Poplhlth 204.14 Rights Research And Public Health

Front 1

What is the evidence of harm?

Back 1

• Flouridation can cause fluorosis (mottling and discolouration of teeth)
• Some suggestion that there is a possible association between fluoride consumption in water and bladder cancer
• Evidence of harms is contestable, just as evidence of benefit is

Front 2

When considering interventions look at:

Back 2

- Harm?
- Affect on public good- does it contribute to public good
- Does fluoride benefit worst off
- Right-any right being violated

Front 3

Why do research involving humans?

Back 3

• Medical research helps us to identify new treatments
• Medical research helps us to compare treatments in terms of efficacy or balance of benefits/harm
• Qualitative research helps us to identify the health problems that people face and to understand their impact. Qualitative research can also help us to understand how people interact with healthcare, what they want from a service, etc
• Epidemiological research helps us to understand the prevalence and distribution of a given condition within a community. This allows us to target services efficiently and effectively.
• Note: because of risks with research there is an incentive to free- ride: enjoy benefits of research without contributing to it.

Front 4

World Medical Association’s Declaration of Helsinki

Back 4

- Participation by competent individuals as subjects in medical research must be voluntary. ..
- no competent individual may be enrolled in a research study unless he or she freely agrees.
- ...After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing...

Front 5

Why is consent considered to be such an important pre-condition for medical research?

Back 5

• Respect for autonomy
• Welfare considerations
• Social support for research: predicated upon trust and a sense that research will not involve exploitation. Consent requirements promote trust.

Front 6

Research Without Consent

Back 6

- Possible to get approval without consent of consent impossible, impractical or will affect validity but only after consideration of ethics committee
- Some research like Large scale audit on non-sensitive procedure using anonymised records will have lower risk than Participation in a placebo-controlled RCT for life-threatening condition which has high- risk
- Generally, the higher the risk that an individual is exposed to, the more important it becomes to obtain their consent for that exposure.

Front 7

Justifying research without consent: 3 relevant issues

Back 7

• Risk: High risk: presumption of consent, Low risk: ? more likely to go ahead if risk to participants low
• Benefit- Prospect: magnitude and likelihood, Recipient: participant vs others. Research that provides certain more larger benefits with are likely to be approved without consent
• Method- Some methods require consent, Others can’t tolerate consent eg research that looks at natural behaviour

Front 8

How to decide if a research is ethically acceptable?

Back 8

To answer this, it is necessary to consider the following:
• What were the risks attached to the research contributions?
• What was the prospective benefit?
• Who did the prospective benefit fall to?
• Was there any other way of conducting the research that involved less risk for participants?

Front 9

How to identify the level of risk entailed by research participation (or, in the case of research without consent, research contribution), 4 categories:

Back 9

(1) Research not involving greater than minimal risk
(2) Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
(3) Research offering a minor increase over minimal risk and holding out no prospect of direct benefit to the individual subjects, but likely to yield generalizable information concerning the individual’s condition
(4) Research (not included in the previous three categories) that presents an opportunity to understand, prevent or alleviate a serious problem affecting the [lives of the group from which the participants are from]’