Ethics of medical research

Informed consent, confidentiality, privacy, respect and responsibility are key elements of ethics in research

Ethics of medical research


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number of challenges are encountered when research is conducted; starting from its planning to reporting. Ethical issues can arise at every step. From designing a study or developing questions leading to specific answers, recruitment of participants i.e. their inclusion and exclusion criteria, data collection and its interpretation, authorship issues and what impact the results of a particular research will have on others. The main purpose is to maximise the benefits and minimise conflict of interests or risks to participants and society.

The risk is greater when research is conducted in low- and middle-income countries (LMICs). This is due to the unequal power dynamics. Researchers from high-income countries may hold more power and resources, leading to imbalanced partnerships prioritising their interests over the needs of the local population.

Participants from the LMICs, especially those from economically disadvantaged backgrounds, may agree to research without fully understanding the risks due to language barriers or lack of education. They may also not be compensated fairly for the time and energy they spent.

Research results may primarily benefit external stakeholders and local communities may not see any benefit from the research. This may have a direct impact on their healthcare, infrastructure, or knowledge-sharing. It could be due to imposing foreign solutions that don’t fit local realities or failing to consider cultural, social or economic factors, which may make the research irrelevant or harmful to the local community.

The collected data may be used solely by the external stakeholders or donors without giving ownership or acknowledgement to the local contributors. This means depriving local researchers of opportunities to publish or benefit from the research.

Learning from the past

Cases like the Tuskegee experiment are a prime example. Tuskegee was a syphilis study which began in 1932, a time when no syphilis treatment was available. Approximately 600 participants, mostly African-American, were recruited and monitored for years. Penicillin became available for syphilis treatment in 1947; however, the study participants were not treated with it. The reason for not providing treatment to any participants was to assess the progress of the disease. The study lasted almost 40 years and ended in 1972 when a reporter exposed this unethical approach and published the story in a newspaper. The damage and suffering caused by this study were significant. More than 100 participants died due to the disease or its complications. A number of new cases were identified in partners /spouses of study participants and vertical transmission i.e. from mother to child was seen in 19 cases. Similarly, the Nazi human experiments (1942-1945) were conducted on the prisoners in the concentration camps. As per published literature, there were over 15,000 victims. The purpose of reminding ourselves of such historical events is to be mindful of the ethical issues that can emerge at every step of our research projects.

As a result of these events, a number of reforms were introduced in the field of medical research, like the declaration of Helsinki and Belmont reports, which define the ethical principles for involving human subjects in medical experiments. These ethical standards or guidelines are applicable to all researchers who deal with projects involving human subjects, including vulnerable groups, and promote the protection of human rights and health. It is now mandatory for a researcher/ physician to seek the ethics review committee’s or institutional review board’s approval for their research proposals on biomedical or behavioural sciences involving human subjects prior to commencing data gathering.

It is important that participants understand the relevant details of the study, any intervention, risks and benefits of an intervention or procedure and give informed consent. 

It is, therefore, important to know the set of principles that guides us in carrying out various procedures. Educational institutions and healthcare facilities involved in research must promote ethical research practices. They can help in fostering genuine partnerships, transparency, fair compensation and ensuring tangible benefits to the local population.

By incorporating the following key principles the ethical review boards can ensure that research in resource-limited settings especially in LMICs can be conducted ethically and respectfully.

Community engagement

Involve local communities in the design, implementation and evaluation of research to ensure that it aligns with their needs and values.

Informed consent

Ensure that participants fully understand the research, its risks and benefits, considering local literacy levels and cultural contexts.

Capacity building

Training and employing local researchers and healthcare workers will help to develop local expertise and reduce the dependence on external researchers.

Fair compensation

Participants and local collaborators should be fairly compensated to ensure they are not exploited due to their economic vulnerability.

Respect for local regulations and ethics boards

Adhere to local laws and work with local ethics committees to ensure cultural appropriateness.

Data sharing and ownership

Ensure that data collected is shared with local researchers and institutions, respecting their right to co-ownership of the research outcomes.

In addition to obtaining written consent from study participants, it is important that the participants understand the relevant details of the study project, any intervention, risks and benefits of an intervention or procedure and give informed consent. It is also vital to reassure them that personal details will be kept private and measures are in place to keep confidential data secure.

Another important concern is plagiarism. This must be avoided when publishing research. Plagiarism is illegal and involves using someone else’s idea and claiming it to be your own. There are softwares that can assess the extent of copy and paste by authors. These must be used prior to submitting a manuscript to journals. If it is found after publication, it can lead to disciplinary action by the institution and a poor reputation of all authors involved in the paper.

There can be multiple authors in a medical/ scientific journal article. Their inclusion depends on their significant contribution and follows set criteria. It is the collective responsibility of all authors to meet the criteria and avoid issues like ghost, guest or disputed authorship.

To maintain academic integrity, strict adherence to research ethics is necessary. Research ethics training must be initiated at the undergraduate level and continue throughout the postgraduate period. Both undergraduate and postgraduate researchers/ residents must be aware of the processes involved in research ethics processes. Their training in research and publication ethics must be considered in order to improve overall research quality. Residents must be groomed in research projects leading to original articles. Deficiencies in synopsis and thesis writing skills must be addressed at the institutional level. Such measures will motivate postgraduate residents and lead to improvement in their research activities and abilities.


Dr Hina Jawaid is an associate professor in family medicine at Health Services Academy, Islamabad.

Dr Abdul Jalil Khan is an associate professor in family medicine at Khyber Medical University, Peshawar

Ethics of medical research