Policy AD-300 Participation in Investigational or Research Activities Involving Patients 2021-06-14

Purpose

The purpose of this policy is to provide clear guidelines to protect the welfare of the patient and respect their rights during investigational or research activities which involve Westside Family Healthcare (Westside) patients, in accordance with accepted ethical principles, federal HHS regulations, and best practice requirements of The Joint Commission (TJC).

Additionally, this policy recognizes the particular importance and historical significance of protecting the vulnerable populations served by Westside during such research activities.

Policy

It is the policy of Westside Family Healthcare that any proposed investigation or research activities involving patients of Westside will be reviewed in advance for approval by the Chief Medical Officer (CMO) using the Investigational or Research Activity Application. If approved by the CMO, the Application must also be presented to the Quality Improvement Committee (QIC) for approval.  Once the Application is approved, it will be conducted in compliance with all relevant principles and federal regulations related to human subject protection.

Scope

All Westside Family Healthcare sites, staff, and patients

Definitions

Research – Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  (45 CFR 46.102(d))

Institutional Review Board (IRB) – IRB means an institutional review board established in accord with and for the purposes expressed in 45 CFR 46.

Procedures

The Researcher will:

• 1. Obtain written consent by an Institutional Review Board governed by Title 45 Code of Federal Regulations Part 46 with implemented provisions by the National Research Act of 1974.
  2. Complete an Investigational or Research Activity Application.
  3. Submit the completed Investigational or Research Activity Application and all associated documents to the Chief Medical Officer.
  4. Assume responsibility for any costs associated with data collection and compensate Westside Family Healthcare appropriately for any Westside employee time associated with the study.
  5. Provide Westside with a copy of specific questions that may be asked of participants in the study, if applicable.
  6. Prior to initiation of the activity, complete appropriate forms with Human Resources, including a review of HIPAA and Westside patient privacy policies, if not already completed.  
  7. Ensure proper patient confidentiality in accordance with all relevant regulatory standards.

The Chief Medical Officer will:

• 1. Review all Investigational or Research Activity Applications.
  2. Request review by other staff members, as desired.
  3. Weigh the risks and benefits to the patient and Westside by participation in the activity.
  4. Compare the proposed investigational or research activity to the mission statement, guidelines, and values of Westside Family Healthcare.
  5. Complete the Chief Medical Officer Review/Outcome section of the Investigational or Research, Activity Application.
  6. Forward to the Quality Improvement Committee for review if CMO approves and if the request involves investigational research or activities.

The Quality Improvement Committee will:

• 1. Review all investigational and research activity applications forwarded by the Chief Medical Officer.
  2. Weigh the risks and benefits to the patient and Westside by participation in the activity.
  3. Compare the proposed investigational or research activity to the mission statement, guidelines, and values of Westside Family Healthcare.
  4. Complete the Quality Improvement Committee Review/Outcome section of the Investigational or Research Activity Application.

Once the investigational or research activity has been approved, an appropriately trained individual will:

• 1. Help the patient determine whether or not to participate in an investigational or research by providing the patient with all of the following information:
     1. An explanation of the purpose of the activity,
     2. The expected duration of the patient’s participation,
     3. A clear description of the procedures to be followed,
     4. A statement of the potential benefits, risks, discomforts, and side effects, as applicable, and
     5. Alternative care, treatment, or services available to the patient that might prove advantageous to the patient, as applicable.
  2. Inform the patient that there will be no increase in cost for their care at Westside Family Healthcare.
  3. Inform the patient that refusing to participate in an investigational or research activity or discontinuing participation at any time will not jeopardize or negatively impact their access to care, treatment, or services unrelated to the research.

Obtaining Investigational/Research Consent from the patient

• 1. The following will be documented in the Investigational/Research Consent form:
     1. The patient received information to help determine whether or not to participate in the investigational or research activity.
     2. The patient was informed that refusing to participate in the investigation/research or discontinuing participation at any time will not jeopardize or negatively impact their access to care, treatment, or services unrelated to the research.
     3. The name of the person who provided the information and the date the form was signed.
     4. The patient's right to privacy, confidentiality, and safety.

When relevant to the provision of care, clear documentation of clinical research interventions will be included within the EMR.

References

1. Title 45: Public Welfare. Code of Federal Regulations. Part 46: Protection of Human Subjects (45 CFR Part 46). Revised January 19, 2017, and Amended January 22, 2018 and June 19, 2018. General Compliance date of January 21, 2019.

HHS Office of Human Resource Protections. 45 CFR 46. https://www.hhs.gov/ohrp/regulations-and policy/regulations/45-cfr-46/index.html

National Research Act of 1974 (Public Law 93-348)

The Belmont Report – Office of the Secretary, Department of Health, Education, and Welfare.  Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. April 18, 1979. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Relevant Standards from The Joint Commission (TJC):

• 1. RI.01.03.05 The organization protects the patient and respects his or her rights during research, investigation, and clinical trials. Elements of Performance 2 – 4.  The Joint Commission (TJC). Rights and Responsibilities of the Individual (RI), Comprehensive Accreditation Manual for Ambulatory Health Care (CAMAC), January 1, 2021.
  2. RC.02.01.01 The clinical record contains information that reflects the patient's care, treatment, or services. Element of Performance 4.  The Joint Commission (TJC).  Record of Care, Treatment, and Services (RC), Comprehensive Accreditation Manual for Ambulatory Health Care (CAMAC), January 1, 2021.