1. Medical Research Ethics Dr. Alaa Gouda MSc
Medical Research Ethics Dr. Alaa Gouda MSc. ,FACCP, EDIC Assistant Consultant KAMC-ICU Managing Editor of Journal Annals of Thoracic Medicine

2. What is Research?
Medical research studies are designed to provide information on health or disease.
Medical research studies often aim to advance our knowledge of a medical condition.
Each study tries to answer specific questions.
Medical research finds new ways to treat and prevent disease.

3. Research is beneficial
Can bring benefits, good, better lives, safer lives…
No argument there.
Research is a good thing.

4. Research entails risks
No research is risk free
Some risks can be anticipated
Some risks can be mitigated
Some risks can be avoided
But because it is research we cannot anticipate all risks

5. Types of research
Observational studies follow the same group of people over time to find out what happens to their health.
Epidemiological studies look for patterns of diseases in large groups of people.
Intervention studies look at ways to change behaviors that affect health.
Prevention studies look for ways to keep people from getting sick.
Clinical trials are performed to learn the best ways to treat or, sometimes, to prevent disease

6. What is Ethics ?
Ethics:
The discipline of dealing with what is good and bad, with moral duty and obligation
A set of moral principles or values
The principle of conduct governing an individual or group

7. Research ETHICS
Research ethics concerns the responsibility of researchers to be honest and respectful to all individuals who are affected by their research studies or their reports of the studies’ results.

8. ETHICS in Research Valid research question Purpose ? promotion IRB
Data collection
Consent
Methodology , randomization
Writing , no plagiarism
Statistics
Honest conclusion
Submission and Publication process
Disclosure , funds
No bias at any stage

9. Unethical Examples
Breaking and re-breaking of bones ( to see how many times they could be broken before healing failed to occur)
Malignant melanoma study NEJM .
The Tuskegee Syphilis Study NEJM .
Milgram’s obedient study
Pfizer off label use of Gabapanthin 430 M $
“Stanford Prison Study” brutality among guards

10. The response
Nuremberg code
Declaration of Helsinki
CIOMS Statement
Tri-Council Policy Statement (Canada)
National Committee on Ethics in Human Research (Canada)
Belmont Report (US)
Office of Human Research Protection (US)
MRC guidelines ( UK)
British Sociological Society (UK)
Nuffield Reports (UK)
Research Ethics Boards

11. Nuremberg Code 1947 (10 principles)
Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity.
The experiment should aim at positive results for society that cannot be procured in some other way.
It should be based on previous knowledge .
The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries.
It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.

12. Nuremberg Code
The risks of the experiment should be in proportion the expected humanitarian benefits.
Preparations and facilities must be provided that adequately protect the subjects against the experiment's risks.
The staff who conduct or take part in the experiment must be fully trained and scientifically qualified.
The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on.
Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.

13. The Declaration of Helsinki World Medical Association (1964, 1975, 1983, 1989, 1996, 2002)
“The well-being of the subject should take precedence over the interests of science and society”
Consent should be in writing.
Use caution if participant is in dependent relationship with researcher
Limited use of placebo, especially if treatment is available
Greater access to benefit once research is concluded
Epi April 2008

14. Council for International Organizations of Medical Science (CIOMS) Guidelines 1993, 2002
Nuremberg => Helsinki => CIOMS
Informed consent
Research in developing countries
Protection of vulnerable populations
Distribution of the burdens and benefits
Role and responsibilities of ethics committees
Epi April 2008

15. The Belmont Report (The U. S
The Belmont Report (The U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978)
Ethical Principles and Guidelines for the Protection of Human Subjects of Research:
Respect –autonomy , Individuals should consent to participate in studies and those who cannot give their consent, such as children, people with diminished abilities, and prisoners, need to be protected.
Beneficence – promote good , minimize risks, and maximize possible benefits.
Non-maleficence The researcher not harm the participants.
Justice – fairness in procedures for selecting participants
Epi April 2008

16. APA Guide 2000
The researcher is obligated to protect participants from physical or psychological harm.
During or after a study, participants may feel increased anxiety, anger, lower self- esteem, or mild depression, especially in situations in which they feel they have been cheated, tricked, deceived, or insulted.
The general concept of informed consent is that human participants should be given complete information about the research and their roles in it before agreeing to participate.

17. Six Norms of Scientific Research
Valid research design – takes into account relevant theory, methods, and prior findings
Competence of researcher – capable to carry out the procedures
Identification of consequences – assessment of risks and benefits (maximizing benefit and minimizing risk)
Selection of subjects – appropriate to the purposes of the study, representative of the population that will benefit from the research and appropriate in number

18. Six Norms of Scientific Research
Voluntary informed consent – obtained before study begins, without undue threat or inducement, with enough information, and agreement to participate.
Compensation for injury – responsibility for what happens to
the subject .

