Melissa Rosales
Director General
RM Pharma
/
Expert Contributor

Ethics and Human Subject Protection in Clinical Research

By Melissa Rosales | Thu, 02/11/2021 - 13:18

Concerns about ethics in the practice of medicine have a long history but until the mid-20th century, they were mostly centered around the practice of therapeutic medicine, not research medicine. In 1946, 23 Nazi physicians went on trial at Nuremberg for crimes committed against prisoners of war and in concentration camps. These crimes included exposure of humans to extreme temperatures, performance of mutilating surgery, and deliberate infection with lethal pathogens. During the trial, fundamental ethical standards for the conduct of research involving humans were codified into the Nuremberg Code, which set forth 10 conditions that must be met to justify research involving human subjects. Two important conditions are the need for voluntary informed consent of subjects and a scientifically valid research design that can produce fruitful results for the good of society.

The World Health Organization recognized a need for guidelines that were broader in scope than the Nuremberg Code. The Declaration of Helsinki recommendations guiding medical doctors in biomedical research involving human subjects was adopted by the World Medical Society in 1964. These guidelines have been revised a number of times and are in use throughout the world.

Ethics is important in clinical research, and guidelines have been developed to provide clarity because many people are involved in a clinical trial, as these are complex projects that need different professionals with different skill sets to ensure a successful outcome. A trial is considered a success when the patient’s rights, safety and well-being are safeguarded at all times.

A trial is also considered a success when high quality data is gathered within the foreseen time frames, and when the trial is conducted according to the applicable regulatory requirements and guidelines at every stage.

The fundamental principles of human research ethics start with informed consent and respecting the privacy and protection of vulnerable subjects. Other principles are to:

  • treat individuals as autonomous human beings and do not use them as a means to an end.
  • allow them to choose for themselves and provide extra protection to vulnerable subjects such as people with limited mental capacity.
  • use beneficence, this means using the best possible research design and capable researchers.
  • minimize harm and maximize benefits physically.
  • exercise justice, protect vulnerable populations and equitable distribution of risks and benefits.
  • and lastly, use a research design to ensure burdens and benefits are shared equitably.

Ethics committees are established as governing bodies to ensure that clinical trials are carried out ethically. Their primary role is ensuring protection of human subjects, and for this they must take into consideration the laws and regulations of the countries conducting the research.

According to the International Council on Harmonisation, an international quality standard for research implementation, Good Clinical Practice guidelines defines an International Ethics Committee as an independent body constituted of medical, scientific and nonscientific members whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial. They do this by, among other things, reviewing, approving and providing continuing evaluation of trial protocols and amendments. They also review and approve the methods and materials used in obtaining and documenting the informed consent of the trial subjects.

Bioethics in Mexico has a history that reveals the vision and ethical commitment of iconic characters in the fields of health sciences and humanities, leading to the creation of the National Bioethics Commission responsible for promoting a bioethics culture in Mexico.

The General Health Law contemplates the mandatory nature of establishments dedicated to the healthcare of the public, social or private sectors that form the National Health System to incorporate Hospital Bioethics Committees and Research Ethics Committees with these general considerations:

  • It is specified that both committees must be interdisciplinary, and must be integrated by medical personnel of different specialties, people of diverse professions and should include society representatives in terms of health services users or participants in studies or research projects.
  • Besides being trained in bioethics, the members of the committees must be balanced in terms of gender, and they may be able to be attached or not to the health unit or establishment.
  • Their performance will comply with the current legislation and the criteria established by the National Bioethics Commission.

In this way, the National Commission of Bioethics establishes the criteria for the integration, operation and registration process, through the National Guide to the Integration and Functioning of the Committees Ethics in Research, which began on Jan. 11, 2016. Since then and until Dec. 8, 2020, there have been 362 records sent to Research Ethics Committees installed in 32 federal entities.

RM Pharma Specialists decided to establish a committee and began with all the documentation necessary to submit to CONBIOETICA and obtain registration. The process began with the reception of the initial package on Nov. 19, 2019. We received a notification on July 31, 2020, that they required some clarifications to the manual and the last three approvals of clinical research protocols by COFEPRIS in order to demonstrate that we conduct clinical studies. We waited a few more months until finally, on Oct. 2, we received our registration.

The committee’s first meeting was on Jan. 19 of this year for a phase 3 study of rheumatoid arthritis. We already have our second protocol for review in the area of ophthalmology. We use an electronic platform called e-komite that makes administrative work easier and we can receive documentation on it.

This year, we will be focused on the continuing education of the members of our committee, which includes two specialist doctors, one biologist, one lawyer, one social worker and two community representatives (a housewife and an engineer).

Mexico has crystallized the need to protect people during the progress of science and the right to health using different policy instruments that have enabled a broad and robust bioethics infrastructure to be consolidated as having sufficient capacity to respond to the new challenges in protecting human rights imposed by technological advancement, especially in the field of biomedical research. Ethical committees guarantee protection of dignity, security, rights and well-being for people who already participate as subjects in research and for those who could potentially do so