1. Ethical Guidelines For Clinical Research

2. Introduction  All research involving human subjects should be conducted in accordance with three basic ethical principles namely,  Respect for persons  Beneficence  Justice

3.  These principles have equal moral force, guide the careful preparation of proposals for scientific studies.  Their application may lead to different decisions or courses of action.  Application of these principles to research involving human subjects.

4. Respect for persons  Includes two fundamental ethical considerations.  a) Respect for autonomy (independence). Those who have concern about their personal choices should be treated with respect to their capacity for self-determination.  b) Protection of persons with impaired or diminished autonomy. Those who are dependent or weak be given security against harm or abuse.

5. Beneficence  The ethical obligation to maximize benefits and to minimize harms.  This principle gives rise to norms requiring that the risks of research be reasonable in the light of the expected benefits, that the research design be sound, and that the investigators be competent both to conduct the research and to safeguard the welfare of the research subjects.

6. Justice  The ethical obligation to treat each person in accordance with what is morally right and proper, to give each person what is due to him or her.  In the ethics of research involving human subjects the principle refers primarily to distributive justice, which requires the equitable distribution of both the burdens and the benefits of participation in research.  Differences in distribution of burdens and benefits are justifiable only if they are based on morally relevant distinctions between persons; one such distinction is vulnerability.

7. Vulnerability  "Vulnerability" refers to a substantial incapacity to protect one's own interests owing to such obstruction as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being a junior or subordinate member of a hierarchical group.  Accordingly, special provision must be made for the protection of the rights and welfare of weak persons.

8. History  Nuremberg Code, 1947  Universal Declaration of human rights, 1948  Declaration of Helsinki, 1964  International covenant on civil and political rights, 1966  Policy statement on ethical considerations involved in research on human subjects  Proposed international guidelines for bio-medical research involving human subjects.

9. Declaration of Helsinki,1964  Basic Principles  Conform to accepted scientific principles, adequate experimentation and scientific literature.  Clearly formulated experimental protocol  Conducted by scientifically competent & under supervision of medically qualified person  Risk vs. Benefit  Subject’s right to safeguard integrity  Accuracy of results in publications  Informed consent  Research protocol must contain statement of the ethical considerations involved

10. Principles of ICH-GCP 1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the declaration of Helsinki and are consistent with the GCP principles. 2. Before initiating a trial, the risks and inconveniences should be weighed and against the anticipated benefit for the individual trial subject. (Benefits should justify the risks).

11. 3. The rights, safety and well-being of the trial subjects are the most important considerations. 4. The available clinical and non-clinical information should be enough to support the trial. 5. Scientifically sound and described in clear, detailed protocol. 6. A trial should be conducted in compliance with the protocol that has received prior IRB/IEC approval.

12. 7. The medical care given to or decisions taken on behalf of the subjects should be the responsibility of a qualified physician/ dentist. 8. Trial should be conducted by qualified (educated, trained, experienced) personnel to perform his/her respective tasks. 9. Freely given informed consent should be obtained from every subject prior to trial participation.

13. 10. All trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. 11. Confidentiality should be protected in accordance with the applicable regulatory requirements. 12. Investigational products should be manufactured, stored and handled in accordance with the GMP. 13. Quality assurance protocols should be implemented for every aspect of the trial.

14.  CONFIDENTIALITY Safeguarding confidentiality of research data and identity of subjects.  COMPENSATION FOR ACCIDENTAL INJURY Financial assistance and medical aid.  MEDIA AND PUBLICATION RELATIONSHIP Accurate information without raising false hopes or unnecessary scare people.

15. Statement of general principles in the Indian scenario 1. Principles of essentiality 2. Principles of voluntariness, informed consent, community agreement 3. Principles of non-exploitation 4. Principles of privacy and confidentiality 5. Principles of precaution and risk minimization 6. Principles of professional competence 7. Principles of accountability and transparency 8. Principles of maximization of public interest and distributive justice 9. Principles of institutional arrangements 10. Principles of public domain 11. Principles of totality of responsibility 12. Principles of compliance

16. Ethical Issues  Informed consent  Informed consent of the subject Of all subjects Waiver by IEC to certain issues  Obligations of the investigator No restrictions to questions by subject No information regarding the study should be with held. Inform the subject before informing him/her. Signed form for evidence in presence of witness. Renew consent form in case of changes in protocols or new information.

17. Essentials of Informed Consent 14. Publications/ photographs 13. Risk of discovery of sensitive biological info. 11. Contact and identity of research teams 12. Future use of biological material provided 10. Freedom to participate / withdraw 9. Compensation/ treatment for Injury related to research or disability or death 8. Investigator responsibility 7. Confidentiality 6. Prevent use of biological sample 5. Risks involved 4. Alternatives 3. Benefits of the study 2. Duration of participation 1. Aims & Methods

18.  Compensation for participation  Inconvenience  Time spent  Expenses incurred  Medical services  Not as incentive (inducement)

19.  Selection of special groups as research subjects  Pregnant or nursing women Trials that are designed to protect or advance the health of pregnant/nursing women or foetuses or nursing infants and for which non pregnant/nursing women would be unsuitable. Research related to medical termination of pregnancy. Research related to prenatal diagnostic techniques.

20.  Children Only if cannot be carried out in adults Carried out after phase III clinical trials in adults Obtain consent from parent/guardian Risk-benefit ratio  Vulnerable groups Genetic studies Economically &socially backward groups Mentally challenged persons People with reduced autonomy

21. References  Ethical Guidelines for Biomedical Research on Human Subjects, ICMR New Delhi,2000;p7-24  ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6(R1), current step 4 version, June 1996;p9  Schedule Y  World Medical Association Declaration of Helsinki, 1964

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