There are national systems for gaining permissions to conduct research, and both the NHS and local government have research governance systems. These decide whether research is ethical or if it is of value to the sector. They study research projects carefully and look for potential risks to people who take part in them.
They require researchers to ensure that clear information is provided for those taking part in research. They also require all researchers to obtain informed consent from research participants, when they have the capacity to give it and have strict processes for what must happen for someone to participate in research who cannot give informed consent.
No research can occur in the NHS or through local authority social care services without approval from an ethics or research governance body.
Residents of care homes in England and Wales are also protected by the Mental Capacity Act (MCA) 2005 if they are unable to make decisions, for example, if they have severe dementia or brain injury. This sets out how an individual’s capacity to understand and give consent must be decided.
It requires those with care responsibilities to always act in the individual’s best interests if they lack the capacity to make the decision to take part in the research. It also requires that the researchers seek advice from people who know the resident well – ‘consultees’, who know what the residents wishes would be if they had capacity. Even if they lack capacity, residents should also be involved in this process, and researchers should always seek assent from the resident, this can be given verbally. An overview of the Mental Capacity Act can be found at Social Care Institute for Excellence 'At a glance' resources. Remember that those involved in a study can withdraw at any time.
It is also important that the owner / head office (where applicable) of the care home be made aware of the research and they should also agree to the home’s participation in the study.
WHAT TO EXPECT FROM RESEARCHERS
Residents, their family and friends, and care home staff should expect researchers to:
- Build a good relationship with the manager and staff, and get to know the home.
- Discuss compensation for time and provision of training.
- Ensure that someone explains the study to all the staff as well as the manager.
- Allow plenty of time for questions to be asked about the study before any research starts.
- Make sure the researchers give enough information to staff and residents without bombarding them.
- Ensure that material for residents takes account of possible problems with sight or hearing. Further information can be found in the Research with deaf people methods review and the Adult social care services for visually impaired people review.
- Provide a simple leaflet on who the researchers are, where they are from and what they will be doing.
- Be honest with the manager and staff at the beginning about the amount of time, resource and involvement required.
- Be respectful of people’s time.
- Highlight the benefits but also the expectations of being involved.
- Provide care homes with incentives to join the study. Not money necessarily (although this helps), but knowledge, feedback, skills and/or resources.
- Discuss and agree anonymity and confidentiality.
- Discuss the process of obtaining consent from participants or seeking the views of attorneys/ personal consultees/personal nominees.
- Discuss in advance what would happen in the event that a member of the research team had concerns about a resident’s care.
- Make all the GPs who have patients in this home aware of the study if appropriate.
- Behave ethically at all times. Unethical behaviour should be reported to the lead researcher and / or appropriate regulatory body or appropriate agency.
CONCERNS ABOUT QUALITY OF RESEARCH / RESEARCHERS
Care home staff should not tolerate disrespectful, unsatisfactory or unethical behavior by researchers e.g. being rude to a resident or failing to provide sufficient information. If they witness it or have concerns they should inform the research leader, or the research sponsor, as soon as possible
See also advice in "Getting involved in research".