Respect for the research participant is a fundamental moral requirement of human subjects research. Disclosure of information regarding the results of clinical trials in which participants are enrolled is essential to the informed consent process and to respect for participants. It is an ethical obligation of researchers.

On this basis, the Patient Advisory Board of the Coalition of National Cancer Cooperative Groups offers the following guidelines for all phase III clinical trials.

1. Disclosure to individual participants of the results of clinical trials, including early disclosure, will be the norm. However, disclosure must not violate any state or federal laws regarding breaking the code on anonymized data.

2. There are three scenarios for trial closure and notification, each with its own triggers and timeframes for notification:

Reason for Closure	OPS Notification Trigger	Site Notification (Time from Trigger)
Slow accrual	DMC decision announced	90 days
Adverse events or arm proven superior	DMC/DSMB decision announced	Patients under treatment: ASAP Patients off study: 90 days
Normal completion	Technical report release or interim results published	90 days

3. The individual who provided the original consent to participate in the research will be informed of the results of the clinical trial by his/her treating physician, or, absent the treating physician, by the institution's principal investigator of his/her designee, which may be an oncology nurse or data manager. If the participant was a child at the time of trial treatment but has reached the age of maturity at the time of trial closure, the participant should be notified of the closure directly by his/her treating physician or, when necessary, by the institution's principal investigator (PI) or his/her designee.

4. The treating physician or, when necessary, the institution's PI or his/her designee, should convey the following information to the trial participant:

   • The reason for the trial closure; the expected health outcomes; any change in the treatment plan
   • treatment decision(s) that must be made
   • follow-up required as a result of the new information.

5. The manner of notification ad the choice of the person to deliver it will be left to the judgement of the physician. At the discretion of the physician, participants may also receive a written copy of the information disclosed.

6. Any research participant or family member who is approached with the intent of sharing research results shall have the right to decline to receive any or all of the results of the clinical trial.

7. The information will be provided in lay terminology that is clear and understandable to the participant, with reference to any existing medical literature, and in sufficient detail to answer the participant's questions.

8. If the clinical trial is a Cooperative Group trial, the Cooperative Group office will provide the information in a format that is appropriate for patient use.

9. Notification of trial closure will be documented in the trial participant's research record, and the institutional IRB will be informed as a part of routine closure notification.