Tip of the Month
Monthly research compliance reminders and information.
Explore our Tip of the Month Archive below.
May 2026
Is Your Study a Clinical Trial, a Basic Experimental Study Involving Humans (BESH), or an Observational study?
Accurate classification of a research study is critical for ensuring compliance with reporting requirements. Classification of a research study includes the following:
Clinical Trial
Involves assigning human participants to an intervention (e.g., drug, behavior change, or environmental exposure) to evaluate its effect on a health-related outcome.
Basic Experimental Studies with
Humans (BESH)
Focuses on understanding fundamental biological or behavioral processes without a direct health outcome goal.
*Effective for completing applications submitted for due dates on or after May 25, 2026, the NIH will no longer characterize BESH as clinical trials and will no longer be subject to NIH clinical trial requirements. For applications submitted for due date on or before May 24, 2026, BESH will continue to be treated as a clinical trial.
See NIH notice NOT-OD-26-027 for more information and guidance.
Observational Studies
Researchers do not intervene - data is only collected or analyzed (prospectively or retrospectively). These include natural history, secondary data, and repository studies. These are not clinical trials or BESH.
The table below can help determine research study classification
|
Human Participants? |
Prospective Assigned Intervention? |
Evaluate Effect of Intervention? |
Health-Related Outcome? |
Study Type |
|
Yes |
Yes |
Yes |
Yes |
Clinical Trial |
|
Yes |
Yes |
Yes |
No |
BESH |
|
Yes |
Yes |
No |
No |
Observational |
|
Yes |
No |
No |
Yes |
Observational |
|
Yes |
No |
No |
No |
Observational |
April 2026
Voluntary Participation 
Voluntary participation is a fundamental element of conducting ethical research and should be respected throughout the entire research process.
Key Aspects Include:
Informed Consent: Participants should understand the research study's purpose, risks, and procedures
before agreeing to take part.
Participants must be informed of new information that may affect their willingness
to continue.
Freedom to Withdraw: Participants can stop study participation at any time without negative repercussions, such as losing services or benefits.
Protection of Vulnerable Group: Special care is required to ensure that individuals with diminished capacity or in dependent relationships do not feel pressured to participate.
Absence of Coercion: Researchers must not use pressure, manipulation, or excessive undue incentives to force participation.
Respect for Autonomy: If a potential participant declines participation, additional recruitment attempts should not occur. Repeated approaches (email, phone, in-person) may undermine voluntary participation.
March 2026
Obtaining Adverse Events (AEs)
An adverse event is any untoward medical occurrence (or worsening of an existing condition) in research participants, which may or may not have a causal relationship with the study treatment.
When obtaining AEs from research participants several methods may be used to collect AEs. It is recommended to review all applicable methods and document identified AEs on an AE log.
Recommended Methods
Review of medical records, including physician and nurses' progress notes, procedure notes, and outside medical records.
Lab and test results deemed clinically significant should be assessed for potential AEs and if applicable, added to the participant's medical history.
Common FDA findings include failure to report or not adequately record AEs.
Upcoming event
FDA Inspections: Institutional Experiences
Tuesday, April 21, 2026 2:00pm
Join the Research Quality Compliance Network for a panel discussion featuring institutional leaders who will share practical insights and lessons learned from FDA inspections. This session will provide valuable perspective for research teams preparing for or navigating regulatory review.
February 2026
Documenting Eligibility
Eligibility should be reviewed and documented by the study coordinator and Principal Investigator (PI) or delegated Sub-Investigator (Sub-I), PRIOR to enrollment, and randomization. The following documentation practices are recommended:
Signature of the investigator to confirm eligibility criteria should ONLY be done after all eligibility criteria are confirmed. There should be no criterion pending prior to enrollment and randomization.
For therapeutic studies, all screening labs and/or imaging and diagnostic reports MUST be documented as reviewed by the PI or delegated Sub-I prior to enrollment and randomization.
January 2026
Participant Recruitment Methods
The IRB reviews all screening, recruitment, and advertising methods to ensure they meet consent and privacy requirements.
December 2025
FDA 1572
The FDA1572 form is a Statement of Investigator, a legally binding contract between a clinical investigator and the FDA and required for all clinical trials in which an Investigational New Drug (IND) application has been filed. The tips below will assist research teams with completion of FDA 1572 forms. Additional information can be found in UUSOP-16: Form FDA 1572.
- Ensure the current FDA 1572 version is used. Verify the expiration date before signature, check the FDA website for the latest form, and remember that an expired version doesn’t need to be replaced unless the information on the form changes.
- List all facilities where research procedures occur or where investigational product
is stored/administered (e.g., CTSI CRU, investigational pharmacy, PCH, University
clinics).
- Do not list individual locations within the main University Hospital.
- Do not include participant home addresses.
- List laboratories or testing facilities directly supporting the research, including
those collecting, processing, or shipping samples.
- Only list the main ARUP location (500 Chipeta Way); other ARUP sites are not needed.
- Include ONLY individuals with a permanent, protocoldefined role in treating or evaluating
research participants (e.g., physicians, PhD faculty, PAs, NPs).
- Clinical research staff or ancillary personnel (e.g., coordinators, regulatory staff, residents, pharmacists, infusion staff, office staff) do not need to be included.
November 2025
Assessment of Lab and Test Results
All lab, imaging, and diagnostic report results should be assessed in a timely manner by the Principal Investigator or Sub Investigator (Sub-I) listed on the FDA 1572 form. If applicable, the PI can delegate the responsibility to medically qualified Sub-I(s) on the Delegation of Authority Log.
Out-of-range values and/or abnormalities should be assessed and indicated to be Clinically Significant (CS) or Not Clinically Significant (NCS). The PI or Sub-I should sign and date each assessment.
Any results deemed Clinically Significant (CS) should be assessed for potential Adverse Event’s (AE) and if applicable, added to the participant’s medical history.
Under ICH GCP E6 (R2), PI’s are required to demonstrate oversight of a clinical trial. The review and assessment of lab and test results is one way to demonstrate PI oversight.