200213P - CASE SCENARIOS IN RESEARCH ETHICS

Presentation at  The Faculty pf Medicine, Princess Noura University held on February 13, 2020 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board, King Fahad Medical City.

GIFT AUTHORSHIP

Case scenario 1 

• Marwa submitted a research proposal at her university and it was approved. She carried out the research and wrote the manuscript. Her friend, Abeer, attending another university read the manuscript and was impressed and asked to be included as a co-author. Marwa objected that Abeer had not contributed to the research, Abeer responded that she would reciprocate by including Marwa as a co-author in a research manuscript she was planning to write and submit for publication. 

PLAGIARISM OF IDEAS

Case scenario 2 

• During lunch, students were discussing possible research projects. Aisha listened to several ideas from her friends. When asked by her professor to submit a research project. She included many ideas from the students but she did not acknowledge the source. 

PLAGIARISM OF TEXT

Case scenario 3 

• Maha was writing a proposal to study the relation between salt intake and hypertension. While doing her literature review she found a paragraph in a paper on the same topic that stated exactly the research objectives she had in mind. She decided to include the paragraph as is in her proposal but forgot to put it in inverted commas and mention its source. 

PLAGIARISM OF TEXT BY PARAPHRASING

Case scenario 4 

• Nada submitted a proposal to IRB. The plagiarism detection software discovered that the text was copied (cut and paste) from a published paper. IRB rejected the proposal. Nada worked on the proposal by paraphrasing it (using different words or phrases) and resubmitted it for approval. Since the words were hers she did not see any reason for mentioning the source. 

see any reason for mentioning the source.

DATA FABRICATION

Case scenario 5 

• Fatima was undertaking a study on the correlation between weight and height and had recorded the data directly on an excel sheet. By mistake, she deleted the weight data of the 4 girls. She could not go back to get data from them because she did not know who they were; she had not recorded their names for confidentiality. Not willing to have a paper with missing data, she decided to insert weights at random and went on to publish the paper 

RESEARCH WITHOUT CONSENT

Case scenario 6 

• Shamsa had IRB approval for a study to find the relation between sleep disturbances and time spent on the mobile phone among students in her class. Over a period of 1 month, she asked each of them about her sleep and phone use as part of the routine conversation and would rush after that to complete the questionnaire. She never told any of the girls that she was carrying out research. 

HIDING BAD RESULTS

Case scenario 7 

• Maryam was repeating a research study that had been carried out overseas and had shown that drug A was effective against early morning fatigue that affected students. Her results however showed that the drug made the fatigue worse and she doubted her work. She decided to hide the results for fear of being ashamed 

RELATIONS WITH THE PHARMACEUTICAL INDUSTRY

Case scenario 8 

• A company producing drugs for the management of hypertension has offered to pay the part-time salary of a nurse in a doctor's practice. The nurse's role is to audit patients' records, ensuring that those with hypertension are regularly examined and receive up-to-date medicine. The doctor thinks this enhances patient care. The nurse provides anonymous patient data to the company but is barred from promoting its products. Information about the company's drugs is regularly provided by a sales team, which visits the practice and pays for working lunches with the doctor. A good relationship exists, and the company provides occasional gifts and invites the doctor's staff for dinner. 

USE OF PLACEBOS IN RESEARCH

Case scenario 9 

• A new drug that had proved effective against leukemia in animal, in vitro and phase 2 trials was submitted for human trials. Its risk profile was not well understood from earlier studies. It was to be tested against a placebo. There was no known effective treatment for this disease. 

ALTERATION OF A PROTOCOL WITHOUT IRB APPROVAL

Case scenario 10 

• A physician was given a fat grant to study a new drug. The sponsor provided a well-written and detailed protocol. Implementation of the protocol was difficult in the local circumstances: the subjects found the informed consent information overlong, and they could not adhere to the visit dates fixed in the protocol. The physician made alterations in the protocol that he thought were simple and did not affect study validity or patient safety, and saw no reason to inform IRB/REC. The sponsor sent monitors, who discovered the discrepancy. The physician ignored their observations and continued the study without documenting the changes he had made.

CONFLICT OF INTEREST FOR IRB MEMBERS

Case scenario 11

• The IRB of a major hospital sat to consider a proposal sponsored by a multi-national pharmaceutical firm, and 5 of the 6 members declared their interests. The Chairman had been engaged as a temporary consultant for the firm over the past 5 years, mainly to give lectures on drug development processes to potential researchers. The son-in-law of the deputy chairman had shares worth SAR 1,000 in the firm. One member was the brother-in-law of the principal investigator. The principal investigator, a member for 6 years, had not attended the meeting. Only one member had no interest to declare. The committee proceeded to consider the proposal because everybody's interests were now known.

HIDING UNFAVORABLE CLINICAL TRIAL DATA

Case scenario 12 

• A professor of cardiology conducted a well-designed, 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 and EU. 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. Analysis of the complete data confirmed the preliminary analysis. The professor decided not to submit the results for publication for fear of his reputation, and to avoid disturbing other cardiologists in the country who were satisfied with the drug. 

SIGNING CONSENT WITHOUT INFORMATION

Case scenario 13 

• A physician was recruiting patients for a large multi-center 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 were bored reading through or listening to the details and were ready to sign because they trusted the physicians doing the study. 

PRE-MATURE TERMINATION OF A CLINICAL TRIAL

Case scenario 14 

• A multi-center trial of a new medication was carried out at a local hospital; the hospital was among the last to join the 5-year trial. Local results showed that the drug was effective and patients were satisfied. Interim analysis of the data by the sponsor showed the superiority of the new drug. The sponsor also noticed that if the results of the local hospital were eliminated, the sample size of the remaining sites would be adequate. He, therefore, decided to terminate the study at the hospital prematurely and cut off the supply of the drug. 

VACCINE TRIAL WITHOUT VOLUNTARY CONSENT

Case Scenario - 15 

• A new vaccine against flu was found effective overseas. The Ministry of Health wanted to test its efficacy by a randomized study. Because of a negative media campaign, there were no volunteers for the study. The Ministry decided to force all hospital employees above 50 years to enter the study in the next winter season. 

RESEARCH WITHOUT IRB APPROVAL

Case Scenario - 16 

• A very experienced professor of surgery wanted to undertake research comparing two surgical approaches that he has been using alternately over the past 15 years. He reviewed the Nuremberg and Helsinki declarations as well as the ICH-GCP guidelines and the Saudi regulations on research. He made sure he fulfilled all stipulations of these documents in his research and saw no reason to seek the approval of the local IRB that in his view consisted of young inexperienced members most of whom had been his students. (SCHS) 

SENDING PATIENT DOCUMENTS TO SPONSORS OF RESEARCH

Case Scenario - 17 

• A physician in a local hospital agreed to be an investigator of a multi-center international trial sponsored by the pharmaceutical company. He regularly completed and sent CRFs to the sponsor overseas. On one occasion the sponsor questioned the data submitted and insisted that the original patient’s chart be shipped to him for inspection and verification. (SCHS) 

PRESCRIBING FIR THE SAKE OF RESEARCH

Case Scenario - 18 

• The hospital received a big grant 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 had already been found to be effective and was safe. (PEER Handbook SCHS 2014)