Informed consent benefit-risk assessment

The informed consent document is where we ask patients to make their own benefit-risk assess-... 

In the United States it was as a direct result of the revelation of the Tuskegee Syphilis Study that the next U.S. medical ethics initiative emerged. The National Research Act of 1974 was passed (Public Law 93348), which required regulatory protection for human subjects and created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979 this commission produced the Belmont Report, named after the Smithsonian Institution s Conference Center, where the discussions were first held in 1976. The report established three ethical principles to allow problems to be solved in the area of ethics in clinical research (1) respect for persons, (2) beneficence, and (3) justice. In general terms, these categories were equivalent to informed consent, risk-benefit assessment, and an appropriate choice of subjects for the research. 

Other findings indicate that many researchers and organizations failed to comply with clinical protocols for carefully assessing and selecting patients for the trials and for monitoring them thereafter. Additionally, it was found that many doctors had failed to fully inform prospective patients of uncertainties about the benefits and risks of the therapies or other relevant information (e.g., that other enrolled patients and test animals had suffered adverse events). Thus, doctors had enrolled patients without their informed consent to medical experimentation in violation of clinical protocols and medical ethics. 

Parents who perceived that they have insufficient time or privacy to make a decision tend to assess the risk and benefit in a more negative light (Hoehn et al., 2005). This is partly a result of stress parents who were anxious were more likely to decline their child s participation (Tait et al., 2003). This would explain why parents are more likely to give consent in an inpatient setting than in an outpatient preoperative setting (Tait et al., 1998), where there was little time and lack of privacy to ponder the issue. Every effort should be made to provide information in an unhurried manner to alleviate anxiety. 

If the intention is to collect information from students which might or will result in publication or presentation in a public or professional forum, then IRB oversight is often required. The IRB review assesses the risks and benefits for students in light of the purpose and nature of the study and determines what level of student consent is required. One issue that should not be forgotten is that faculty instructors are human subjects, too. If courses involving different instructors are to be compared, there are risks for the instructors and their consent is also required. 

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