HUMAN RESEARCH ETHICS

MODULE FIVE: RESPECT

PART C:
Using the National Statement

For each of the selected issues from the case study, which aspect of the VALUE and PRINICPLE of respect and which GUIDELINE(S) would help you to answer the question?

In addition to chapters 1 (Values and Principles), 2.2 (General Requirements for Consent) and 2.3 (Qualifying or Waiving Conditions for Consent) it is likely that chapters 3.1 (Qualitative methods), 3.2 (Databanks), 4.3 (People in dependent or unequal relationships) and 4.5 (People with a cognitive impairment, an intellectual disability or a mental illness) will be relevant.

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

  1. What is the justification for not seeking and waiving the need for consent to the researcher's use of the survivors' records?

    A. Which is the relevant aspect of the Value and Principle of Respect?

    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.


    B. Which is or are the relevant guidelines?

    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:

    (a) involvement in the research carries no more than low risk (see paragraphs 2.1.6 and 2.1.7, page 18) to participants;
    (b) the benefits from the research justify any risks of harm associated with not seeking consent;
    (c) it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records);
    (d) there is no known or likely reason for thinking that participants would not have consented if they had been asked;
    (e) there is sufficient protection of their privacy;
    (f) there is an adequate plan to protect the confidentiality of data;
    (g) in case the results have significance for the participants' 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);
    (h) 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;
    (i) the waiver is not prohibited by State, federal, or international law.


  2. What is the justification of not disclosing to focus group attendees that the focus groups will be used for analysis and not only discussion?

    A. Which is the relevant aspect of the Value and Principle of Respect?

    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.


    B. Which is or are the relevant guidelines?

    2.3.1 Where limited disclosure does not involve active concealment or planned deception, ethical review bodies may approve research provided researchers can demonstrate that:

    (a) there are no suitable alternatives involving fuller disclosure by which the aims of the research can be achieved;
    (b) the potential benefits of the research are sufficient to justify both the limited disclosure to participants and any risk to the community's trust in research and researchers;
    (c) the research involves no more than low risk to participants (see paragraph 2.1.6, page 18), and the limited disclosure is unlikely to affect participants adversely;
    (d) the precise extent of the limited disclosure is defined;
    (e) whenever possible and appropriate, after their participation has ended, participants will be:
    (i) provided with information about the aims of the research and an explanation of why the omission or alteration was necessary; and
    (ii) offered the opportunity to withdraw any data or tissue provided by them.

    2.3.2 Where limited disclosure involves active concealment or explicit deception, and the research does not aim to expose illegal activity, researchers should in addition demonstrate that:

    (a) participants will not be exposed to an increased risk of harm as a result of the concealment or deception;
    (b) a full explanation, both of the real aims and/or methods of the research, and also of why the concealment or deception was necessary, will subsequently be made available to participants; and
    (c) there is no known or likely reason for thinking that participants would not have consented if they had been fully aware of what the research involved.


  3. Will any of the information provided for consent to the interviews amount to unethical coercion or pressure?

    A. Which is the relevant aspect of the Value and Principle of Respect?

    1.13 Where participants are unable to make their own decisions or have diminished capacity to do so, respect for them involves empowering them where possible and providing for their protection as necessary.


    B. Which is or are the relevant guidelines?

    2.2.9 No person should be subject to coercion or pressure in deciding whether to participate. Even where there is no overt coercion or pressure, consent might reflect deference to the researcher's perceived position of power, or to someone else's wishes. Here as always, a person should be included as a participant only if his or her consent is voluntary.

    2.2.19 People who elect not to participate in a research project need not give any reason for their decision. Researchers should do what they can to see that people who decline to participate will suffer no disadvantage as a result of their decision.

    3.1.15 Researchers should consider whether respect for the participants requires that the accuracy or completeness of each interview transcript should be verified by the relevant participant before analysis is complete.

    3.1.16 The method of providing consent in qualitative research depends on various factors, including the type of research, its level of sensitivity, its cultural context, and the potential vulnerability of the participants. In some contexts, the protection of vulnerable participants may favour a formal, written process of consent; in other contexts, an oral process.

    4.3.8 The design of research involving those in dependent relationships should not compromise respect for them.

    4.5.9 Researchers should inform HRECs how they propose to determine the capacity of a person with a cognitive impairment, an intellectual disability, or a mental illness to consent to the research. This information should include:

    (a) how the decision about the person's capacity will be made;
    (b) who will make that decision;
    (c) the criteria that will be used in making the decision; and
    (d) the process for reviewing, during the research, the participant's capacity to consent and to participate in the research.


  4. Is the request for use of non-identified data for future research an ethically justifiable use of unspecified consent?

    A. Which is the relevant aspect of the Value and Principle of Respect?

    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.


    B. Which is or are the relevant guidelines?

    2.2.14 Consent may be:

    (a) 'specific': limited to the specific project under consideration;
    (b) 'extended': given for the use of data or tissue in future research projects that are:
    (i) an extension of, or closely related to, the original project; or (ii) in the same general area of research (for example, genealogical, ethnographical, epidemiological, or chronic illness research);
    (c) 'unspecified': given for the use of data or tissue in any future research.
    The necessarily limited information and understanding about research for which extended or unspecified consent is given can still be sufficient and adequate for the purpose of consent (see paragraph 2.2.2).

    2.2.15 Extended or unspecified consent may sometimes need to include permission to enter the original data or tissue into a databank or tissuebank (see paragraph 3.2.9, page 31).

    2.2.16 When unspecified consent is sought, its terms and wide-ranging implications should be clearly explained to potential participants. When such consent is given, its terms should be clearly recorded.

    3.2.9 When collecting data for deposit in a databank, researchers should provide clear and comprehensive information about:

    (a) the form in which the data will be stored (identifiable, re-identifiable, non-identifiable);
    (b) the purposes for which the data will be used and/or disclosed; and
    (c) whether they will seek:
    (i) specific, extended or unspecified consent for future research (see paragraphs 2.2.14 to 2.2.16, page 21); or
    (ii) permission from a review body to waive the need for consent (see paragraphs 2.3.5 and 2.3.6, page 24).

  5. Will the offer of payment of $500.00 for interviews encourage participants to expose themselves to risks they might otherwise have avoided?

    A. Which is the relevant aspect of the Value and Principle of Respect?

    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.


    B. Which is or are the relevant guidelines?

    2.2.10 It is generally appropriate to reimburse the costs to participants of taking part in research, including costs such as travel, accommodation and parking. Sometimes participants may also be paid for time involved. However, payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable.

    2.2.11 Decisions about payment or reimbursement in kind, whether to participants or their community, should take into account the customs and practices of the community in which the research is to be conducted.