study protocol, investigator brochure, consent form, study instruments, recruitment materials, and/or funding must be detailed on an Amendment form.  Additionally, any changes to the LPI, PI, Co-investigator(s) and/or study coordinator must also be reported to the HiREB using an Amendment form.

If, in the investigator’s opinion, these changes could affect a participant’s willingness to participate, or adversely affect the risk/benefit ratio, an amended consent form must be submitted and further enrollment must be halted until the investigator has written approval to continue.  In some cases, re-consenting of all study participants may be necessary.

• Advertisements (including social media) for recruitment purposes not submitted at the time of initial application must be approved by the HiREB prior to use.
• Any changes in reimbursements or incentives must be approved prior to implementation.
• Any planned inclusion/exclusion waivers or protocol deviations that are predicted should be submitted on an Amendment form.
• Any inadvertent deviation/violation must be reported to the HiREB on the Protocol Deviation form