Do I have to participate?
No! Participating in a research study is voluntary. Whether or not you take part is your choice. If you don’t want to take part, you don’t have to give a reason, and it won’t affect the care you receive. If you do want to take part now, but change your mind later, you can pull out of the study at any time.
What is informed consent?
Informed consent is an interactive process between a researcher and a study participant where the participant gains an understanding of what the study involves and receives an explanation of the implications of their involvement in the research. These implications may include the expected risks, side effects, benefits and costs of participating. Through gaining a full explanation of the implications, the potential participant is therefore able to make an informed choice and give their informed consent.
Most research studies using human participants needs to gain ethical approval from a ethics committee before it can begin. The three main ethics committees that BAIL researcher apply to are:
- CDHB Research Committee
- University of Otago Human Ethics Committee
- The Health and Disability Ethics Committee (HDEC) – administered by the Ministry of Health
The committee that is applied to depends on where the research is taking place (e.g. within the hospital or with participants who are living in the community) and the expected degree of risk to participants (e.g., a clinical trial of a new treatment procedure is considered higher risk than a qualitative study in which people share their experiences of their illness or injury).
The advertisement and information sheet for the research study should always include evidence of approval from an ethics committee.
Your rights – what to do if there is a problem?
The information sheet should include information on who to contact to talk through any concerns or questions you may have. There are usually four main options:
- The researcher and/or their supervisor or the principal investigator
- The ethics committee who approved the study
- A Health and Disability Advocate at the Health Advocates Trust
- Cultural Advisor
Should I participate? How do I balance the benefits and risks?
It is important that you understand what risks are anticipated in the study you are considering and that you weigh the risks and benefits of participating in research. When thinking about risk, consider these important questions:
- What is the chance that the study will cause me harm?
- If there is a chance of harm, how much harm could I experience?
- Are the benefits of taking part in the study more important to me than the risks?
If you are considering joining a study, ask the researchers any questions that will help you decide whether to participate. This includes asking for more information about parts of the conversation or written materials. Taking time to share your concerns will help you feel safe if you do decide to volunteer. It may be helpful to involve close family members, your doctors, or friends in this decision-making process. Remember that joining a research study is voluntary and that even after joining, if you change your mind, you can stop taking part at any time. The research staff will help you do this safely.
Regardless of whether you decide to take part in the study or not, it is important to make a decision that is right for you.
Questions to ask before you agree to participate
The questions below are useful for participants, potential study volunteers, and their family members or friends, to ask the research staff – which can include doctors, nurses, study coordinators and other people who help conduct the study. Not all of the questions will be relevant for every study.
- What is the main purpose of this study? What is being studied?
- Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
- How will the treatment be given to me? What tests and procedures are involved?
- What will I have to do as part of the study?
- Will I, and if so how often will I, have to visit the hospital or clinic?
- How will it be determined which interventions I receive (for example, by chance)?
- Who will know which intervention I receive during the study? Will I know? Will members of the research team know?
- How long is the study going to last and what will I be asked to do as a participant?
- How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
- What has been learned about the study treatment and are any study results published?
- Do I have to pay for any part of the study?
- Is there any reimbursement for costs – e.g., travel costs or childcare?
- Will I be able to see my own doctor?
- If the treatment works for me, can I keep using it or accessing it after the study?
- Can anyone find out whether I’m participating in the study?
- Will I receive any follow-up care after the study has ended?
- What will happen to my medical care if I stop participating in the study?
- Does the physician/investigator have any financial or special interest in the study?
- What are the credentials and research experience of the researcher or other study staff?
- Will results of the study be provided to me?
- What are my options if I am injured during the study?
Who will see my information?
The information that is provided during the study should remain strictly confidential. The researcher should be the only person that sees the information. If this is not the case, then any other person accessing your information should be named on the information sheet.
No material that could personally identify you should be used in any reports from the study. This includes your name, but also other identifying information such as a specific diagnosis, place of work or other such unique identifying features.
The research information sheet should tell you where and how the information collected during the study will be stored both during the study, but also after it has finished.
How can I find out how to participate?
You can offer to participate in any research studies that are currently being profiled by BAIL.
Alternatively you may from time to time be contacted directly to ask if you would be interested in finding out more about a specific study that is taking place. This contact may occur because in the past you have taken part in a research project, or because you have agreed to have someone contact you. For example, you may have agreed to have information about your hip surgery kept on a database, and as part of this you agreed to be contacted in the future if research using this data was being used). You ALWAYS have the right to decline to participate in any research, regardless of you agreeing to be contacted in the past.
Will being involved in the research effect my usual healthcare?
Agreeing to participate in research should not impact on your ability to access your usual healthcare.
While, in some situations, the study may be offered by the staff involved in your care, you should always be able to decline participating in the research component without in any way affecting your usual healthcare.
Who funds the research?
Funding for the research may be gained from a variety of sources. For example, funding may have been obtained from one, or a number, of the following sources:
- University funding sources
- Health Research Council
- Charities and community groups (e.g., Rotary NZ, Rata Foundation, Lotteries Commission)
- Professional bodies (e.g., Physiotherapy New Zealand)
- Alternatively, some studies are self –funded. In this case they may be carried out by clinicians or students (Masters or Ph.D. candidates) without financial support
- You have the right to request information about how the study is funded
Māori consultation process
Within New Zealand there is a requirement to consult with Māori in the design of all health research due to a commitment to partnership with Māori consistent with the Treaty of Waitangi.
Māori Consultation within the CDHB occurs via Te Komiti Whakarite
Within the University of Otago, the Policy for Research Consultation with Māori provides the framework for an appropriate and mandated consultation process with Māori for research. It ensures an effective and efficient mechanism for managing the consultation process while acknowledging the needs and aspirations of Ngāi Tahu for Māori development.
End-user consultation process
Within the Burwood Academy for Independent Living (BAIL) there is the opportunity for researchers to consult with the Burwood Academy Consultation (BAC) Group. This is an initiative to promote consultation between researchers and their populations of interest.
BAC is based on the philosophy that people with lived experience should have a stake in the research process. The group aims to encourage productive dialogue between researchers and their populations of interest. Having projects reviewed by people with the lived experience of disability has the potential to provide people with the lived experience of disability a greater stake in the research process, as well as improve the overall integrity and quality of the research.