Final answer:
Biomedical research involving human subjects aims to test new interventions, set dosages, identify side effects, and further medical knowledge, differing from medical treatment that seeks immediate therapeutic benefit. The Informed Consent (IC) was established to protect the rights and safety of participants, and IRBs review research proposals to ensure ethical adherence.
Step-by-step explanation:
Goals of Biomedical Research Involving Human Subjects and Its Distinction From Medical Treatment
The three primary goals of biomedical research involving human subjects are to:
- Test new medical interventions and establish a drug's safety and efficacy.
- Determine optimal dosages and identify potential side effects.
- Contribute to medical knowledge and potentially provide important results for society.
Biomedical research is distinct from medical treatment in that the primary aim is to gain new knowledge that may benefit individuals in the future, rather than provide immediate therapeutic benefits to the study participants.
Why do you think the IC for research was created? The Informed Consent (IC) for research was created to protect participants in research studies by ensuring that they are fully informed and voluntarily consenting to their involvement, acknowledging the purpose, risks, and benefits of the study.
Ethical Considerations and Safeguards in Human Subjects Research
Key ethical considerations in research with human participants include voluntary participation, fair selection, preservation of confidentiality, risk minimization, and ensuring that the research has societal value. The creation of Institutional Review Boards (IRBs) and guidelines for clinical trials are responses to historical ethical breaches in research and a growing understanding of the importance of human dignity and rights in the research context.
These ethical principles and institutional safeguards are in place to ensure that human subjects are not exploited and are treated with respect, aligning with the notion that humans should not be used merely as a means to an end. Furthermore, these measures help maintain the integrity of the scientific process by assuring that research is conducted ethically, safely, and with consideration for the well-being of participants.