Medical Research: Ethical Regulations
Many a times, medical research involves testing that can be hazardous. Clinical trial, for example, often involves human volunteers for studying the effects and dosage of new medications. There are a number of clearances that have to be taken by medical researchers before conducting a test. Such clearances can be taken from:
• Medical Associations at local or national level
• Governing bodies for such research
• Organisation with which the researcher is associated
• Funding authorities
• Approvals from patients who are involved in research and their families
For getting the approval, researchers will have to submit a well formatted document, disclosing the potential risk factors to which participants can be exposed, the material and equipment being used, duration of research and other pertinent details. Once they have gained the requisite clearances, they can go ahead with the study. However, even during the course of research, some principles will have to be followed. Read on to know about these ethical guidelines:
• Validity of research: while it is important for all research projects, validity becomes a critical point when it comes to medical studies. When taking up a study, researchers must consider whether they have chosen the variables correctly, methods are reliable and data analysis tools are valid. Every aspect must be measurable and in sync with the objectives.
• Risk vs. Benefits: the quantum of exposure to risk must be well calculated. Also, researchers must ensure that the outcome of research will be beneficial for the participant group, as well as others. Further, all steps must be taken to minimise the risk and enhance advantages.
• Purpose of study: every medical research project must have a clear objective and contribute something to the society, or to the field of knowledge. The goals must be stated without ambiguity and the researcher must be sure of attaining such results. Only when a substantial contribution is made, the study and the risks attached to it become worthwhile.
• Selecting participants: for a clinical trial, or other research involving human participants, people must be selected in an unbiased manner. While specific groups must not be excluded from the study without any sound reason, no one must be forced to participate.
• Informed decision: all participants must be given complete information about the risks and benefits accruing from the research work. In case there is any change in the factors during the course of the study, the same must be disclosed. Participants must, under all circumstances, be free to take their decision regarding involvement in the project.
• Respecting Privacy: information about the participants should be kept confidential. Disclosing or using such information without their knowledge is unethical. In fact, researchers must respect the decisions of the participants too. Even if they decide to opt out of the study at some point due to some risks involved, researchers have no right to object.
Following these ethics will ensure that your medical research work has a strong base and gains acceptance.