Research Ethics in Medical Studies

A set of ethical guidelines, developed after the inhumane medical practices during World War II, that establish fundamental principles for conducting research involving human subjects.

An international document that outlines ethical principles for medical research involving human participants, including research using identifiable human material or data.

The document is primarily for physicians, but it emphasizes that these ethical standards should be followed by anyone involved in medical research.

The primary goal of medical research involving humans is to generate knowledge that improves health and treatment, but these goals should never compromise the rights and well-being of participants.

Even established medical practices need constant reevaluation through research to ensure their safety, effectiveness, and efficiency.

Medical research involving humans must adhere to ethical standards that protect participants' health and rights.

The Declaration of Helsinki emphasizes prioritizing the well-being of patients, even in research settings, and respecting their rights and autonomy.

The Hippocratic oath, a cornerstone of medical ethics, binds physicians to prioritize the health and well-being of their patients.

Ethical principles in the Declaration of Helsinki remain crucial even during public health emergencies, despite the need for new knowledge and interventions.

Physicians in medical research are responsible for participants' safety, health, dignity, privacy, and confidentiality. This responsibility cannot be transferred to participants, even with consent.

Medical research involving humans must adhere to ethical, legal, and regulatory norms of the origin and performance countries, as well as international standards.

Medical research should be designed to minimize harm to the environment and aim for sustainability.

Only individuals with appropriate ethics, scientific education, training, and qualifications should conduct human research. It must be supervised by a competent and qualified physician or researcher.

Groups underrepresented in medical research should be given access to participate.

Physicians conducting research involving patients should ensure that participation is justified by its potential benefits and does not harm their health.

Compensation and treatment should be provided to participants who are harmed by research.

In medical research, the potential benefits for participants and society should outweigh the risks involved.

Before involving humans in research, scientists must carefully assess the potential dangers and burdens participants might face.

Researchers must ensure they can manage and minimize the risks identified during the research process.

Research involving vulnerable individuals, groups, or communities requires careful consideration to ensure their rights and wellbeing are protected.

Scientists must weigh the potential harms of excluding vulnerable groups from research against the risks of inclusion. Excluding them could worsen existing health disparities.

Research with vulnerable groups should be designed to address their specific health needs and priorities, ensuring they benefit from the knowledge generated.

Research should focus on generating reliable, valid, and valuable knowledge, ensuring efficiency and preventing wasted resources.

Research involving human participants must be designed and executed with a focus on high-quality and ethical standards.

Research must be grounded in established scientific methods, and rely on thorough literature review, relevant information, and adequate laboratory testing.

Animal research is permitted if it is deemed necessary and conducted ethically, prioritising their well-being.

A detailed plan outlining the aims, methods, anticipated benefits, risks, and other important aspects of human research. It also covers ethical considerations and participant protections.

This committee reviews and approves research protocols to ensure ethical conduct and safeguard participants' welfare.

Protecting the privacy of participants and ensuring confidentiality of their personal information is crucial.

Individuals must freely choose to participate in research, fully understanding the risks, benefits, and procedures involved.

Family members or community representatives might be consulted for guidance, but individuals capable of consenting must give their own agreement.

In clinical trials, the protocol must include details about what happens to participants after the trial ends.

Researchers must publicly share the results of their research on human participants, regardless of whether the findings are positive, negative, or inconclusive. This ensures transparency and allows others to learn from the research.

Before any human participants are recruited, medical research involving humans must be registered in a publicly accessible database. This helps track research and prevent duplication of effort.

When a new treatment or intervention is used outside of a clinical trial to treat a patient, it should be documented and become the subject of future research to assess its safety and effectiveness. This process ensures responsible use of unproven therapies.

Participants in research must be fully informed of the potential risks, benefits, and procedures involved. This includes disclosure of any post-trial provisions, if applicable.

Researchers, authors, sponsors, editors, and publishers play important roles in ethical reporting of research. They must adhere to accepted guidelines, ensuring the accuracy, completeness, and timeliness of published results.

Research can proceed without informed consent if a representative is unavailable, the research cannot be delayed, and the reasons for involving participants unable to consent are clearly stated.

Researchers must inform participants about research-related aspects of their care. Refusal or withdrawal from research should not affect patient-physician relationships or care.

Researchers must obtain free and informed consent for collecting, processing, storing, and using biological material and identifiable data. The use of data and biobanks must comply with the WMA Declaration of Taipei.

A new intervention should be tested against existing proven interventions unless there is no proven intervention, compelling scientific reasons, or no additional risk for participants receiving alternative treatments.

The benefits, risks, burdens, and effectiveness of a new intervention must be tested against those of the best proven intervention(s).

Researchers may use placebo or no intervention in a trial if no proven intervention exists or if compelling scientific reasons justify it, and participants receiving alternatives don't face additional serious risks.

A research ethics committee must approve the establishment and monitor the ongoing use of databases and biobanks that collect and store biological material and identifiable data from research participants for multiple and indefinite uses.