According to the federal regulations, research is eligible for exemption, if: all the subjects are adults and the risk is minimal. the investigator is experienced in the field of inquiry. participation in the research will involve 10 minutes or less of the subjects' time. the research falls into one of six categories of research activity described in the regulations. the research falls into one of six categories of research activity described in the regulations.

The correct answer is: "The research falls into one of six categories of research activity described in the regulations".

Researchs which are declared to be exempt are initially reviewed by IRB, but no more reviews would be conducted afterwards. First of all, if a project does not meet the requirements defined for a research with human subjects is directly excluded from the IRB review. Independently if the research qualifies or not as exempt it must follow some minimum ethical standards, such as: the research is minimal risk, the selection of participants is equitable, etc.

The headings of the categories defined for a research to be declared exempt are the following (then under each heading several provisions are detailed):

According to the federal regulations, research is eligible for exemption, if the research falls into one of six categories of research activity described in the regulations. It can be seen through 45 CFR 46.101(b).

EXPLANATION:  

Here is the list of each category:

•Category 1

Research conducted in a built or generally accepted educational environment that includes normal educational practices, such as a) research on special and regular education instructional strategies, or b) research on comparison or effectiveness between instructional curriculum, techniques, or classroom management methods.

•Category 2

Research includes the use of educational tests (diagnostic, cognitive, aptitude, achievement), interview procedures, survey procedures, or observation of public behavior,

•Category 3

All research include the use of educational tests (diagnostic, cognitive, achievement, aptitude), survey observation or procedures of public behavior that is not excluded in category 2 above, a) if the human subject is appointed or chosen by a public candidates or officials for a public office; or b) the federal code requires without exemption that the discretion of personally identifiable information will be sustained throughout the study and thereafter.

•Category 4

Research includes the set or study of existing data, records, documents, diagnostic specimens, or pathological specimens, if these sources are openly available or if the information is verified by investigators in such a way that subjects cannot be classified, directly or via identifiers related to the subjects.

•Category 5

Research and demonstration projects conducted by or subject to authorization from the Department of Health and Human Services (DHHS), and which are designated to study, examine, or evaluate: a) service programs or public benefits; b) procedures for obtaining programs’ services or benefits; c) alternatives to the program or procedure or potential modifications in; or d) the possibility of changing the methods or levels of payment for services or benefits in these programs.

•Category 6

Evaluation of taste and food quality and consumer acceptance studies.

LEARN MORE:  

If you’re interested in learning more about this topic, we recommend you to also take a look at the following questions:

•What is the institutional review board (IRB) charged with?

•The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as?

KEYWORDS: Federal Regulations, Exempt Categories

Subject  : Social Studies

Class  : 10-12

Sub-Chapter: Exemption on Conducting Research

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