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Research involving Human Participants

The dignity, rights, safety and well-being of participants must be the primary consideration in any study. 

Historical events have shaped the evolving legislation and regulation that we currently have today. Many prominent medical researchers in the 19th and 20th centuries conducted experiments on patients without their consent, and with little if any concern for the patients’ well-being. Physicians in Nazi Germany and elsewhere performed research on subjects that clearly violated fundamental human rights.

Following WWII some of these physicians were tried and convicted at Nuremberg, Germany, and the basis of the judgement is known as the Nuremberg Code. This has served as one of the fundamental documents of modern research ethics.

Following this a set of principles were adopted which in 1964 translated into the Declaration of Helsinki (as revised). These principles have been incorporated into legislation and regulation of many countries.

The key principle is that every proposal for medical research on human subjects must be reviewed and approved by an independent ethics committee.

The University is committed to ensuring that its research activities involving human participants are conducted in a way which respects the dignity, rights, and welfare of participants, and which minimises risk to participants, researchers, third parties, and to the University itself. A Criminal Records Bureau (CRB) check may also be required, if you come into contact with children or vulnerable adults as part of the research. View the DBS Disclosure Service.

Any study involving human participants whether these are recruited via the NHS, through an NHS resource or from elsewhere, or where the study involves NHS staff or facilities, must be ethically approved by an appropriate research ethics committee. If there is doubt about whether a project requires ethical approval please contact the Research Governance Team in R&IS.

Protection of Participants.

Researchers have a responsibility to protect participants from any harm arising from research. Harm to participants may arise from undue stress through participation, loss of self esteem, psychological injury as well as physical harm. As a general rule, people participating in a study must not be exposed to risks that are greater than or additional to those they encounter in their normal lifestyles.

If it is expected that harm, unusual discomfort or other negative consequences might occur in the prospective participant’s future life as a result of participating, the lead researcher must, prior to the person’s participation, obtain:

Before participating, people must be informed of procedures for contacting the lead researcher/Research Governance Office, within a reasonable time, if following participation they experience stress, harm or have related concerns.

In the case of clinical trials, research can only take place where the foreseeable risks and inconveniences to the prospective trial participants/patients are outweighed by the potential benefits for them and for future patients. In certain cases a patient may explicitly support a study and support invasive treatment that may be very harmful if, due to the particular circumstances (e.g. s/he is terminally ill), s/he feels that it is worth taking a significant, potentially life-threatening risk.

In the case of non-invasive research methods such as interviews and questionnaires, the content and line of questioning may be highly sensitive, raise confidential, personal issues and intrude, or be perceived to intrude, upon a participant’s comfort and privacy. The initial judgment, on whether or not questions are sensitive and likely to cause harm rests with a lead researcher. For advice the lead researcher should consult the relevant University Research Ethics Committee.

Debriefing

Debriefing does not provide a justification for unethical aspects of research but is rather a means for researchers to discuss with participants their experience of the research and to monitor any unforeseen negative effects or misconceptions. Debriefing is particularly important where any form of deception has been used and researchers have a responsibility to ensure that participants have received any necessary debriefing in the form of active intervention before they leave the research setting.