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Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

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Page 1: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Retha Britz Copyright 2013 All rights reserved for this presentation1

Background of bioethics & history of research

guidelines

Retha Britz

Page 2: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Nuremburg Code (1947)

Gruesome experiments conducted by Nazi doctors in German concentration camps during WW II

22 doctors found guilty of research misconduct during the Nuremburg Trial

Nuremburg Code followed as a result 10 principles:

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Page 3: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Nuremburg Code (1947) (continue)

Voluntary IC is essential Experiment to be for the

good of society Based on animal studies Avoid physical & mental

suffering and injury Pts to be protected against

injury, disability and death

Weigh risks against benefits No expectation of death or

disability Human experimentation to be

conducted only by scientifically qualified individuals

Pts can terminate involvement Investigators can terminate the

experiment if injury, disability or death is likely to occur

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Page 4: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Some research still conducted without IC despite strict requirement for it in the Nuremburg Code

Thalidomide studies in late 1950s to determine safety and efficacy as a sedative

Also used by pregnant woman 10,000 - 20,000 infants globally with severe teratogenic/neuropathy side effects

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Page 5: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Declaration of Helsinki (1964)

World Medical Association published DoH DoH superseded the Nuremburg Code DoH objective: Interests of science and

society do not take precedence over well-being of research pts

Revised 8 times (latest version is 2008) 2008 version currently under revision [2014]

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Page 6: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Declaration of Helsinki (2008)

Research physician to protect the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of personal information of research pts

Research must conform to generally accepted scientific principles: based on animal experimentation

Appropriate caution exercised in conduct of research that may harm the environment

Study protocol should be available Protocol submitted to a research EC before study commence Research only to be conducted by individuals with appropriate

scientific training and qualifications

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Page 7: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Declaration of Helsinki (2008) (continue)

Research in disadvantaged/vulnerable population is only justified if research is responsive to health needs and priorities of this population benefit from results

Assessment of predictable risks and burdens benefits should be foreseeable

Trials to be registered in a publicly accessible database Research physicians to be confident that risks involved have been

adequately assessed and managed Important that the objective outweigh the inherent risks and burdens Voluntary participation Protect privacy of research pts and confidentiality of their personal

information Pts to be adequately informed of all aspects of the trial

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Page 8: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Declaration of Helsinki (2008) (continue)

Consent given for collection, analysis, storage and/or reuse of identifiable human material or data

No pts in a dependent relationship with the investigator or consent under duress

For incompetent potential pts, consent to be obtained from the legally authorized representative

In case the incompetent potential pt can give assent, the physician should seek assent in addition to consent of the legally authorized representative. Dissent should be respected

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Page 9: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Declaration of Helsinki (2008) (continue)

In case physical or mental incapability is a necessary characteristic of the research population, IC to be obtained from a legally authorized representative or EC IC asap from pt or representative

Authors, editors and publishers all have

ethical obligations with regards to the

publication of the research results

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Page 10: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Bioethics (1932-1972)

US Public Health Services conducted a syphilis study in Tuskegee to determine the natural Hx of untreated syphilis

400 African-American men with syphilis were pts 200 without syphilis served as controls Pts were recruited without IC Pts were told that they are treated for “bad blood” and was

left intentionally untreated Transport was provided to and from clinics Hot meals were provided at the clinic

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Page 11: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Bioethics (1932-1972) (continue)

Free medical care for any disease other than medical care Pts were offered a free funeral policy if they agree to a post

mortem Pts not aware that they are in a research study 1945: Penicillin was found to be effective against syphilis, but

it was never offered/administered

Study was revealed in the New York Times

on 26 July 1972

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Page 12: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

The US Government (President Clinton) formally apologised to the pts and their families in 1997

74 of the untreated pts were still living

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Page 13: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Belmont Report (1979)

Autonomy, Beneficence & Justice

based on Principle-based ethics (moral theory)

US follows Belmont Report [acknowledge DoH]

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Appearance of Various Guidelines

1970s: FDA Guidelines and IND Regulations 1980s: National Codes - European countries 1990: Japanese GCP Guidelines 1991: European GCP Guidelines to improve the

process for developing and registering new medicinal products

USA, Europe and Japan Regulatory Authorities and Pharmaceutical Companies plus observers from Scandinavia, Australia, Canada and the WHO held a series of meetings to develop a set of GCP that would facilitate the universal acceptance of clinical trial data

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Page 15: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

ICH GCP (1996)

April 1996 was the International Conference on Harmonization (ICH) of Technical Requirements

for Registration of Pharmaceuticals for Human use

ICH GCP

Purpose of ICH GCP:

To provide a unified standard to facilitate the mutual acceptance of clinical data by the Regulatory

Authorities

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Page 16: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

What is GCP?

