Bioethics: Research Regulation & Human Rights

• Bioethics relies on properly conducted scientific research.
• Bad science leads to bad ethics.
• Research can be unethical, leading to human rights violations.
• Research may ask the wrong questions.
• Over-reliance on pharmaceuticals may overshadow other important aspects of healthcare.

Research Regulation

• Biomedical research regulation emerged following post-WWII scandals.
• Scandals revealed researchers and funders neglecting participant risks.
• There is an agreement that research involving human subjects must undergo independent review per international norms.
• Key documents include the World Medical Association's Declaration of Helsinki, the Council for International Organizations of Medical Sciences and WHO guidelines, and the US government's Belmont Report and Common Rule.
• All documents emphasize participant protection as paramount.
• Independent ethical review, scientific validity, informed consent, and acceptable risk-benefit balance are essential.

Protection as Paramount

• Past failures include Nazi doctors' deadly experiments, US doctors failing to treat syphilis patients, and unethical cancer research.
• The Helsinki Declaration emphasizes that individual research subject well-being takes precedence.
• Scientific enthusiasm can overshadow researcher awareness of participant involvement.
• Consent may not be genuine when researchers exploit natural disasters or use food as inducement.
• Independent review of the research protocol is essential.

Independent Review

• The Helsinki Declaration mandates research ethics committee review prior to study commencement.
• Committees must be independent of researchers, sponsors, and undue influence.
• In the USA, ethical review committees are called Institutional Review Boards (IRBs).
• Maintaining independence and avoiding conflicts of interest can be difficult, especially with for-profit IRBs.
• The UK integrates ethics committees into the health service to prevent undue influence.
• Balance between professional expertise and lay involvement is crucial for committees.
• Consistency and quality of assessment across committees must be maintained.
• Ensuring adequate research ethics review in low- and middle-income countries is a significant challenge.

Scientific Worth and Validity

• Poor science equates to poor ethics, requiring research to be scientifically sound.
• Research Ethics Committees ensure scientific validity.
• Qualitative health research requires fair scientific assessment with appropriate expert reviewers.
• Research should genuinely gain new and beneficial knowledge.
• The worth of research is questionable when it produces 'me too' drugs with slight variations to circumvent patents.

Consent

• Justification of research relies on fully informed and genuine consent from subjects.
• Unlike treatment, research offers no definite benefit, leading to 'therapeutic misconception'.
• The Nuremberg Code emphasizes voluntary consent.
• Rigorous consent application makes health research impossible for children, cognitively impaired individuals, or those needing emergency treatment.
• Distinction between competent and non-competent subjects is necessary.
• Best interests are not applicable in research, as there's no obvious subject benefit.
• Risk to subject should be 'minimal'.
• Research should benefit that patient group (e.g., pediatric research improves pediatric care).
• Information given to competent subjects demands scrutiny from Research Ethics Committees.
• Information sheets are often technical and gloss over risks.
• Subjects in dependent relationships to researchers require ethics committee assurance of freedom to refuse or withdraw.
• Independence is assured by avoiding role conflicts (e.g., doctor and patient).

Balance of Risk and Benefit

• Ethics committees hold strong responsibility for assessing the risk-benefit balance.
• Research participation offers unlikely benefits.
• Potential for improvement in healthcare can still be a benefit, but it should be offered to participants.
• Ethics committees critically assess benefit-sharing with participants and their communities.
• Medical research involving disadvantaged populations is only justified if it addresses their needs and ensures benefit.

Risks

• Assessed for severity and probability, including physical and psychological risks.
• Pharmaceutical trials necessitate animal studies and trials on healthy volunteers before patient testing.
• Protect the research participant.
• Research cannot be authorized if committees foresee any serious risk.

Incidental Findings

• Ethical dilemmas arise when research uncovers information outside the study's focus.
• Incidental findings could significantly impact research participants.
• The finding could be inaccurate (false positive).
• Information release could cause unjustified anxiety.
• The person might not want the information.
• Genetic testing poses issues due to relevance to relatives and potential for employment, insurance impact.
• Difficulty assessing clinical significance of genetic factors, information relevance to relatives
• Guidelines are needed for researchers regarding information sharing.
• Obtain consent to ask if the participant wants to be informed of the finding.
• Need reasonably clear evidence that the finding is significant.
• Divulge the findings only if there are interventions to manage the health outcome.

Clinical Trials

• Involve patients as research subjects, employing randomized clinical trials (RCTs).
• Patients are assigned control and experimental groups in standard RCTs.
• The control group may get a placebo or standard treatment.
• Double-blind RCTs conceal treatment knowledge.
• A placebo may be an unacceptable risk and a genuine uncertainty is required.
• Commercial factors can drive trials.
• Ethical Inducements must be prohibited.

Use of Animals

• Some people believe there is no moral right to treat animals as our own means.
• There are several ethical views, some based on Buddhism and Animal Liberation or rational moral agency.
• Some try to minimise suffering inflicted on animals, and the number of animals used.
• Researchers often look to the 'four Rs': Respect, Reduction, Refinement, Replacement.
• Many consider that these measures aren't enough, arguing that animals provide poor models and we shouldn't treat non-human animals as though they had no rights to life.

Genetic Research

• Genetic information relates not just to the person whose genes are studied, but also to the family as a whole.
• There is a need to look at the combination of genetic and environmental causes.
• Can often be harmful because of prospects for health insurance or for employment.
• Poor science can result in stigmatising an entire ethnic group.
• What should be fed back to members and results?
• How will confidentiality be safeguarded?

Epidemiological Research

• Depends on seeing associations between large banks of data gathered over extended periods of time.
• It is very often quite impractical to seek consent from individuals because so many are dead
• The rights of individuals to privacy and confidentiality cannot be absolute if major social benefits are at stake.
• May mean putting thrust in the researchers, or to trust parties in order to go ahead in a well intentioned way

Research Integrity

• Depends on honesty and the truth being told at all times.
• Unfortunately, not all scientists bide by this principle.
• May be on the increase as more pressure is applied to make breakthroughs, or to promote one's career.

Fabrication

• Researchers have simply invented data to create a hypothesis for the report.

Falsification

• Images of data have been excluded that contradict the hypothesis.
• can also be achieved by employing deliberate inadequate or misleading statistical analysis.

Plagiarism

• Sections of another's person's work an be copies into an article or research report with no acknowledgment.
• Dishonest reviewers of the proposal or the submitted paper can get a head start and claim the work as original to themselves.

False Claims to Authorship

• Senior figure heads the research project and insists on being the author in all papers
• Proportion of input have to be clearly stated.
• Fraudulent authorship is 'gift writing' and 'ghost writing'.

Media Hype

• Scientifc findings get hype for the public media
• Authorities try to raise national prestige around the world by the publicity of the alleged

Future Perfect

• Enhance human health and worldwide-overcoming disparities.
• Human enhancement which will see utopian post-human.

Research Prioities

• The WHO reports a "10/80" gap.
• Several factors contributing to the gap
• Pharmaceutical industry is designed to maximise the return to shareholders.
• There is much less health benefit from massive expenditue.