Study Integrity

Whether returning results—or the timing of returning results—will impact study integrity should be considered on a case-by-case basis. Results may often be returned without compromising the research’s integrity or introducing bias.

Below are some general guidelines that can help inform an assessment of risk.

Timing of research tests and results

  • Baseline and end-of-study test results can generally be returned immediately without introducing bias
  • Tests performed during the study impact the study, depending on the type of test (below). Often, these results may only be returned after the study has ended.

Type of research test

  • If a result is one that participants could readily access outside of the study, and would not indicate the patient’s study arm assignment or drug response, it may be appropriate for return during the study
  • With the exception of urgent results, any test that may indicate the study arm assignment of a participant in a masked or blinded study, or that may motivate participants to leave the study early (either by suspecting assignment to placebo or in interpreting their results early or incorrectly), should be withheld until the study has ended.

If there is doubt about the impact returning a result will have on study integrity, return only after the study has ended.

Click here for additional guidance on timing and other aspects of return of individual results from the Secretary’s Advisory Committee on Human Research Protections (SACHRP)