Chapter 6 (Lesson 3)

Question 1

Ethical Considerations in Evidence-Based Practice (EBP)
A. Selecting and Using Intervention for a Given Patient
- Base decisions on the best available evidence for the patient, condition, and setting.
- Involve patients in choosing the intervention.
- Value research evidence more than tradition or expert opinion.
- Recognize the psychological and resource costs of using ineffective interventions.
- Avoid using data or results from unethical studies.

B. Participating in or Advocating for Research
- Monitor the ethical practices in any research you are involved in.
- Ensure complete and proper informed consent is obtained from participants.
- Advocate for research that balances survival and quality of life.
- Respect each participant’s autonomy and right to choose.
- Include consumers or patients in making important research decisions.

Question 2

_____ refers to a set of ethical and scientific standards that guide how clinical research involving human participants should be designed, conducted, recorded, and reported.

Its main goal is to ensure that the rights, safety, and well-being of research participants are protected, and that the data collected are credible and accurate.

The responsibility for following this is shared among everyone involved in the research process — including sponsors, investigators and site staff, contract research organizations (CROs), ethics committees, regulatory authorities, and even the research subjects themselves.

Answer 2

Good Clinical Research Practice (GCP)

Question 3

WHO PRINCIPLES OF GCP

Principle 1: ETHICAL BASIS – Research should be scientifically sound and conducted in accordance with basic ethical principles (Respect for Persons, Beneficence, and Justice) which originate in the Declaration of Helsinki.
Principle 2: PROTOCOL – Research should be scientifically justified and described in a clear, detailed protocol.
Principle 3: RISK IDENTIFICATION – Foreseeable risks and discomforts, and anticipated benefits for the subject and society should be identified.
Principle 4: BENEFIT-RISK RATIO – Initiated only if the anticipated benefits clearly outweigh the risks. The most important considerations are the rights, safety, and well-being of the trial subjects.
Principle 5: IEC/IRB APPROVAL – Research should receive independent ethics committee/institutional review board (IEC/IRB) approval prior to initiation.
Principle 6: COMPLIANCE – Conducted in compliance with the approved protocol.
Principle 7: INFORMED CONSENT – Freely given informed consent should be obtained from every subject. For incapable subjects, permission from a legally authorized representative should be obtained.
Principle 8: FAVORABLE PROFILE – Continued only if the benefit-risk profile remains favorable.
Principle 9: MEDICAL RESPONSIBILITY – Qualified and duly licensed medical personnel (physician or appropriate health care professional) should be responsible for the medical care and decisions of trial subjects.
Principle 10: QUALIFICATIONS – Individuals involved must be qualified by education, training, and experience, and currently licensed.
Principle 11: DATA HANDLING – All clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
Principle 12: CONFIDENTIALITY – Confidentiality of records that could identify subjects should be protected.
Principle 13: INVESTIGATIONAL PRODUCTS – Should be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practice (GMP) and used according to the approved protocol.
Principle 14: QUALITY ASSURANCE – Systems and procedures that assure the quality of every aspect of the trial should be implemented.