The protection of human subjects who enroll voluntarily in research studies is paramount. Human subjects who agree to advance the cause of science can be harmed. Therefore, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research drafted a set of guidelines (the Belmont Report) for the ethical conduct of research including three key principles: respect for persons, beneficence and justice. The Belmont report was subsequently adopted by the U.S. Department of Health and Human Services as reulations governing all research involving human subjects supported or conducted by the Department. All U.S. government funded human subjects research, domestic and international is governed by a Commom Rule that sets forth requirements for: review by an Institutional Review Board (IRB), informed consent, and additional protections for vulnerable populations. Polit and Beck (2011) identified the following people as vulnerable populations: children, mentally or emotionally disabled people, severely ill or physically disabled people, the terminally ill, institutionalized people, and pregnant women.

Before researchers undertake a study, they must submit research plans to IRB to ensure that proposed plans meet federal requirements for ethical research. The IRB system was developed some 40 years ago to protect those who enroll in clinical, social/ behavioral, and other types of research. The main requirements governing IRB decisions may be summarized as follows:

1. Risks to participants are minimized.

2. Risks to participants are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result.

3. Selection of participants are equitable.

4. Informed consent will be sought, as required, and appropriately documented.

5. Adequate provision is made for monitoring the research to ensure participants’ safety.

6. Appropriate provisions are made to protect participants’ privacy and confidentiality of the data.

7. When vulnerable groups are involved, appropriate additional safeguards are included to protect their rights and welfare.

In addition to IRBs, researchers may have to communicate information about ethical aspects of their studies to other review boards such as the Privacy Boards to review researchers’ compliance with provisions in HIPAA, including review of authorization forms and requests for waivers. The National Institutes of Health also requires that NIH-supported projects must meet the current human subjects protections requirements. Grant applications for research conducted in the U.S. or internationally must describe the following: the risks to any human subjects enrolled in the study, the protections the researchers will provide those risks, and the potential benefits of the proposed research to the subjects and others. For researchers evaluating interventions in clinical trials, NIH requires review by a Data and Safety Monitoring Board (DSMB). Polit and Beck (2011) explained the purpose of DSMB that is to oversee the safety of the participants, to promote data integrity, and to review accumulated outcome data on a regualr basis to determine whether study protocols should be altered or the study stopped altogether.


Original Discussion Question:

Conducting research projects while ensuring the protection of human subjects is necessary. What are some methods to protect personal rights of someone in one of the groups that is labeled as vulnerable? Justify your rationale.


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