According to the federal regulations, research is eligible for the 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 eight categories of research activity described in the regulations.
The correct answer is D. The research falls into one of eight categories of research activity described in the regulations.
The Institutional Review Board (IRB) review the exempt research initially. The exempt research will meet the specified federal criterion and fall in one of the eight different categories. IRB is a body that works for the welfare of human research subjects who incorporates in research activities. IRB protects the legal right of the participants in a research study.
The IRB qualified staff take the responsibility of reviewing all the researches which involve human subjects. They ensure the moral principles (the respect for persons, beneficence and justice are complied with).
Why option A, B and C are incorrect:
As we have discussed above, the essential criteria for the research to be exempt is, it should fall into one of the eight categories; therefore, these options (All the subjects are adults or not, the investigator is experienced or not and its takes more or less than 10 minuts of participants) does not matter.
Therefore, research activities that incorporate human subjects and may fall into one of the categories below are exempted from the research review.
The Categories for exemption includes:
- Educational practices, settings
- Educational tests, interviews, observations, surveys
- Educational rests, observations, surveys, and interviews of public officials
- Existing data, records, documents, specimens
- Service programs or public benefit
If a research does not meet the requirements defined for research with human subjects, it is directly excluded from the IRB review.
All human subjects’ research conducted by an organization must receive approval from IRB. IRB reviews all completed protocols for an exemption or go under expedited review, as received.