19. Research in Humans

20. Justification of Research in Humans
If you’re going to treat humans, you must study humans
Impossible to reach the important conclusions without studying humans.
Human physiologic studies, because animal responses often are not the same
Epidemiological studies, because they depend on human susceptibilities and human interactions
Agents for treating humans because animal experiments don’t always predict results.
Epi April 2008

21. Guiding principles Autonomy and respect Beneficence Non-maleficence
Utility
Justice
Scientific validity
Honesty

22. Respect for Participants
Respect for autonomy and human dignity
Informed Consent
Honesty
Confidentiality fairly applied
Fair recruitment procedures
Follow up

23. Informed Consent for Research
Information…
Who is conducting and funding the study
What the study is about
What are the alternatives
What are the risks
What are the benefits
What if they want to withdraw Permission

24. Must be… Clear and meet the patient’s needs Honest as far as possible
Obtained in advance
Signed or recorded (unless waived by IRB)
Voluntary, not influenced
Allow time to ask questions and consider
Continual or repeated

25. Beneficence / Non-maleficence
Given that we will ask persons to take risks for the benefit of others we must do what we can do mitigate these risks and avoid them wherever possible
Duty to do good
Duty to do good research
Duty to anticipate and avoid harm
Balance Benefit and Risk

26. Assure That Benefits Outweigh Risks
Benefits must outweigh risks.
Researchers must protect participants from harm and maximize their well-being.
Risks or harms and benefits may be physical (pain or injury), psychological, social, economic, or legal.
Risks or benefits of research may apply to individual participants, families, groups or organizations, communities, or nations.
Epi April 2008

27. Utility Make best use of scarce resources
Research participants are a valuable resource
Ensure value of the research question
Ensure quality of method

28. Justice & Inclusiveness
Given that risks cannot be avoided altogether
But are justified because of the benefits research confers
Justice asks us to share the burdens and benefits of research fairly
Fair distribution of risks
Do not over burden participants
Fair distribution of benefits
Give everyone access to the benefits of being studied and of study outcomes

29. Now you decided to do a Research……

30. Clinical Equilibrium
This means that a researcher can compare treatments when: a. there is honest uncertainty about which treatment is best. b. there is honest professional disagreement among experts concerning which treatment is best.

31. Explain why and ensure understanding
Researchers often tell participants exactly what will be done in the study but usually do not explain why.
Simply telling participants about the research does not necessarily mean they are informed, especially in situations in which the participants may not be competent enough to understand.
Voluntary Participation: Participants may feel forced to participate or perceive that they have limited choice.

32. Deception
Passive deception ( or omission) is the withholding or omitting of information; the researcher intentionally does not tell participants some information about the study.
Active deception ( or commission) is the presenting of misinformation about the study to participants. The most common form of active deception is misleading participants about the specific purpose of the study.

33. Example 1. Asch (1952, 1965) To assure participant’s participation , they hide the side effect of a drug intentionally.
Example 2. Heine & Kitayama (2000)
To observe participants’ natural motivation toward a task, they videotaped the participants’ behavior using hidden camera.
Example 3. Masuda & Nisbett (unpublished)
They eliminate the title of the research which would have indicated that it concerns differences between Japan and the US. As a result the participants were unaware that their responses would be compared with those made by individuals in the other culture

34. Justified Deception
The deception must be justified in terms of some significant benefit that outweighs the risk to the participants. The researcher must consider all alternatives to deception and must justify the rejection of any alternative procedures.
E.g. Minor side effect of the drug for the significant benefits of the drug. (HIV example)

35. Debriefing / Confidentiality
The final point is that deceived participants must receive a debriefing that provides a full description of the true purpose of the study, including the use and purpose of deception, after the study is completed.
The APA ethical guidelines require that researchers ensure the confidentiality of their research participants.
Ensuring that participants’ records are kept anonymous. (how long you may keep the records ? )

36. The Institutional Review Board (IRB)
Each institution is required to establish IRB
The IRB is your friend
Element of peer review
Protects participants
Protects researchers ( Ethanol proposal )

37. During Conducting the research……..

38. To ensure accuracy of scientific knowledge
Fair subject selection
State clear research methodology
Should not falsify/modify/omit/fabricate data (Fraud)
Use actual data for analysis/cannot include someone else's data
Report errors
Be aware of conflict of interest
Should not withhold and/or ‘vaguing up’ information
Data and material should be available to others

39. Do not present/publish paper from incomplete research or from anticipated outcomes
Should not duplicate publications and submissions
Should be reviewed Independently by unaffiliated individuals
Citation and authorship
Whenever somebody else’s work is quoted , reference should be made to the original author .
Acknowledgement should include the names of person who helped

40. After you complete your research……….

41. Reporting of Research
Researchers do not fabricate data. (They do not make false, deceptive, or fraudulent statements concerning their publications or research findings.)
If they discover significant errors in their published data, they take reasonable steps to correct such errors in a correction, re-traction, erratum, or other appropriate publication means.
They do not present portions of another’s work or data as their own, even if the other work or data source is cited occasionally.

42. Fraud It is important to distinguish between error and fraud.
Fraud, is an explicit effort to falsify or misrepresent data.
A safeguard against fraud is peer review, which takes place when a researcher submits a research article for publication.
Replication is repetition of a research study using the same basic procedures used in the original to test the accuracy.

43. Plagiarism
You can literally copy an entire paper word for word and present it as your own work or you can copy and paste passages from articles and sites found on the Internet.

44. Remember Do not include names without participation in the research
Do not submit to many journals
No copy / paste
Do not manipulate data
Do not start before IRB approval
Conflict of interest/disclosure
Informed consent
Do not steal other’s work/ideas

45. Why should there be research ethics?
To protect participants /patients /society /resources /researcher?
To ensure accuracy of scientific knowledge
To protect intellectual and property rights

46. Thank You