Terminally ill participants – guidance

Study participants with a terminal illness are a vulnerable population. They require additional protection from coercion and undue influence.

However, it is important not to be too protective of competent participants simply because they have a terminal illness. Some participants with a terminal illness may find participation in a study a satisfying way of using their own misfortune to impart some good to others.

Important factors of terminal illness

Studies involving participants with a terminal illness must recognise these important factors:

  • Severe illness often affects a person’s competence.
  • Some people with a terminal illness may believe that they need to participate in a study in order to receive continuing care from health professionals.
  • Some people with a terminal illness believe that any treatment is preferable to none.

Information to provide

The study investigator must provide all participants with accurate and clear information about:

  • their eligibility for participation (diagnosis and prognosis)
  • treatment options (and whether or not participation in the study is a condition for receiving treatment)
  • risks and benefits
  • any costs to the participant.

The information provided should not raise false hopes or eliminate all hope. It should be provided well before the participant makes a decision about participating in the study.

Participants should be encouraged to consult with others, such as family members, close friends or medical consultants before deciding to participate.

Risks

  • Some risks may be justified by anticipated benefits for the study participants.
  • Some risks are associated with procedures performed purely for study purposes.

Costs

Any payment should not constitute an undue inducement, particularly if the participant population is economically disadvantaged.

General considerations

Special procedures in place: Studies that involve participants with a terminal illness should consider having special procedures in place to protect the rights and wellbeing of those participants.

Clinical investigator: The clinical investigator should be someone other than the participant’s physician.

Emergency services: Emergency services should be readily available.

Monitoring: The study’s progress should be monitored frequently. Factors to be monitored include:

  • anticipated toxicity of the therapeutic interventions
  • the extent to which participants are likely to be debilitated by either illness or therapy
  • the participant’s remaining life expectancy
  • whether participation in the study would require a change in residence (for example, from home or hospice to a hospital or research institution).

Other  considerations: The investigator should also consider the following questions:

  • Does the study need to involve participants with a terminal illness to achieve its objectives?
  • Have participants received clear information on how participation may affect their lifestyle?
  • Have participants been assured that they can withdraw from the study at any time?
    • If withdrawal from the study will lead to a participant being discharged from a research unit or end the participant’s access to health care that has been provided in conjunction with the study, is that fully explained?
  • Should a witness or health and disability consumer advocate be present during consent negotiations?
  • If a drug is administered at the community level, does the participant’s physician have access to information about the drug’s potential usefulness and risks?

For more information

For more information, refer to the NEAC Guidelines for Intervention Studies: Appendix 2.