Risk: Research trial pitfalls

Potential legal difficulties involving medical trials can range from participant complaints to more serious allegations of fraud. Ensure that you're research ready

 

MEDICAL research and drug trials are an essential part of healthcare development. In its guidance Good practice in research and Consent to research, the GMC states: “Research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and improving the health of the population as a whole”. However, involvement in research trials should not be undertaken lightly, and the responsibilities which go along with such trials should be met with appropriate rigour.

MDDUS receives a significant number of calls from members in regard to problems associated with research trials. These can range from participant complaints to more serious allegations of fraud. Complaints often arise around issues of communication and include concerns about the lack of clear information and inappropriate disclosures to others. Allegations can also centre on the skills or actions of those directly involved, particularly if the research involves taking physical measurements or carrying out minor procedures.

At the more serious end of the spectrum, allegations and complaints may be made to the regulators. The GMC usually regards proven research fraud as a significant departure from good practice, and a finding of impaired fitness to practise can be expected in order to maintain public confidence. Suspension or erasure will be likely outcomes for serious and/or repeated departures from good practice guidelines.

The safety and dignity of patients is always paramount and GMC guidance (Good Medical Practice) regarding honesty must underpin any research activity: "You must act with honesty and integrity when designing, organising or carrying out research, and follow national research governance guidelines and our guidance".

PREPARATION

Adequate preparation is key when embarking on a research project. In addition to ensuring that you have fully understood all the relevant documentation, the following areas merit consideration:

Is the trial useful/interesting? This may seem an odd question but if a trial is to run over some time and requires significant effort, there needs to be adequate continuing motivation. Unfortunately, we have seen cases where doctors have become bored or overwhelmed, and in order to progress the research they have cut corners. This can amount to fraud, with serious consequences.

Is the research based on a sound protocol? GMC research guidance states: "You must make sure that research is based on a properly developed protocol that has been approved by a research ethics committee. It must be prepared according to good practice guidance given by government and other research and professional bodies... Guidance on whether research requires ethical review under either the law or the policy of the UK health departments can be found on the National Research Ethics Service website."

Do you have adequate time and resources, and the requisite level of expertise to carry out the research? These considerations also apply to anyone delegated tasks.

Do the patients fully understand what is involved? Central to all the cases reported to MDDUS is the issue of communication, both amongst clinicians and particularly with the patients involved. In many cases, great reliance is placed on the patient information sheet and consent is obtained after the patient has reviewed and understood it. This is an important part of the process but does not remove the need to ensure that patients fully understand what the research entails and any associated risks. This requires direct discussion and the opportunity for any participant to raise questions.

Do the patients understand who will be made aware of their involvement in research to avoid allegations of breach of confidentiality? The GMC states in its research guidance: "With the participant’s consent, you should usually inform their GP and other clinicians responsible for their care about their involvement in a research project, and you should provide the doctors with any other information necessary for the participant’s continuing care. You should follow this advice regardless of whether the participant is a patient or a healthy volunteer". In cases where clear consent has been obtained, breach of GDPR is unlikely, but care should be exercised where anonymised or pseudo-anonymised data is used. If a patient can be identified and a breach occurs, the Information Commissioner’s Office (ICO) may need to be informed.

Is your record keeping adequate? Clear and accurate records are essential for any research, to support it at the time and possibly as evidence years later.

CONFLICTS OF INTEREST

Another area which can cause difficulties and attract criticism is conflict of interest. GMC guidance (Financial and commercial arrangements and conflicts of interest) states you should identify and avoid conflicts of interest that arise wherever possible, and declare conflicts to anyone affected, formally and as early as possible, in line with the policies of your employer or the organisation contracting your services.

You should also seek advice on the implications of any potential conflict of interest and ensure it does not affect decisions about patient care.

The GMC further states that any actual or potential conflicts of interest should be declared to a research ethics committee, other appropriate bodies and the participants, in line with the policy of your employing or contracting body.

Dr Gail Gilmartin is a medical and risk adviser at MDDUS