Guidelines: Patient recruitment

Ethical considerations with patient recruitment

When recruiting patients, there are a number of aspects that researchers should take into account. Outlined below are a few key considerations.

Please ensure that you have read the information on where to obtain approval for recruitment in NSW Health facilities.

When patients attend private hospitals or clinics they are often unwell, and as such are a vulnerable participant group. Researchers need to design their studies to take into account how informed consent will be obtained in a respectful manner. Patients should be afforded time to consider participation in the research and the implications for them and their medical treatment. Respect for patients extends to their privacy and should be considered when recruitment is undertaken in clinic waiting rooms.

Where a researcher is also the treating health professional, the implications of this dependent/ unequal relationship should be considered and managed appropriately.

“Where the researcher is also the treating health professional, it should be considered whether an independent person should seek the consent of potential participants”. (NS 3.3.17)

To avoid real or potential coercion, consideration should be given to having participants approached by a third person not connected with the research, or advertising the study in clinics by means of a flyer.

Researchers should also consider potential conflicts of interest and how they will be managed. Any direct financial benefit to researchers or clinicians involved in the research must be disclosed to patients. Examples where conflicts of interest may occur include:

  • Clinicians receiving payment for patients recruited
  • Researchers with shares in a company developing a study drug or receiving payment for the study
  • Researchers or clinicians developing a commercial medical device.

The National Statement outlines that a guiding principle for researchers is “that a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.” (NS 2.2.1).

Researchers need to consider how information can best be conveyed in the patient setting. There should be no negative consequences for patients who elect not to take part in a research study and it should be made clear that patients have the right to decline any participation without comprising their subsequent treatment.

Specific ethical concerns are raised when research involves patients highly dependent on medical care who may be unable to give consent. Examples of these situations include: neonatal intensive care; terminal care; emergency care; intensive care; and care of unconscious people. Researchers should refer to guidance in chapter 4.4 of the National Statement.

Use of medical records in research

As health information is a particularly sensitive type of information, its use in research is subject to special ethical and legislative protections. Please see our guideline on the use of existing datasets in research for more information on how to comply with these requirements when conducting a research project that involves existing medical records.