We are developing oncology products, several of which will be targeted at a specific mutation/biomarker.  We want to create a “pre-screening protocol” to screen patients for this mutation, and then just identify them with permission to recontact them when we have a study open for people with that mutation.  Does the informed consent document have to include all the required elements of informed consent? 


This is a common question as we see more therapeutics in development in which the patient population is identified based in a specific genetic mutation or biomarker, and for studies of rare diseases.  The FDA released guidance about screening tests prior to study enrollment in 2017.  According to this guidance, the performance of laboratory tests and other screening tests for eligibility in a study is considered research: “Clinical screening procedures for research eligibility are considered part of the subject selection and recruitment process and, therefore, require IRB oversight.” Unless the procedure is being done as part direct care or treatment, the FDA requires approval by the IRB of the pre-screening activities and requires informed consent of the subjects prior to testing.

The IRB may approve a screening protocol and informed consent process, separate from the consent process for a specific clinical study. The screening consent form must include a description of the tests, why the testing is needed, and a brief summary description of the study or type of studies in which the patient may later be asked to participate. In its July 2017 guidance on waiver or alteration of informed consent for research involving no more than minimal risk, FDA asserts that, the when the IRB determines that the screening tests pose no more than minimal risks to subject, the IRB may allow changes to or omissions of the required elements of informed consent. 

The FDA notes that physician-investigators need to take care to be sure that prospective participants in the study are informed that the tests are being performed solely to determine eligibility for the study. The informed consent process should also make clear to the prospective participant that, based on the test results, they may be excluded from participation future clinical trials.

In those instances where the screening activities involve no more than minimal risk or involve procedures for which written consent is not normally required in the clinical care setting, the IRB may waive the requirement for the participant to sign the screening consent form. However, the WCG IRBs will require a signed document in those cases where the patient is in direct contact with an investigator prior to the screening procedures.