MBChB, MD, MSc, MPH, PhD, SBGS Research Ethics Saleem Saaed Qader MBChB, MD, MSc, MPH, PhD, SBGS Consultant General Surgeon and Lecturer Director General Medical Research Centre, Hawler Medical University, Erbil Department of Surgery, Medical College, Hawler Medical University Department of Surgery, Rizgary Teaching Hospital, Erbil TMC Oct 2014 1

Ethics Body of principles governing right and wrong OR Reference to morals or the rules or standards governing the conduct of a person or the members of a profession

Protection of the Human Subject in Medical Research Cultural Mores Laws respecting Human Rights Professional Codes of Conduct Individual Conscience Research Ethics Committee “REC”

Why is research ethics necessary? To ensure responsible conduct in research To protect research participants To protect researchers

When is human research ethics review required? Required for all research involving human and animals Research involving human participants includes: Collection of information through from a living person Secondary use of data previously collected from human Use of identifiable private information of an individual Research involving human remains, cadavers, human organs, tissues and biological fluids, embryos or fetuses

When is human research ethics review not required? Some exemptions… Research about a living individual involved in the public arena (publicly available information) Research conducted using secondary analysis of datasets or coded samples - identity of participants unknown

Research Ethics Committees (REC) The main objectives are to review the proposals to: Maintain ethical standards in research Protect research subject/worker from any harm/exploitation Preserve the subjects rights, safety and dignity Provide reassurance to the public that this is being done Protect research workers from unjustified criticism

Ethical Issues Multiple submissions Redundant publications Plagiarism Data fabrication and falsification Improper use of human subjects and animals in research Improper author contribution

1. Multiple submissions Multiple submissions save your time but waste editors The editorial process of your manuscripts will be completely stopped if the duplicated submission are discovered Competing journals exchange information on suspicious papers (even between competitors) You should not send your manuscripts to a second journal UNTIL you receive the final decision of the first journal

2. Redundant publication An author should not submit a previously published paper to another journal, except in these conditions: 1. Published studies do not need to be repeated unless further conformation is required 2. Previous publication of an abstract during the proceedings of conferences does not preclude subsequent submission for publication, but full disclosure should be made at the time of submission 3. Re-publication of a paper in another language is acceptance, provided that there is full and prominent disclosure of its original source at the time of submission

3. Plagiarism “Plagiarism is the appropriation of another person’s ideas, processes results, or words without giving appropriate credit, including those obtained through confidential review of others’ research proposals and manuscripts ”(the Federal Office of Science and Technology Policy,1999)

4. Data fabrication and falsification Fabrication is making up data or results, and recording or reporting them Falsification is manipulating research materials, equipment, processes, or changing/omitting data or results

5. Improper use of human subjects & animals Experiments on human subjects or animals should follow related ethical standards, e.g. Helsinki Declaration of 1975, as revised in 2000 If doubt exists in accordance of the research with Helsinki Declaration, authors must explain the rationale for their approach and demonstrate the approval from the institutional review body

6. Improper author contribution Authorship credit should be based on 1. substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data 2. drafting the article or revising it critically 3. final approval of the version to be published. Authors should meet conditions 1, 2, and 3 Those who have participated in certain substantive aspects of the research project should be acknowledged or listed as contributors

Nuremberg Code (1947) Voluntary & Informed Consent Experimentation on humans had to be necessary and yield benefit that overweighed the risk Right to withdraw without penalty Subject must be protected against possible injury, disability, or death Research only conducted by scientifically qualified personnel

1979 Belmont Report Three ethical principles related to research on human subjects: Respect for Persons Individuals should be treated as autonomous agents Individuals with diminished autonomy need protections Beneficence Do not harm Maximum benefits/ minimize potential harms Justice Fair distribution of burdens/benefits of research

Declaration of Helsinki 1964 Potential benefits must outweigh hazards The need for informed consent A distinction between scientific and clinical research

Seven Ethical Pillars of Clinical Research Autonomy Beneficence Non malfeasance Fidelity Truthfulness Confidentiality Justice

Autonomy Consent Para 20 The subjects must be volunteers and informed participants in the research project Para 22 After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing

Beneficence Para 5 In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society Para 18 Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject

Non Malfeasance Para 16 Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others

Fidelity– duty of care Para 11 Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature Para 15 Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person

Truthfulness - Honesty Para 27 Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available

Confidentiality Para 21 Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject

Justice Para 30 Every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study Para 8 Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights

Para 10 ‘It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject’

Threats to the Principle of Respect Coercion Undue Inducements Exploitation

Coercion Requires the presence of a threat Perceived coercion in research can occur with Prisoners Students and staff Payment for research is not coercive: Payment is an offer not a threat

Inducement Offers that make people to do things they would not otherwise do: Acceptable Inducements: Free car wash with fill-up Usually monetary Medical/diagnostic services Results from MRI scan Knowledge of genetic testing

Undue Inducements Excessively attractive offers that lead people to do something to which they normally would object based on risk or other fundamental value (Dickert, 2004) Monetary inducement that alters individual’s decision-making process such that they underestimate risks Payments invalidates the consent process Undue inducements may make subjects to lie/ conceal information that, if known, would disqualify them from participation

Exploitation An exploitative transaction is one in which person A takes unfair advantage of person B (Wertheimer, 1999) There is always an ethical concern when recruiting from vulnerable populations: Poor; homeless Mentally ill Terminally ill Prisoners Students Staff

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