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Presented at a lecture for Clinical Research Coordinators held at King Fahad Medical City, Riyadh on Sunday, July 11, 2021 at 2:00-3:00. By Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board
7 CRITERIA OF ETHICAL CONDUCT OF CLINICAL TRIALS BY EMANUEL et al.:
INFORMED CONSENT: BASIC ELEMENTS:► Value: what is the social or scientific value of the drug or device tested?
► Scientific validity: will the methods used result in valid and reliable results?
► Fair selection of participants: is there discrimination in the selection of participant e.g. women, children, minorities?
► Favorable benefit/risk balance: are risks minimized? Do benefits outweigh risks?
► Independent review: is the approval process by an independent IRB?
► Informed consent: The most important ethical issue. Did the participants give free, voluntary, informed consent that they can withdraw without having to give a reason?
► Respect for enrolled participants: rights and welfare of the participants.
INFORMED CONSENT: ADDITIONAL ELEMENTS:1. A statement that the study involves research.
2. An explanation of the purposes of the research.
3. The expected duration of the subject’s participation.
4. A description of the procedures to be followed.
5. Identification of any procedures that are experimental.
6. A description of any reasonably foreseeable risks or discomforts to the subject.
7. A description of any benefits to the subject or to others that may reasonably be expected from the research.
8. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
9. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
10. For research involving more than minimal risk, an explanation as to whether any compensation and any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
2. Any additional costs to the subject that may result from participation in the research.
3. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
ETHICAL ISSUES IN THE PLANNING AND DESIGN STAGE:4. A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject. The approximate number of subjects involved in the study.
ETHICAL ISSUES IN THE CONDUCT OF CLINICAL TRIALS:► Ethics training: are all the study personnel trained in research ethics? Do they have a valid certificate of training in protection of human research subjects?
► Justification for as clinical trial: is the disease serious? Are there no other effective and safe treatments? Can we get the information needed from other types of studies? Will this study add anything significant to present knowledge?
► Randomization and fairness: the experimental group are exposed to risk while the control group may miss a useful treatment. What about use of the placebo?
► Conflict of interest: For the investigator or for the sponsor with harm to the participant?
► Informed consent: 16 elements, 12 basic and 4 additional.
ETHICAL ISSUES IN THE REPORTING OF CLINICAL TRIALS:► Trials in poor countries and communities: no local benefit, no proper consent, unnecessary risk.
► Recruitment: payment of participants beyond compensation of expenses. Biases in recruitment. Recruitment of vulnerable.
► Safety and Efficacy Monitoring: Data and safety monitoring committee and early termination of studies if dangerous or the answer is obtained.
► Privacy and Confidentiality: protection of personally identifying information. Special consideration for genetic information.
► Data Falsification or fabrication.
REFERENCE:► Publication Bias: positive trials more likely to be published quickly giving a false image of the reality.
► Suppression and Delay of publishing unfavorable results: sponsor influence.
► Conflicts of Interest and Publication: ghost authors, gift authors.
APPENDIX 1: Full Review Informed Consent Form► Lawrence M. Friedman; Curt D. Furberg; David L. DeMets; David M. Reboussin; Christopher B. Granger. Fundamentals of Clinical Trials. Fifth Edition. SPRINGER Switzerland 2015.
APPENDIX 2: Genetic Consent Form