1. 7. Medical Ethics and research BMS 234 Dr. Maha Al Sedik Dr. Noha Al Said Medical Ethics

2. Outline: Case study. Responsibilities of the researcher, sponsor and patient. The research protocol and related documents. Ethics of research publication.

3. Case study Case 1: The commander of an army brigade ( فرقة ) asked the brigade physician to undertake research on causes sick leave. The physician took blood from all soldiers to look for their immune profiles. When some soldiers objected that they were not asked for consent, he told them he was following military orders.

4. Case 2: A physician was recruiting patients for a large study of myocardial infarction. The informed consent sheet was 10 pages long because there were many procedural details and adverse effects to disclose. Most of the subjects grew bored reading through or listening to the details, and were ready to sign because they trusted the physicians doing the study.

5. Case 3 : A physician in a local hospital agreed to be an investigator of a trial sponsored by a pharmaceutical company. He regularly completed and sent reports to the sponsor. On one occasion, the sponsor questioned the data submitted and insisted that the original patient's data be sent to him for inspection and verification.

6. Case 4 A hospital received money from a pharmaceutical company to do a post marketing survey on a new analgesic. After trial initiation, it was discovered that the physicians in the hospital rarely prescribed the drug. The principal investigator called a meeting of all physicians in the outpatient clinic, and asked them to start prescribing the drug so that the hospital would not lose the grant. He explained that the drug was safe, and had already been found to be effective.

7. Case 5: A professor of cardiology conducted a post marketing survey of a drug that had been marketed recently in Saudi Arabia, but had been marketed for over 10 years in the US. Preliminary results were against what many researchers had published, and even seemed illogical to him. He told the team of researchers to keep this information secret until the study was completed. The professor decided not to submit the results for publication to avoid disturbing other cardiologists in the country who were satisfied with the drug.

8. Case 6: Dr. R, a general practitioner in a small rural town, is asked to participate in a clinical trial of a new non steroidal anti- inflammatory drug (NSAID) for osteoarthritis. She is offered a sum of money for each patient that she enrolls in the trial. They assure her that the trial has received all the necessary approvals. Dr. R has never participated in a trial before and is pleased to have this opportunity, especially with the extra money. She thinks a lot.

9. Researcher Sponsor Patients

10. Responsibilities

11. Responsibilities of the researcher Searching for volunteer involved in the research. Making sure that all study procedures are typical as the protocol. Assuring that all volunteers gave free and voluntary informed consent. keeping all the study records. Providing progress and final reports to the IRB (Institutional Review Board).

12. Responsibilities of the sponsor To provide the investigational product. Funding of the study. Follow up and monitoring.

13. Responsibilities of the patient To follow the study procedures. To report any adverse events promptly.

14. The research protocol and related documents

15. Protocol The main document in research is the protocol. It must be a comprehensive and detailed guide to conduct the research.

16. It must contain: Introduction (should be short about one or two pages ) including the objectives. Background (Review of Literature) : In this section what is already known about the topic is written. Research methodology: a way to solve the research problem. outcome measures. The sample size. The written consent.

17. Ethics of research publication Researchers tend to submit positive findings for publication and suppress negative ones. ( Unethically ) In a few cases, these decisions may involve a conflict of interest when the sponsor make pressure over the researcher.

18. Conflict of Interest COI

19. Conflict of Interest (COI) issues When the sponsor of the study influences reported outcomes to make them favorable to the new investigational product. ( X ) The investigator, consciously or unconsciously, may produce results favorable to the sponsor, and receive financial rewards for this. ( X ) In some cases, the investigator may not seek material rewards, but may want recognition.

20. Reference: Professionalism and ethics. Handbook for residents.

21. Dr. Maha Al Sedik …… Dr. Noha Al Said