Principles of biomedical research ethics
COLLAPSE
Ethics are the norms or standards for conduct that helpsto distinguish between acceptable and unacceptable acts. Therefore, ethical considerations in research are extremely important. The three guidig ethical principles of biomedical research are respect for people, beneficence, and distributive justice (Mardani et el., 2019).
1-Respect for person autonomy:
In research, respect for person’s autonomy means that patient will be involved in the research intentionally with understanding, and without controlling influences that could affect patient’s choice. This can be translated practically to informed consent (Mardani et el., 2019)
2-Beneficence
Beneficence means to provide the patient with the maximum benefit and to remove any harm from the patient or minimize it as possible. Another ethical principle is nonmaleficence which is a constant duty to never harm another individual (Mardani et el., 2019)
3- Justice Usually, fairness is another term for justice in the context of health care. In healthcare, distributive justice is a concept in which the resource should be distributed fairly. The issue of distributive justice also appears to be dependent on finding fair ways to distribute limited resources because some products and services are in low supply and cannot be distributed equally (Mardani et el., 2019).
Informed consent should include a description about the procedure and the future consequences, benefits and possible harms. Other things that should be considered is to ensure patient’s privacy and to maintain confidentiality. Privacy is the assurance that individuals get to choose what information they reveal about themselves and they have the full right to refuse sharing any information. In addition, patient has the full right to ask that the interview should be privately without the involvement of any other participants. Most importantly, patient’s identity should not disclosed to unauthorized people (Mardani et el., 2019). Confidentiality is the protection of personal information provided to researchers even for the types of researches that the participants should be followed over the time such as longitudinal studies (Mardani et el., 2019). Moreover, a research protocol must be appropriate to the culture or cultures of the expected study participants. For example, In Saudi Arabia it is important to consider the gender of the patients and the investigators especially in cases that the research intervention may include doing physical assessment. A study protocol that targets a potentially vulnerable population must demonstrate the need for the project, guarantee fair sampling, ensure that participation is voluntarily given, and ensure that volunteers (and/or their legal representatives) are aware of the requirements for participation as well as any potential benefits and risks and all of this should be documented clearly and simply in the consent form (Mardani et el., 2019).
References:
Mardani, A., Nakhoda, M., Noruzi, A., & Shamsi Gooshki, E. (2019). Ethical considerations in the biomedical research: analysis of national biomedical research ethics guidelines in Iran. Journal of medical ethics and history of medicine, 12, 4.