Bioethics in Human Diseases Related Research.pptx

Ethical Concerns:

Vulnerable - e.g. children, adolescent age, indigenous person, low income, pregnant women
Informed Consent
Task/Research should be Beneficence.
Utility - make best of scarce resources and quality of methods
Justice and Inclusiveness

1. Bioethics in Human Diseases Related Research Submitted by: Tashvinder Singh PhD Research Scholar Department of Human Genetics and Molecular Medicine Central University of Punjab, Bathinda. [email protected]

2. History of Ethical Concern (1932-1972) The Tuskegee Syphilis Study, sponsored by the U.S. Department of Health. Studied the effects of untreated syphilis in 400 African American men. (1939-45) Morally abhorrent research conducted by German scientists on concentration camps prisoners and Japanese scientists on Chinese prisoners of war. (1964) World Medical Association, Helsinki Declaration. Ethical principles for research on human subjects. Revised several times, most recently in 2001.

3. Continued, (1974) Congress passed the National Research Act, which authorizes federal agencies to develop human research regulations, e.g. 45 CFR 46, 21 CFR 50,54,56. (1990) W. French Anderson begins the first human gene therapy clinical trial on patients with ADA deficiency, a genetic disease that affects the immune system. (2002) The President's Council on Bioethics recommends that the U.S. ban reproductive cloning and enact a moratorium on research cloning.

4. Organizations and Ethical Reports focusing on Human Research Council for International Organizations of Medical Sciences (CIOMS) World Health Organization’s International Clinical Trials Registry Platform National Center for Bioethics in Research and Health Care U.S. Office for Human Research Protections.

5. Ethical Reports Protecting human subjects has been the subject of historic documents such as the Nuremberg Code, The Declaration of Helsinki, The Belmont Report, and guided by regulations such as the Common Rule The International Ethical Guidelines for Biomedical Research Involving Human Subjects.

6. General Regulatory Oversight in the USA Physical and psychological risks to subjects are minimized. Physical and psychological risks to subjects are reasonable in relation to anticipated benefits to those subjects and to the importance of the general knowledge that may reasonably be expected to result. Selection of subjects is equitable Informed consent will be documented appropriately.

7. Continued, purposes of the research, its expected duration, and the nature of any interventions/experiments anticipated risks and benefits of participation and the reasonable alternatives to participation in the research protocol confidentiality provisions relating to the research records any compensation and/or treatment available for research related injuries The right to not participate and to discontinue participation at any time without penalty.

8. Tissue Specimens The National Institutes of Health and the Centers for Disease Control and Prevention jointly issued a Consensus Statement on ‘‘Informed Consent for Genetic Research on Stored Tissue Samples.’’ August of 1999, the National Bioethics Advisory Commission published a report that looked at the uses of human biological materials and issued 23 recommendations. The collection of human tissue specimens for use in current, and especially in potential future, research protocols raises a panoply of ethical concerns about, among other things, consent and confidentiality. These ethical issues manifest themselves in a regulatory context.

9. Informed Consent The study uses leftover specimens; that is, remnants of specimens collected for routine clinical care or analysis that would have been discarded if not used in the study; The specimens provided to the investigator are accompanied by only minimal clinical information such as age, sex, and existing laboratory results; The specimens are not individually identifiable;

10. The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information; The individuals caring for the patients are different from, and do not share information with, those conducting the investigation. The study has been reviewed by an IRB.

11. Medical privacy requirements The Privacy Rule requires specific written permission from a patient before anyone may use or disclose ‘‘protected health information’’ (PHI) about that person for non-routine purposes such as research. PHI is defined as any ‘‘individually identifiable health information’’ transmitted or maintained by a ‘‘covered entity’’ (for example, a healthcare provider, health insurance plan, or data processing firm).

12. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)

13. Ethical Concerns for different Patients Vulnerable - e.g. children, adolescent age, indigenous person, low income, pregnant women Informed Consent Task/Research should be Beneficence. Utility - make best of scarce resources and quality of methods Justice and Inclusiveness

14. Thank You