“A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that

provides assurance that the data and reported results are credible and accurate

and that the rights, integrity and confidentiality of trial subjects are protected”

SA GCP Glossary p.89

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Page 17: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Ethics in Health Research: Principles, Structures and Processes (2004)

Contain the SA National Policy on specific needs in SA and aims for “enhancing the dignity of South African citizens”

Intended to be followed by investigators of clinical research, RECs, administrators, health care practitioners, policy-makers and community representatives

The NHA section 72(6)(a) mandates that REC uses this “blue book”

2004 version currently under revision by the NHREC

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Page 18: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Guiding Principles as per “Blue Book”

Respect and dignity Relevance of the research Scientific integrity Investigator competence Principal Investigator

responsibility Informed consent Privacy and confidentiality In- and exclusion criteria Risk and benefits

Publication of results Conflict of interest Safety monitoring Multi-centre studies Standard of care Placebo-controlled studies Ethical review Distributive justice

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Page 19: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Ethics in Health Research: Principles, Structures and Processes (2004) (continue)

Section 4: Ethics Committees Composition and appointment of members Procedures Monitoring Suspension/discontinuation of research Reports to the NHREC etc.

Section 5: Research requiring additional attention

Minors Vulnerable communities Prisoners etc.19

Page 20: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

SA GCP (2006)

1st ed. published in 2000 Based on ICH GCP and other guidance documents such

as DoH (2004) Differences between ICH & SA GCP e.g. section on

Informed Consent Mainly for researchers conducting clinical trials No separate guidelines for other researchers conducting

research on/with human Includes composition of RECs, functioning and

monitoring by RECs

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Page 21: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

“”Clinical trials" means a systematic study, involving human subjects that aims to answer specific questions about the safety or efficacy of or method of treatment.” NHA, Section 72 (7)

“An investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other

pharmadynamic effects of an investigational product, and or to identify an adverse reaction to an investigational

product and/or to study absorption, distribution, metabolism and excretion of an IP with the objective of

ascertaining its safety and/or efficacy.” ICH GCP 1.12, p.3

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Page 22: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

CIOMS Guidelines (1982)

Council for International Organizations or Medical Sciences Guidelines

Intend to apply DoH in developing countries Specific attention to large-scale vaccine trials and

medications Includes section on compensation for injuries related

to research Shortcomings: Lacks separate section devoted to

risk-benefit ratios

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Page 23: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Other useful guidance documents

International Review Board (IRB) Guidebook. Office for the Protection from Research Risks – National Institute of Health, USA, 1993

World Health Organisation 2000. Operational Guidelines for Ethics Committees that Review Biomedical Research. Geneva

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Animal Research

MRC Guideline Book 3: Use of animals in research and training (2004) prescribes: Ethical principles involves Ethical code of behaviour for researchers,

educators and animal care staff Human obligation/duties A legal mandate for animal studies Ethical review process for animal research

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Page 25: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

Animal Research (continue)

Replacement: of sentient animals with non-sentient research models or systems

Reduction: of numbers of animals in experiments by design strategies that facilitates the use of the smallest number that will allow valid information to be obtained

Refinement: of animal sourcing to minimise or remove physical or psychological distress

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Page 26: Retha Britz Copyright 2013 All rights reserved for this presentation 1 Background of bioethics & history of research guidelines Retha Britz

References

DHAI, A., CLEATON-JONES, P. & TSOTSI, N. 2011. The ethics of research. (In Dhai, A. & McQuoid-Mason, D., eds. Bioethics, human rights and health law: principles and practice. Claremont: Juta. p. 166-170.)

MOODLEY, K. 2011. Research ethics and scientific integrity. (In Moodley, K., ed. Medical ethics, law and human rights. Pretoria: Van Schaik Publishers. p. 317-337.)

SCHÜKLENK, U. 2005. Module one: introduction to research ethics. Developing world bioethics, 5(1):1-13.

WORLD MEDICAL ASSOCIATION. 2008. Declaration of Helsinki. (59 th WMA General Assembly, Seoul, October.) http://www.wma.net/e/ethicxsunit/helsinki.htm Date of access: 21 May 2010.