Risk and review

The overarching principle of ethical human research is the protection of human participants.

Review of human research is conducted to ensure that the welfare of participants is considered and attended to by researchers. The guiding ethical principles of the University of Waikato’s Ethical Conduct in Human Research and Related Activities Regulations align with the Health Research Council’s Research Ethics Guidelines (2017) guiding principles for research involving human participants.

This includes

• Informed consent
• Value of the research and related activities
• Risks and potential benefits
• Payments for participating in research
• Protection of privacy and confidentiality
• Cultural responsiveness

In addition, the following principles are acknowledged as important and are considered in the review of research

• Selection and recruitment
• Respect for property rights
• Adherence to professional codes of ethics

Through the review process, an assessment of risk is made. Risk can be defined as “a potential for harm, discomfort or inconvenience. It involves

1. The likelihood that a harm (or discomfort or inconvenience) will occur
2. The severity of the harm, including its consequences (National Health and Medical Research Council, Australia, 2007[2015]).
3. Risk is compounded in research when there are many potential harms, even when the consequence of each type of harm is, on its own, minimal

Minimally, research can involve physical or psychological discomforts. Such discomforts are identified as being within the range of day-to-day experiences of healthy individuals.

Discomforts can include

• Physical discomfort related to measuring blood pressure
• Unease induced by an interview,
• The inconvenience of filling in a form
• The unpleasantness or discomfort associated with tasting food, non-alcoholic beverages, or over-the-counter nutritional supplements
• Fatigue induced by a period of concentration
• Discomfort associated with viewing unpleasant images
• Discomfort associated with being in a virtual reality environment
• Discomfort associated with low-intensity exercise

Harm in research can affect participants and/or others and includes

• Physical harms, including injury, illness, pain
• Psychological harms, including feelings of worthlessness, distress, guilt, anger or fear related, for example, to disclosure of sensitive or embarrassing information, or learning about a genetic possibility of developing an untreatable disease
• Devaluation of personal worth, including being humiliated, manipulated or in other ways treated disrespectfully or unjustly
• Social harms, including 
  • Damage to social networks or relationships with others
  • Discrimination in access to benefits
  • Service, employment or insurance
  • Social stigmatization
  • Findings of previously unknown paternity status
• Economic harms, including the imposition of direct or indirect costs on participants
• Legal harms, including discovery and prosecution of criminal conduct
• Cultural harms, including insult to participants and their communities, through the disrespect of indigenous language, knowledge systems, spiritual traditions, histories and philosophies, cultural practices, and aspirations. As well as threats to indigenous rights to land, territories, resources, and self-determination

(Australian National Statement on Ethical Conduct in Human Research (2007 [2015], United Nations Declaration on the rights of Indigenous people (2008)).

The inclusion of ‘vulnerable participants’ increases the risk level of research.

Vulnerability “describes people who have a restricted capability to make independent decisions about their participation in the study... [and] also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either because of their health status, physical or mental capacity or employment status, or as a result of imprisonment” (HRC Ethical Guidelines for Intervention Studies, July 2012, p. 14).

The HRC Ethical Guidelines for Observational Studies (July 2012, revised edition), HRCEthical Guidelines for Intervention Studies (July 2012, revised edition), and the Australian National Statement on Ethical Conduct in Human Research (2007[2015]) identify the following examples of groups of participants who are potentially vulnerable

• Children (under 14 years) and young people (14 to 17 years)
• People with mental illness
• People with serious intellectual disability
• People whose freedom to make independent choices is restricted or who are in a dependent or unequal relationship (e.g. prisoners, employees or students of a researcher or sponsoring company)
• People who may have difficulty comprehending the research
• People who may be involved in illegal activities

The sensitivity of a topic affects the risk level of research. Sensitivity may be context-dependent but some topics are always sensitive.

Sensitive topics can include

• Sexual behaviors and orientation
• Fertility, pregnancy, and parenting
• Illegal behaviors
• Religion
• Politics
• Death and dying
• Severe or chronic illness
• Mental health (e.g., addiction, depression, anxiety, eating disorders, body image)

The nature of research reporting affects the level of risk in research. There are a number of concerns in this area, including most importantly, the intentions of the researcher to report participant identities in research outputs, including in oral presentations, and formal publications in a variety of media.

A participant may be identifiable in research for the following reasons

• A participant is named
• A participant’s iwi or hapu is identified
• A selection of a participant’s identifying details is presented
• A still/moving image of the participant or their identifiable personal belongings is presented
• A participant’s role within an organisation is identified
• A participant’s employer, organisation, or community association is identified
• A participant’s social network is identified

Ethical Conduct in Human Research and Related Activities Regulations. (2008 – under review). University of Waikato.

HRC Research Ethics Guidelines (December 2017). Health Research Council of New Zealand. Te Kauniheri Rangahau Hauora o Aotearoa.

Australian National Statement on Ethical Conduct in Human Research. 2007 (Updated May 2015). National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors’ Committee.

United Nations Declaration on the rights of Indigenous people. 2008. United Nations.