HUMAN RESEARCH ETHICS

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

PART C:

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

For each of the four selected issues from this case study, which VALUE, which PRINICPLE and which GUIDELINE(S) would help you to answer the question? To assist you, in addition to chapters 1 (Principles) 2.1 (Risk) and 2.2 (Consent), it is likely that chapters 3.4 (Human tissues samples), 3.5 (Human genetics) and 4.3 (People in dependant relationships) will be relevant.

You are encouraged to make some choices of your own in the free text box provided before clicking the VALUE, PRINCIPLES AND GUIDELINE(S) buttons after each question to take you to the suggested answers.

[Revise Case Study]

QUESTIONS

1. How will the clinics and families be identified?

  1. Which is the relevant VALUE?

At a profound level, justice involves a regard for the human sameness that each person shares with every other. Human beings have a deep need to be treated in accordance with such justice, which includes distributive justice and procedural justice. In the research context, distributive justice will be expressed in the fair distribution of the benefits and burdens of research, and procedural justice in Ôfair treatmentÕ in the recruitment of participants and the review of research. While benefit to humankind is an important result of research, it also matters that benefits of research are achieved through just means, are distributed fairly, and involve no unjust burdens. (NS p. 11)



  1. Which is the relevant PRINCIPLE?

1.4 In research that is just:

  1. taking into account the scope and objectives of the proposed research, the selection, exclusion and inclusion of categories of research participants is fair, and is accurately described in the results of the research;
  2. the process of recruiting participants is fair;
  3. there is no unfair burden of participation in research on particular groups;
  4. there is fair distribution of the benefits of participation in research;
  5. there is no exploitation of participants in the conduct of research; and
  6. there is fair access to the benefits of research. (NS p.12)



  1. Which is or are the relevant GUIDELINE(S)

3.5.4 Researchers should consider the potential psychological, social and cultural significance of their research. Where complex socially significant characteristics or the genetic characteristics of communities are being investigated, there is a risk that the research may be misrepresented or misused in ways that lead to prejudice, disrespect or other harm to participants or communities. In designing, conducting and reporting research of this nature, researchers should consider how to counter the possibility of such harm. (NS p. 43)




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?

  1. Which is the relevant VALUE?

Among these values, respect is central. It involves recognising that each human being has value in himself or herself, and that this value must inform all interaction between people. Such respect includes recognising the value of human autonomy Ð the capacity to determine oneÕs own life and make oneÕs own decisions. But respect goes further than this. It also involves providing for the protection of those with diminished or no autonomy, as well as empowering them where possible and protecting and helping people wherever it would be wrong not to do so. (NS. p.11)



  1. Which is the relevant PRINCIPLE?

1.10 Respect for human beings is a recognition of their intrinsic value. In human research, this recognition includes abiding by the values of research merit and integrity, justice and beneficence. Respect also requires having due regard for the welfare, beliefs, perceptions, customs and cultural heritage, both individual and collective, of those involved in research.

1.11 Researchers and their institutions should respect the privacy, confidentiality and cultural sensitivities of the participants and, where relevant, of their communities. Any specific agreements made with the participants or the community should be fulfilled.

1.12 Respect for human beings involves giving due scope, throughout the research process, to the capacity of human beings to make their own decisions.



  1. Which is or are the relevant GUIDELINE(s)?

2.3.6 Before deciding to waive the requirement for consent (other than in the case of research aiming to expose illegal activity), an HREC or other review body must be satisfied that:

  1. involvement in the research carries no more than low risk (see paragraphs 2.1.6 and 2.1.7, page 18) to participants;
  2. the benefits from the research justify any risks of harm associated with not seeking consent;
  3. it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records);
  4. there is no known or likely reason for thinking that participants would not have consented if they had been asked;
  5. there is sufficient protection of their privacy;
  6. there is an adequate plan to protect the confidentiality of data;
  7. in case the results have significance for the participantsÕ welfare there is, where practicable, a plan for making information arising from the research available to them (for example, via a disease-specific website or regional news media);
  8. the possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled;
  9. the waiver is not prohibited by State, federal, or international law.




