Medical and health research come with many ethical considerations for which appropriate ethical approval is required. Understanding these ethical issues will help in conducting your own research and when critically reading scientific articles. My research involved human participants, therefore, is considered high risk in my university preliminary ethics application. I am now in the process of undertaking the full ethics application and I aim to share some of the key elements within it.
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical guidelines for medical research adopted by the World Medical Association in 1964. These are the guidelines which all researchers must adhere to when conducting Medical research. It stemmed from the Nuremberg Trials which took place after doctors conducted horrific experiments on concentration camp victims in Nazi Germany. These trials brought about the Nuremberg Code setting out the standards to which physicians must conform when carrying out experiments on human subjects. The DoH goes through everything from risks and benefits, vulnerable groups, privacy, informed consent, placebo and many more aspects of research which form the outline of ethics applications.
Risks and Benefits
Risks and benefits should be clearly detailed in the protocol of the research and explained to the participants. These are risks during and after the research. Medical research can only be conducted in the importance of the objectives and the benefits outweigh the risks and burdens of the research. If more harm is caused by the research, then that research is not ethical and must not be carried out.
Withholding risks from the participants or in the protocol in unethical. With each risk that comes with the research, measures to control those risks should be detailed. For example in my research talking to participants about mental health may incite certain emotions in the participants and we may find mental health conditions of concern in some participants. Therefore, measures to control will be put in place such as healthcare providers at hand and referrals to psychiatrists where needed.
Before conducting any research on human participants, informed consent from the participant is an absolute must. The participant should be fully aware of the research, the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. They should be informed from the start that participation is totally voluntary, they have the right to refuse or withdraw at any point and they will not be at any disadvantage if they do not participate.
After knowing making sure the participant is fully aware of the research, the researcher should aim to obtain freely-given consent, preferably in writing. If written consent cannot be provided then non-written consent must be obtained with proper documentation and witnesses. This can be in the form of recordings, thumb prints etc.
When a participant is incapable of giving informed consent, consent must be taken from a legal representative, for example the legal guardian of a child, and it must be highlighted that this representative is not gaining anything from the research so they are totally unbiased in giving consent.
Privacy, Confidentiality and Anonymity
Proper privacy, confidentiality and anonymity is crucial in medical research. Any information taken from the participants must be stored and locked away securely with access given to only the key researchers. Only the absolutely necessary information should be taken from the participants, particularly when it comes identifiable information, and where possible identifiable information should not be seen by anyone, instead use codes.
When collecting data from participants, for example in an interview, ensure the location is somewhere private and safe so that the participant feels comfortable in sharing information.
Research with vulnerable groups should be properly justified, ensuring adequate safety and meeting any specific needs they have. If the same research can be conducted on non-vulnerable groups then it is unethical to use vulnerable participants. It should be specific to the needs of the vulnerable groups. The group should stand to benefit from the research.
Appropriate measures should be put in place beforehand to minimise and control the potential risks. Where appropriate guardians should be informed of the participation, however, make sure telling the guardian is not putting participants in addition risk, for example in the case of abuse.
The effectiveness of a new intervention should always be tested against the best proven intervention, unless, there are no best proven interventions or there is proper scientific evidence that a placebo is necessary, then a placebo may be used. The patients who are given the placebo should be not placed at any other disadvantages, risks or irreversible harm from not receiving the best proven intervention.
Recruiting more participants than required for study power is also unethical as you are making more people take the placebo when it is not needed.
Elements to include in an Ethics Application
-Aims & objectives
-Study design & methodology: including interventions, procedures, time-scale, recruitment, sampling, inclusion, exclusion
-All instruments used to collect data: questionnaires, interview topic guides etc
-Risks & benefits with control measures for the potential risks
-Data management & Analysis
-Expected outcomes & dissemination
-Informed consent forms