Physician Clearance Policy
Effective Date:02-02-2021
Revision Date:
I. Purpose
To provide a rationale for requiring physician clearance for certain participant populations prior to enrolling in a study, and describe all procedures associated with requesting physician clearance.
II. Policy Statement
In certain instances, the Institutional Review Board (IRB) may require researchers to request that an individual be “cleared” for participation prior to enrolling in a study. This step is most often required when the IRB is concerned for the safety of a subset of participants and mandates that certain individuals or class of individuals consult a medical professional, in most cases the individual’s Primary Care Provider, prior to being enrolled in a study.
III. Scope
There is no specific set of procedures in a protocol that may trigger the IRB to mandate physician clearance, the requirement will issue from the specifics of the study, the targeted population, and concerns arising during IRB deliberations. The IRB will inform researchers when the requirement to obtain a formal, signed physician clearance is a requirement for a protocol.
IV. Definitions
Physician clearance: A formal document signed by a medical professional attesting that an individual may safely participate in the study described in that document (please see attached Physician Clearance Template)
Physician: Unless otherwise noted, the IRB expects the physician to be the individual’s Primary Care Provider; however, physician clearance can be delegated to another medical professional duly authorized to provide medical advice, including a study physician.
V. Implementation
During the protocol review process, the IRB will communicate to researchers the need to acquire physician clearance for certain participants. The IRB will provide a Physician Clearance Template form which will be the only authorized manner in which the physician clearance will be recorded. Researchers will have the option of having potential participants approach their own physician(s) with the form and request physician clearance to participate in the research described. With participant permission, the researcher may also contact the physician(s) directly to request the signed clearance.
With regards to multi-year longitudinal studies, the IRB will request that researchers renew physician clearance annually. To clarify, researchers must request that the Physician Clearance form be signed by an authorized medical professional on an annual basis to ensure that participant are still eligible to participate in the longitudinal study.
Physician clearance is a requirement for participants deemed especially vulnerable by the IRB, as such, IRB representatives will have enhanced oversight of all studies requiring physician clearance.As part of the enhanced oversight, IRB representatives will conduct bi-annual either on-site or remote visits and request all physician clearance forms for review. The IRB retains the right to requests copies of physician clearance forms and other study materials at any point to ensure approved protocols are being adhered to for safety.
VI. Attachments
Physician Clearance Template