Scientific Requirements and Research Protocols These groups may include minor children, the imprisoned, those with intellectual or physical disabilities, as well as racial or ethnic minorities who may face systemic injustice. Special protections must be implemented to protect some individuals and groups who are particularly vulnerable with a higher likelihood of becoming wronged or incurring additional harm due to their status. Risks must be monitored, mitigated, and if beginning to outweigh the potential benefits, the study must be immediately modified or stopped. This involves reflecting on the impacts on the individual participating, as well as the potential benefits to them and others who may be similarly affected by the disease. Medical research must only be conducted if the importance of the findings outweigh the risks and burdens to the research subjects. There are 10 specific topic areas addressed within the Declaration of Helsinki as it presently exists, outlined as follows: Risks, Burdens and Benefits These requirements should not diminish the protections set forth in the Declaration of Helsinki, but additional protections may be afforded. Physician scientists must also take into account their local ethical, legal, and regulatory norms and standards for research involving human subjects. If harm occurs, appropriate compensation and treatment for subjects must be provided. Underrepresented groups should be provided adequate access to the research opportunities. When the research is conducted, it must also minimize potential harm to the environment. In most cases, this should be supervised by a qualified physician or health care professional. Medical research involving humans should only be conducted by individuals with appropriate scientific and ethical education, training, and qualifications. In order to achieve this, specific considerations must be taken into account.
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