According to the federal regulations, research is eligible for exemption, if:

According to the federal regulations, research is eligible for exemption, if:

A. All the subjects are adults and the risk is minimal:

B. Participation in the research will involve cen minutes or less of the subjects time.

C. The researcher is experienced in the field of inquiry

D. The research falls sinto one of eight categories of rescarch activity described in The regulations?

Answer: D. The research falls sinto one of eight categories of rescarch activity described in The regulations?

This option best defines the federal regulations about human subject’s research. Thus, if the regulations are adhered to in the letter, research is only exempt if it falls within any of the core categories of exempt research activities. These categories are developed in detail to encompass the trials that are not very risky to the subjects and do not qualify for the full protection of the Common Rule.

Each of the eight exempt categories pertains to different kinds of research. For example, one category comprises specific education practices research; this may consist of research carried out on routine teaching or instruction strategies or classroom management practices. The second is research that presents us with non-invasive manipulations of the participants’ behaviour that concern only adults. Another exception is a secondary research use that includes identifiable private information or biospecimens, but only if the research is for the following:

However, this does not necessarily mean that research in any of the above can go without limited IRB review to affirm its exemption. Moreover, some categories state certain restrictions or conditions connected with their utilization. For example, studies conducted on children may be eligible for exemption under some categories but not in others.

Essential studies that can be exempted are questionnaires completed on the internet and of a non-sensitive nature, analysis of publicly available databases, and studies concerning the preference for certain tastes. Still, a study that involves deception or one that gathers any person’s sensitive data is unlikely to be quality, even if it aligns with one of the categories.

It is necessary to differentiate between these categories for the convenience of the researcher, as well as for future studies that may fit the criteria for exemption, thus saving time on the review. Nonetheless, researchers must ask their Institutional Review Board or ethics committee to determine whether their study falls under the true exemption as provided in the six categories or not because the definition and use of the six categories are sometimes equivocal and relativity.


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