Code of Federal Regulations, Essay Example

The Code of Federal Regulations classifies research proposals in a manner that allows the Institutional Review Board to determine whether a proposed research project is ethical. In certain situations, a full review by the board is not necessary if the project results in no health concerns for its participants and has the potential to serve an immediate benefit to the target population. My DNP project falls under this category because it aims to determine the effects of baby friendly initiative and breastfeeding. The proposed intervention has no potential for causing detriment to the mother or her child. Under 45 CFR 46 101 (b), this program would be exempt because it would result in “possible changes in methods or levels of payment for benefits or services under those programs” (Code of Federal Regulations, 2009).

I believe that the classifications set forth in the Code of Federal Regulations is necessary to ensure that human participants in research projects remain protected. This process ensures that if there are risks present in a particular study, that participants are aware of the potential hazards. Generally, this indicates that a project that can cause potential harm will only be approved if there are documented potential benefits that outweigh these detriments. While many DNP projects operate in a manner that is based on observation or data collection, it is necessary to ensure that research projects that utilize medical interventions are well-planned to yield reasonable results and to protect patients throughout the process. The Institutional Review Board is a useful partner in this process, as they are a panel of professionals that are able to help researchers determine which ethical and design considerations have been overlooked (Pope, 2009).

References

Code of Federal Regulations. (2009). Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101

Pope, T. M. (2009). Multi-Institutional Healthcare Ethics Committees: The Procedurally Fair Internal Dispute Resolution Mechanism. Campbell Law Review.