Public Health SC082: Research Ethics

Question 1

Clinical research

Answer 1

Conducted to evaluate the **safety + **efficacy of new pharmaceutical agents, or medical devices, in anticipation of widespread use by the general public

It involves:

1. Sponsor = the company that normally initiates it
2. Investigator = The person who carries it out

Question 2

Good Clinical Practice (GCP)

Answer 2

Who should adhere to:
Any research using human subjects demands the highest level of scientific rigor and ethical conduct. The roles and operating procedures is known as Good Clinical Practice (GCP)

GCP sets the standards for all aspects of clinical research. These standards have a two-fold goal:

1. The protection of human subjects
2. The maintenance of the highest standards of scientific practice

Development of modern GCP guidelines:
- Began with Nuremberg Code of 1947

GCP principles should be used in all 4 stages of Clinical Trials:

• Phase 1: Clinical Pharmacology (is it safe in normals)
• Phase 2: Controlled clinical trials (does it work)
• Phase 3: Expanded clinical trials (is it better)
• Phase 4: Post-marketing studies (will it have any long term results)

10 basic principles of GCP:
1. The sponsor’s overall clinical development plan must be **well crafted
2. Each study must be designed in accordance with sound **scientific principles
3. The **rights and safety of subjects must be protected by external review and approval of proposed procedures
4. **Consent to participate in the study must be informed and freely given
5. The study must be executed in conformance with accepted regulatory **guidelines
6. The study must be **monitored by the sponsor or its delegate for compliance with the guidelines
7. The data must be complete and **accurately reflect
information in source documents
8. There must be complete **accountability for test articles, their storage and final disposition
9. Proper **record keeping and record retention practices must be followed
10. A plan of **quality assurance must be in place and
implemented throughout the study

Question 3

IRB / Ethics committee

Answer 3

Ensure the investigator complies with GCP
- began with 1964 the Declaration of Helsinki

International Conference on Harmonization (ICH) has issued a set of guidelines intended to meet the regulatory requirements of all major governments:
- To standardize GCP guidelines worldwide

Ethics committee is NOT involved with research involving animals; that is done by another committee (CULATR)

HKU Faculty of Medicine:

• There is a now a combined HKU HA ethics committee / institutional review board) that comprises members from the Faculty, a non-faculty member and a representative from the HA.
• The committee reviews over 150 protocols a year in circulation as well as face to face meetings. The 3 commitment is to adhere to the Principles of Helsinki and also to the ISH-GCP guidelines. The investigator must ensure that a proper informed consent is signed.

Question 4

Routine FDA audit on what can go wrong

Answer 4

1. Inadequate consent form
2. Inadequate and inaccurate records
3. Inaccurate drug accountability
4. Failure to adhere to protocol
5. Failure to keep IRB informed of changes