HUMAN RESEARCH ETHICS

INTRODUCTION TO RESEARCH ETHICS: ISSUES, GUIDELINES, PRINCIPLES AND VALUES

PART B:

CASE STUDY TWO: A new diabetes drug

Patients with mild (Type 2) diabetes (defined as having a fasting plasma glucose of 7.0mmol/L to 7.8mmol/L) usually respond to a treatment regimen of diet, exercise and weight reduction. Some do require additional anti-diabetic treatment.

A pharmaceutical firm has developed a new protein derived drug, which stimulates a rapid release of insulin (of short duration) from pancreatic cells. In animal studies this drug, N17, appears to be safe, and it is now proposed to test its efficacy and tolerability in a Diabetes Type II population.

The drug will be supplied by the firm to the hospital pharmacy. Tablets will be three strengths: 25mg, 50mg and 100mg. A placebo which looks the same will also be supplied. Patients who attend Dr A in the Diabetes Clinic will, if they wish, participate in the trial and be randomised to one of four groups: group one will receive the 25mg strength, group two the 50mg strength, group three the 100mg strength and group four the placebo. The pharmacy will code the drug and document the patients in each group. Neither the patients nor the doctor will know to which group each patient has been assigned.

The patient will be asked to maintain any prior program of diet and exercise, and body weight and fasting plasma glucose will be measured and documented at various times in the 24 weeks of the trial. During this time the patient will take one of the assigned tablets 30 minutes before each meal.

The Research Plan toxicology data, Patient Information Sheet and Consent Form have been submitted to the Hospital Ethics Committees of several Australian hospitals, with the overall intention of enrolling 1000 patients in the trial.

QUESTIONS

  1. If you were asked to be a co-researcher or to review this study, what would concern you and what would you want to know before you agreed or approved it?

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

Matters that might concern participants or on which they would want information include:

  1. Is the trial being conducted in order to gain new knowledge or only to establish grounds for the registration and marketing of N17, the new drug?
  2. Will Dr A's patients feel coerced to agree to involvement because of their previous relationship with him as their doctor?
  3. Is the researcher's use of contacts a breach of their privacy or confidentiality? Can a professional doctor also be a researcher with the same people who are his patients?
  4. What information will be provided to inform their consent?
  5. What are the risks of any harm of the new drug and how will these be disclosed and explained to participants?
  6. How will the risks to participants be monitored?
  7. Will participants have to stop taking their current medication?
  8. Will participants know about being randomised to one of four groups and how will this be explained to them?
  9. What will happen if people receive only the placebo and their health suffers?
  10. How long will the trial last?
  11. Will participants have a right to receive the new drug after the trial if it proves to be better than current treatment?
  12. How will the research contribute to improvement of the treatment of diabetes?

This is not a complete list and you may have thought of other issues in addition. The purpose was to commence reflection on the kind of issues that are typically included in research ethics.

In clinical trials, as opposed to interview based research such as in Case Study One, issues of risks to participants tend to be dominant. This expresses one of the central commitments of research ethics: to protect the welfare of participants who, are, after all, volunteering themselves. However, issues of the consent process and of the benefit of the research remain important.




  1. Why do you think that the answers you have given to question A are ethical issues?

You are encouraged to write down your answers to this question in the box below but you don't have to. This is not a test but rather an opportunity to see whether the issues that you identify are the same, in substance, as those that are listed in the answer to the question on the next page.

Many of the matters listed as answers to question A involve relationships between the researcher and research participants or potential participants in which the interests and welfare of participants is at risk unless care is taken. Ethics generally is about the way people live and thus the way that they relate to others and the effects that those relationships can have on others. The key relationship in research ethics is that between the researchers and the participants and it nearly always involves ethical considerations because it is nearly always unequal, that is, researchers usually have relatively more influence or status than participants who are thus often at risk of feeling persuaded to make decisions, such as agreeing to participate, as a result of that influence. Hence, research ethics is attentive the impact of that relationship.

The 12th issue listed above is a matter of ethics because the involvement of other human beings in research as participants needs to be justified as worth while. If research is poorly designed so that it cannot generate results that have meaning or validity, the involvement of those participants is wasteful and disrespectful of their humanity. Although there is a close relationship between this issue and issues of science or research design, the distinction between ethics and science needs to be maintained.