03 Summary Ethics in Research Aug 2011 - Copy.ppt
- 2. Ethics in Research • Research: a class of activity designed to develop or contribute to generalizable knowledge • Generalizable knowledge consists of: theories, principles or relationships or accumulation of information on which they are based • Ethics : a general term for the immaterial values, norms & attitude In research ethic has two part: Research ethics Researcher’s ethics ( Scientist’s personal honesty) 2
- 3. Ethics in Research • Main concern is ensuring fundamental principles: Respect for persons /autonomy Beneficence and Non Maleficence & Justice • These principles are essential regarding human right dignity & well-being 3
- 4. Ethics in Research … • A research can be approved if it is both ethically & methodologically sound • Ethical Review committees ( ERCs) are formed to protect the human subject • ERCs shall ensure that researchers have thought of ethical issues, specifically no: Harm will be done Resources will be wasted in the name of research 4
- 5. Ethics in Research … • It should be understood in the mind of investigators, that risks in health research undertakings, do not out weigh potential benefits. • Research ethics gives more emphasis that the well- being of research participant should take precedence over the interest of science Eg: Genetic studies • ERCs stand on the side of study participants to protect their rights, dignity and benefits 5
- 6. General objectives of ethics in research • To safeguard the study participants from any harm discomfort or risk related to research. • To assure that individual/ community benefits and civil rights are being respected and fairness is maintained. 6
- 7. Specific objectives: • To safeguard the participants from any harm, risk, discomfort (physical, emotional, psychological, social) • To ensure participation is voluntarily with written informed and signed consent • To monitor and evaluate ongoing and post research implications on participants and the community at large 7
- 8. Specific objectives… • To clear the way for legal consideration against research projects undertaken prior to ethics approval and unethical implementation of project • To regulate sample /specimens transfer • To monitor and evaluate ethical implementation of projects 8
- 9. Specific objectives… • To ensure the scientific and ethical standards of research projects. – A research project that is not scientifically (methodologically) sound is not ethically sound • To ensure justice to research participants (their rights are not breached, they themselves or the society is benefiting) 9
- 10. • All the above objectives boil to the three basic ethics principles: 1. Respect for persons/autonomy 2. Beneficence (principle of none-maleficience) 3. Justice. 10
- 11. I. Respect for persons 1. Autonomy • Protecting multiple and interdependent interests of the person (bodily, psychological/emotional, and cultural integrity) ►The investigator should respect each participant as a person capable of making an informed decision regarding participation in research study 11
- 12. 2. Informed consent • The importance of informed consent in research is unquestionable & should be analyzed in terms of three basic elements: Information Comprehension and Voluntarism 12
- 13. • The information shall be given in writing and signed by the participant • If the informed consent is that of a third partly, the reason for the indirect approach shall be stated in the proposal • To give informed consent, participants should get adequate information: What the study entails to the individual It should be expressed in a language that is understandable to the participant 13
- 14. • The consent information (under participant information sheet and a consent form) should indicate the following and written/translated to appropriate local language addressing the participants: a. Participant information sheet: A short introduction Title of the research/study/project Purpose/ aim of the research Procedures on the participant & its duration Foreseeable risks /discomforts and expected benefits to participants & or community at large. Includes compensation to possible injury/expenses claimed by the participant Confidentiality of information provided Rights of the participant Full address of the PI and the appropriate ethics monitoring body 14
- 15. b. Consent form: Then declaration of voluntary consent that states in the participants own terms that he/she is given full information about the research and the right to withdraw. This will only be certain if the participant is voluntary to sign. • Consent form should clearly indicate that the participants are free to withdraw • Participants are not also obliged to respond to all questions in the study Eg. Sensitive questions 15
- 16. 3. Confidentiality • Researcher shall assure that information that has been obtained in the course of investigation remains confidential to protect participants from possible harm at revelation of such information. • The privacy of a participant needs to be kept throughout the investigation 16
