Hints and tips

When assessing applications for approval, the HREC must ensure all elements of the protocol comply with ethical standards.

The HREC is responsible for ensuring that participants will not be harmed by participation in the research; that they understand the nature of the research and its possible consequences for them in terms of impact on their well-being; and that they freely agree to participate.

The HREC is also responsible for protecting the confidentiality and privacy of individuals by ensuring the security, storage and disposal of confidential data collected during the conduct of the research.

The NHMRC's National Statement on Ethical Conduct in Human Research (NS) details the following matters that should be considered by HRECs when assessing whether a particular research protocol is acceptable.

Your project

'Research is ethically acceptable only when its potential benefits justify any risks involved in the research. Benefits of research may include, for example, gains in knowledge, insight and understanding, improved social welfare and individual wellbeing, and gains in skill or expertise for individual researchers, teams or institutions.' (NS Section 2.1)

What the HREC will consider:

  • Is there a clear hypothesis?
  • Is the research question useful? Is the research worthwhile?
  • Is the research likely to yield new information, enhance understanding or clarify existing uncertainty?
  • Has this, or similar research been carried out before in the same or similar contexts?
  • Can the research proposal be supported by a systematic review of the literature that would demonstrate the importance of the research question and that it builds upon the results of previous research?
  • If indicated, have perspectives of potential participant groups, the wider community, or other disciplines been incorporated into the research proposal?
  • Does the value of the project appear to be adequate to justify its conduct with humans?

Researchers

'Research that has merit is conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research.' (NS Section 1.1)

What the HREC will consider:

  • Do the researchers have necessary qualifications, competence and experience?
  • Are there adequate arrangements to ensure that members of the research team are aware of relevant ethical and legal obligations?

Funding

'A researcher should disclose to the review body the amount and sources or potential sources of funding for the research.' (NS Section 5.2.7)

What the HREC will consider:

  • What is the relationship between the source of funding and the aims of the project?
  • Does that relationship have any implications for the ethical conduct of the project, especially the recruitment of participants, the character of information sought or the freedom to publish the results?
  • Include the funding source in the Plain Language Information Statement (PLIS) for participants.

Research methodology

'The design and conduct of each research protocol must reflect a) respect for human beings; b) research merit and integrity; c) justice; and d) beneficence.' (NS Section 1)

What the HREC will consider:

  • Are all aspects of the research methodology clearly described?
  • Is the methodology appropriate to the achievement of the aims of the project?
  • Provide an outline of the proposed method - include details of:
    • data collection techniques
    • tasks participants will be asked to do
    • the estimated time commitment involved
    • how data will be analysed
    • If the project includes any procedure that is already established and uses accepted techniques please include a description of the procedure

Recruitment of participants

'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' (N Section 1.11).

What the HREC will consider:

  • Is it clear how participants will be recruited?
  • Describe your proposed recruitment strategy to source target participants in full.
  • Do the recruitment methods respect participants' rights to the confidentiality of their affairs?
  • Are the proposed participants appropriate in number and kind?
  • Provide a justification of your proposed sample size. include details of statistical power of the sample where appropriate.
  • Ensure the requirements for consent are met. (NS: 2.2)

Consent

'Consent to participate in research must be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.' (NS Section 2.3)

What the HREC will consider:

  • Are the ways in which participants will be approached clearly described in the Consent form and the Plain Language Information Statement (PLIS)?
  • Is the information to be provided to potential participants adequate in content and appropriate in form?
  • Do the proposed methods of securing consent to participate provide
    • a) sufficient time to consider the decision;
    • b) evidence that participants understood their choices, and
    • c) sufficient opportunities to ask questions and re-consider?
  • Remember, the consent of a person to participate in research must not be subject to any coercion - whether perceived or real!
  • Researchers should choose participant cohorts where no dependent relationship exists.
  • if the researcher believes that research involving people in dependent relationships is purposeful and methodologically defensible, they must provide additional information explaining why this is so and how any risks inherent in the dependent and unequal relationship will be managed.
  • The HREC will also need evidence to show that participants have been reassured that refusal to participate will not result in any discrimination or penalty. Applicants should note that reasons of convenience will not normally be considered adequate

Burdens of research - risk & risk management

'Research is ethically acceptable only when its potential benefits justify any risks involved in the research.' (NS Section 2)

What the HREC will consider:

  • Are the burdens and risks of research to participants clearly identified and have appropriate measures been taken to minimise these?
  • Is the balance between the burdens and risks to participants and the aims and benefits of the project such as to warrant approval?
  • What will you do should an emergency occur, or a participant becomes distressed?
  • Identify as far as possible all potential risks to participants
  • Explain what risk management procedures will be put in place.
  • Any potential risks should be outlined in the Plain Language Information Statement (PLIS) along with contact details of an appropriately qualified organisation for participant reference in case of distress, eg: Lifeline

Incentives for participation

'Payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable.' (NS Section 2.2.10)

What the HREC will consider:

  • Are financial or other rewards proposed to be given to participants?
  • Are these of such a size or value that they may unduly influence the freedom of participants to withdraw or otherwise protect themselves from risks?

Discontinuing participation

'Participants are entitled to withdraw from the research at any stage. Before consenting to involvement in the research, participants should be informed about any consequences of such withdrawal.' (NS Section 2.2.20)

What the HREC will consider:

  • Are the ways in which participants are advised of their freedom to withdraw sufficient in content and frequency?
  • Participants are free to withdraw consent at any time during the study, whereby participation in the research study will immediately cease and information/data obtained from it will not be used.
  • The exception to this is if participant withdrawal occurs  after information has been aggregated - so, if applicable, advise participants in the PLIS, that from this point it is not possible to withdraw participant information/data, although consent to participate can still be withdrawn..

Information protection

.It is the duty of the custodian to ensure that the data are used responsibly and respectfully, and that the privacy of participants is safeguarded'. (NS 3.2.5)

What the HREC will consider:

  • Is it clear who will (and who will not) have access to information collected during the project?
  • Are the proposed storage and security measures adequate?
  • Are participants clearly informed that information they provide will be used only for the project?
  • What measures are proposed to protect the confidentiality of information in the course of the project and are these adequate to give the degree of protection promised to participants?
  • Are the manner and form in which results will be published clearly described, and do they adequately protect the confidentiality of information and privacy of participants?

Legal issues

Confidentiality of information provided can only be protected within the limitations of the law. Depending on the research proposal, you may need to state these limitations specifically (subpoena, freedom of information claim, mandated reporting by some professions, etc.)

What the HREC will consider:

  • Does the project involve subject matter or conduct which may give rise to legal vulnerability of participants or researchers?
  • Are adequate precautions to be taken?
  • Have you included appropriate information on the legal limitations of protecting confidentiality in the PLIS and consent form?

No research project involving human participants can proceed without official written approval from the HREC.