HUMAN RESEARCH ETHICS

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

PART B:

CASE STUDY THREE: The relationship of Genetics and Lifestyle and Breast Cancer

It has been shown recently that mutations in two genes, BRCA1 and BRCA2, can create susceptibility to breast and ovarian cancer.

The research project aims to define the frequency of BRCA1 and BRCA2 mutations in Australians with familial breast and/or ovarian cancer, to define the variety of mutations present, to correlate each type of mutation with the risk of developing cancer and to try to identify environmental/lifestyle factors which influence risk.

In order to do this it is proposed to collect pedigrees, clinical information, DNA and tissue samples from families with familial breast cancer who have received treatment at cancer clinics around Australia and to transfer these research resources to a central repository.

The collected and stored DNA samples will then screened for mutations in the BRCA1 and BRCA2 breast cancer susceptibility genes and the variety of mutations and their frequency of occurrence will be calculated. Using data supplied with samples, from the pedigrees and clinical information, the correlation between the mutations and risks of developing cancer will be assessed.

Following these stages, the outcomes of the research will be published at conferences and in peer reviewed journals. It is proposed to store the pedigrees, clinical information, DNA and tissue samples as a national and international resource for future research by the proponents and other researchers.

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. How will the clinics and families be identified?
  2. Will the use of contacts involve a breach of their privacy or confidentiality?
  3. Will doctors who have treated patients with breast cancer be involved in recruiting participants?
  4. Will patients feel coerced to agree to involvement because of their previous relationship with their doctor?
  5. Will families be approached for their consent to the use of their samples and information or will researchers seek to waive the need for consent?
  6. What arrangements will be made to protect the privacy and confidentiality of the participants' information?
  7. Will they be told all what will happen to the samples and information, e.g where they will be stored, who will have access to them, will they remain identified, will they be destroyed at the end of the project?
  8. How long will the project last?
  9. Will the identity of participants be concealed in the publication of results of the project and if so how?
  10. How will the research contribute to improvement of the diagnosis and treatment of breast cancer?

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 population health studies, as opposed to interview based research or clinical trials, such as in Problems One and Two, methods of recruitment and the adequacy of information about how privacy and confidentiality will be protected are usually dominant. These become the risks to participation, rather than distress, as in Case Study One, or physical harm, as in Case Study Two. This is another expression of the central commitment of research ethics to protect the welfare of participants who, are, after all, volunteering their information and their tissue samples. 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 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.

Many of the matters listed as answers to question 1 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. Here, that relationship is not immediate, as in the first two case studies, but at a distance. Nonetheless, the relationship and the obligations that researchers have in that relationship to the providers of information and samples is of central importance to research ethics. 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.

Because participants volunteer for research and are not expected or required to do so, and because it is the nature of research that explores something unknown, it will almost always involve risks. A central focus of research ethics is about the protection of participants: how is the research project designed so as to minimise the risks that are involved?

The 10th 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.