RESEARCH-RELATED INJURY AND ADVERSE EVENT POLICY
Connections Counseling Psychotherapy LCSW PLLC
Policy status: Proposed for IRB review
Applies to: Research involving human participants conducted by or on behalf of Connections Counseling Psychotherapy LCSW PLLC
Effective date: Upon approval/adoption
Responsible person: Principal Investigator (PI)
1. Purpose
Connections Counseling Psychotherapy LCSW PLLC is committed to protecting the safety, welfare, privacy, and rights of people who participate in research conducted by the practice.
This policy establishes procedures for responding to research-related injury, psychological distress, adverse events, and unexpected problems involving research participants.
The policy is intended to supplement, not replace, the requirements of the reviewing Institutional Review Board (IRB), applicable law, the approved research protocol, and the informed consent document.
2. Scope
This policy applies to research involving human participants conducted by the practice, including research that involves psychotherapy participants, interviews, questionnaires, audio or video recording, review of clinical information, or other research procedures.
The policy applies whether an event is physical, psychological, social, privacy-related, or otherwise potentially harmful.
3. Definitions
Research-related injury
A research-related injury is physical or psychological harm that is caused by or is reasonably suspected to have been caused or worsened by, a research procedure or research participation.
Examples may include:
– significant psychological distress caused by a research interview or research questionnaire;
– unexpected worsening of symptoms directly attributable to a research procedure;
– a physical injury occurring during a research procedure;
– a confidentiality breach involving research information; or
– another unexpected harm reasonably related to research participation.
Routine symptoms or adverse reactions arising from clinically indicated psychotherapy are not automatically research-related injuries. The PI will evaluate whether an event is reasonably related to a research procedure, clinical treatment, or both.
Adverse event
An adverse event is an unfavorable or unintended occurrence affecting a research participant during research participation, whether or not it is caused by the research.
Unexpected problem
An unexpected problem is an occurrence that is not consistent with the information previously presented to the IRB or participants and that may indicate increased risk to participants or others.
4. Immediate Response
The safety of the participant takes priority over research procedures.
If a participant becomes significantly distressed or appears to be at risk:
1. The research procedure will be paused or stopped.
2. The PI/clinician will assess immediate safety.
3. Clinically appropriate stabilization and support will be provided.
4. The participant may be referred for additional clinical care.
5. Emergency services will be contacted when necessary to address an immediate safety emergency.
6. Research procedures will not resume until the PI determines that resumption is clinically and ethically appropriate.
No research objective takes precedence over immediate participant safety.
5. Research Withdrawal
A participant may withdraw from research participation at any time without penalty.
Withdrawal from research participation will not, by itself, result in termination of clinical treatment.
If the participant requests withdrawal, the PI will explain what will happen to research information already collected, consistent with the approved consent form and applicable IRB requirements.
6. Assessment of Possible Research-Related Injury
Following an event that may constitute research-related injury or an unexpected problem, the PI will document:
– what happened;
– when and where it happened;
– the research procedure involved;
– the participant’s symptoms or reported harm;
– immediate actions taken;
– whether clinical treatment was involved;
– whether the event was expected;
– whether the event was reasonably related to research participation;
– whether additional care or referral was needed;
– whether research procedures should be modified or suspended; and
– whether the event must be reported to the IRB or another authority.
The PI will avoid assuming that an event is either research-related or unrelated without considering the circumstances.
7. Clinical Care and Referral
When the PI is also the participant’s treating clinician, the participant’s clinical needs will be addressed independently of the research objectives.
If additional care is needed, the participant may be referred to another qualified clinician or service when appropriate.
The practice does not promise unlimited or automatic payment for medical or psychological treatment arising from a research-related injury unless such payment has been specifically approved by the IRB and stated in the informed consent document.
8. Costs and Compensation
Unless the IRB-approved protocol and consent form state otherwise:
– participants will not receive payment for research participation;
– ordinary clinical treatment costs remain the responsibility of the participant or the participant’s insurer, as applicable; and
– the practice does not maintain a separate automatic compensation program for research-related injury.
Nothing in this policy is intended to waive or limit any legal rights or remedies available to a participant.
If an IRB requires a specific research-related injury or compensation arrangement, the approved IRB language will supersede this document and this policy will be revised as necessary.
9. Reporting to the IRB
The PI will report adverse events, serious adverse events, unanticipated problems, protocol deviations, and other reportable events to the reviewing IRB according to the IRB’s reporting requirements and timelines.
If the PI is uncertain whether an event is reportable, the PI will consult the IRB rather than assuming that it is not reportable.
If an event suggests that the approved research procedures may pose greater risk than previously recognized, the PI will not continue the affected research procedure when continuation would create an unreasonable risk. The PI will consult the IRB regarding whether protocol or consent changes are required.
10. Corrective and Preventive Action
After a significant event, the PI will determine whether corrective action is needed.
Possible corrective actions include:
– modifying a research procedure;
– changing the distress-monitoring procedure;
– revising inclusion or exclusion criteria;
– increasing participant monitoring;
– revising the informed consent document;
– retraining research personnel;
– temporarily suspending enrollment;
– temporarily suspending a research procedure; or
– permanently stopping a research procedure.
Changes to an IRB-approved protocol will not be implemented as research procedures without IRB approval unless an immediate change is necessary to eliminate an apparent immediate hazard to a participant.
11. Confidentiality Breaches
A suspected or confirmed loss, theft, unauthorized disclosure, or unauthorized access involving research information will be treated as a potential adverse event or unexpected problem.
The PI will:
1. take reasonable steps to contain the breach;
2. assess what information was involved;
3. document the incident;
4. determine whether notification is required under applicable law, practice policy, contractual requirements, or IRB requirements; and
5. report the event to the IRB when required.
12. Documentation
Documentation concerning research-related injury or adverse events will be maintained separately from the research dataset when practical and will be protected as confidential information.
Documentation will be retained according to the retention period approved by the IRB and applicable law.
13. Participant Contact
Participants will be provided with contact information for:
Principal Investigator:
Ruth Campbell, LCSW, Ph.D.
845-255-5022
ruth@connectionscounseling.org
PO Box 1235, New Paltz, NY 12561
Reviewing IRB:
North Star Independent Review Board
info@northstarreviewboard.org
Participants may contact the PI or IRB regarding concerns about research participation, including possible research-related injury.
14. Relationship to Clinical Risk Management
This policy applies specifically to research participation. It does not replace the practice’s ordinary clinical risk-management procedures, emergency procedures, mandated-reporting obligations, or standards of clinical care.
When a situation involves both clinical care and research participation, immediate clinical safety takes priority, followed by assessment and documentation of the research component.
15. Review of Policy
This policy will be reviewed whenever:
– the IRB requires changes;
– a research-related injury or significant adverse event occurs;
– a material change is made to research procedures; or
– the practice begins research involving materially different participant populations or procedures.
The PI is responsible for maintaining the policy and ensuring that research personnel are familiar with applicable procedures.