- 17. II. Beneficence • Persons are treated in an ethical manner not only by respecting their decisions & protecting them from harm, but also by making efforts to secure their well being • Such treatment falls under the principle of beneficence and none maleficience 17
- 18. • Beneficence is often understood to cover acts of kindness or charity that go beyond strict obligation • Two general rules have been formulated as complementary expressions of beneficent & none maleficient actions: Do no harm Maximize possible benefits & minimize possible harms (90/ 10) • Risk in research participant may extend from physical to psychological harm. 18
- 19. • IRB makes sure that the risks are at possible minimal level & benefits from the study outweigh the risks • Individuals participating in health research are benefactor of society • They take risks for the gain of information which may solve the problems of society at large • Thus it is necessary to give these participants their due respect 19
- 20. III. Justice It is about: Who ought to receive the benefits of research Fairness in distribution of benefits & burdens of research • Demands equitable selection of participants 20
- 21. • Protecting vulnerable groups (prisoners, children, pregnant woman, immuno - compromised…) • Injustice arises when selecting participants only from a specific socio-economic class, age, sex, racial, cultural & institutional make-up • When a research is absolutely necessary appropriate justification should be put in place with beneficial predicted outcome 21
- 22. 22 Source: National ethics guideline; 2005
- 23. Research ethics in Ethiopia In 1995, Ethiopia developed National Health Research Ethics Review Guidelines key objectives of the guidelines: • To develop capacity of researchers in health research ethics • To serve as a guide for the various ERC (institutional, regional and national) ►However, there are challenges in applying the guidelines 23
- 24. Role of ERCs in promoting local ethical standards • Safeguarding the right, dignity & welfare of study subjects • Verifying scientific & ethical soundness of protocols • Fostering research that is of benefit to the community • Proving adequacy of qualification of investigators • Ensuring availability of standard laboratories • Validating how samples are collected, transferred & stored • Demanding of consent for stored human samples 24
- 25. What the IRC requests • Well reviewed and written proposal (following standard guideline); a scientifically organized document addressing the following major contents: • Cover title • Aknowledgment • Table of contents, tables and figures (as appropriate) • Acronyms and abbreviations • Abstract/summary 25
- 26. • Introduction (with the following sub-topics) – Background (general information towards the issue to be studied: general to particular) – Problem statement (Why the research is important, what is the gap, what is new to be investigated: clear justification/ rationale of the need for this study…) – Significance: Who can ultimately use findings of this study and how? – Objectives: General and specifics • Literature review: Pertinent information from peer reviewed journal articles organized under pertinent sub- titles showing methods used and findings by other researchers and finally formulating a conceptual framework. 26
- 27. • Methodology (clear and detailed) Study area and study period Study design Source population Study population Inclusion and exclusion criteria Sample size determination and sampling technique Data collection methods Variables (dependent and independent) Operational definitions Data quality control 27
- 28. Method of data analysis (software to be used and statistical analysis methods and data presentation methods) Ethical considerations Methods of dissemination of information Expected limitations Work plan (detail using Gantt chart) Budget breakdown (detail and summary) List of references (following standard/recommended guidelines 28
- 29. Participant information sheet and informed consent form (with translation to pertinent local languages) The data collection instrument/tool (with translation to pertinent local languages) Other annexes (as found necessary) Curriculum vitae of the PI 29
- 30. Other things the PI has to be aware of: •Advisor approval signatures •Proper understanding of the National Ethics Guidelines and Bio-ethics guide 30
- 31. Other pertinent information • Studies regarding HIV/AIDS except KAP studies and studies on vulnerable population groups shall be approved by National Health Research Review Committee after passing Institutional approval. • No research should be advanced on issues involving human subjects without certificates from IRBs (or IRERCs.) • Ethical committees should be free from external pressures. • Ethical committees are expected to make follow-up research progress. 31
- 32. • Change of protocols in part or full should be verified by the IRBs (IRERCs) before implementation • Copies of final reports should be submitted to the IRBs (IRERCs) • The act of proper referencing (citations) and Acknowledging (plagiarism) • Consent should be obtained (as applicable) for personal/client records in health institutions even for secondary data or waiver requests should be asked from the appropriate ethical review committees. 32
- 33. 33 Thank you so much !