9. Will the identity of participants be concealed in the publication of results of the project and if so how?

  1. Which is the relevant VALUE?

Researchers exercise beneficence in several ways: in assessing and taking account of the risks of harm and the potential benefits of research to participants and to the wider community; in being sensitive to the welfare and interests of people involved in their research; and in reflecting on the social and cultural implications of their work. (NS p.11)



  1. Which is the relevant PRINCIPLE?

1.6 The likely benefit of the research must justify any risks of harm or discomfort to participants. The likely benefit may be to the participants, to the wider community, or to both.

1.7 Researchers are responsible for:

  1. designing the research to minimise the risks of harm or discomfort to participants;
  2. clarifying for participants the potential benefits and risks of the research; and
  3. the welfare of the participants in the research context.

1.8 Where there are no likely benefits to participants, the risk to participants should be lower than would be ethically acceptable where there are such likely benefits. (NS p.13)



  1. Which is or are the relevant GUIDELINE(s)?

3.5.13 Researchers must ensure the confidentiality and privacy of stored genetic information or research results relating to identified or re-identifiable participants. Such information or research results should be disclosed to treating clinicians only in accordance with the consent given for the research.

3.5.14 The rarity of some genetic disorders might allow certain families or individuals to be identified by other researchers, and in some cases by members of the community, even if information is given to others in non-identifiable form. For this reason, where genetic data are stored, confidentiality might sometimes require restrictions on the release of data for research use (see paragraph 3.2.8, page 31). (NS. p.45)




10. How will the research contribute to improvement of the diagnosis and treatment of breast cancer?

  1. Which is the relevant VALUE?

Research merit and integrity are discussed first. Unless proposed research has merit, and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable. (NS. p.11)



  1. Which is the relevant PRINCIPLE?

1.1 Research that has merit is:

  1. justifiable by its potential benefit, which may include its contribution to knowledge and understanding, to improved social welfare and individual wellbeing, and to the skill and expertise of researchers. What constitutes potential benefit and whether it justifies research may sometimes require consultation with the relevant communities;
  2. designed or developed using methods appropriate for achieving the aims of the proposal;
  3. based on a thorough study of the current literature, as well as previous studies. This does not exclude the possibility of novel research for which there is little or no literature available, or research requiring a quick response to an unforeseen situation;
  4. designed to ensure that respect for the participants is not compromised by the aims of the research, by the way it is carried out, or by the results;
  5. conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research; and
  6. conducted using facilities and resources appropriate for the research. (NS p. 12)



  1. Which is or are the relevant GUIDELINE(s)?

3.5.1 Where research may discover or generate information of potential importance to the future health of participants, or their blood relatives, researchers must prepare and follow an ethically defensible plan to disclose or withhold that information.

3.5.2 This plan must take into account the clinical relevance of the research information, the types of genetic test used in the research, and the results of those tests. In addition:

  1. The plan should:
    1. enable participants to decide whether they wish to receive the information and who else may be given the information;
    2. set out a process for finding out whether those other people want to receive information;
    3. include procedures to inform participants that the information would remain potentially identifiable;
    4. include measures to protect the degree of confidentiality that participants wish to maintain.
  2. When participants or their relatives are to be given or notified of genetic information that may be important for their health, the plan should either provide access to genetic and clinical advice and counselling, or clearly recommend to participants that they seek these services. Such advice and counselling should be provided by professionals with appropriate training, qualifications and experience.
  3. Where participants or relatives prefer not to receive genetic information that is important for their health, they should be advised that they will be approached to confirm this decision when the results of the research are available.
  4. Where the potential relevance of genetic information to participantsÕ health is not clear until after interim analysis of the research information, participants should again be given:
    1. the option of being notified of the existence of that information;
    2. the option of receiving the information; and/or
    3. access to, or a recommendation to seek, advice or counselling about the implications of these decisions.

3.5.3 Advice about the results of genetic research needs to include a clear explanation of the difference between research and clinical testing, and to clarify any need for clinical testing of research results.