Tutorial Chapter 8: What are the categories of application?

Case Study:

An investigator in the School of Education at the University is interested in whether the level of learning attained by high school students in the New York City school system differs significantly depending on the way in which they are being taught.

She finds that there are two schools in one of the boroughs teaching the same curricula but in very different ways. In one school, students are expected to work to a very rigid syllabus and teachers are given very little leeway in their approach to the topics. In the other school, the same syllabus is being taught in a more participatory environment. Teachers are given general guidelines and specific learning objectives but no detailed instruction in how to teach the topic. In fact, they are encouraged to try innovative ways to engage the students.

The investigator would like to observe the two sets of teachers at work and then to draw conclusions about the impact of the different approaches to the curriculum on the students' level of learning.

What course should the investigator follow?

  • A: Since students will not be interviewed (although their teachers may be), the researcher decides to request Exempt status for her work in her Application for Review. As she understands the regulations governing human subjects, the study of normal educational practices in commonly accepted educational settings is one of the categories of application that qualify for Exempt status.
  • B: The investigator determines that her study falls into an Exempt category because the students are being observed only in the course of normal classroom activities and will have no interaction with the investigator and the interviews with teachers will be on non-sensitive topics with adults. Therefore, she does not apply to the UCAIHS for approval.

Investigators may apply to the University Committee on Activities Involving Human Subjects (UCAIHS) for Exempt status if their research falls within certain categories of research considered very low risk under Federal regulation.

The designation of Approved as Exempt may only be made by the UCAIHS, not by the investigator. A full application must be submitted for an announced deadline in order for the Committee to determine whether a project should be granted Exempt status.

If granted Exempt status, a project will no longer be under UCAIHS oversight as long as no changes are made to the protocol as Approved as Exempt. If changes are planned, those changes must be submitted to the UCAIHS for review and approval prior to being initiated.

Exempt Research Categories

Categories of research which are exempt include:

  • The study of normal educational practices in commonly accepted educational settings. This includes research of:
    • regular and special education instructional strategies;
    • the effectiveness of or the comparison of instructional techniques, curricula or classroom management methods.
    Note: The fact that the research takes place in the school does not necessarily mean that Exempt status is appropriate. Activities introduced for the purpose of a study do not constitute normal educational practice.
  • The use of educational tests, surveys, interviews, or observation of public behavior where:
    • identifiers are not recorded by the PI; or
    • there is neither a risk of harm to subjects nor information sought concerning sensitive aspects of the subject's behavior (this does not apply to research involving surveys and interviews with children); or
    • there is neither a risk of harm to subjects nor observation of sensitive aspects of the subject's behavior (this does not apply to research with children when the investigator(s) participate in the activities being observed); or
    • subjects are public officals or candidates for public office; or
    • Federal statute(s) require(s) without exception that confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
  • The collection or study of existing data (all work with subjects have been completed), documents, records, pathological or diagnostic specimens, where publicly available or where the information is private but identifiers are not recorded by the PI.
  • Taste and food quality evaluation and consumer acceptance studies if:
    • wholesome foods without additives are consumed; or
    • a food is consumed that contains a food ingredient at or below the level found to be safe for use by the Food and Drug Administration (FDA) or the Food Safety and Inspection Service of the US Department of Agriculture; or
    • a food contains an agricultural chemical or environmental contaminant at or below the level found to be safe for use.

Note: Research (except some projects using existing data) is not eligible for Exempt status if it involves:

  • minors (under 18 years of age) except in cases of studies of normal educational practice or collection/study of existing data
  • prisoners
  • fetuses
  • institutionalized mentally disabled people.

Chapter Review

Question 1

Designation of Exempt status is made by:

  • the researcher
  • the UCAIHS
  • the Dean
  • the Federal government.

Question 2

If research takes place in an educational setting, it is exempt.

Question 3

The study of all previously collected data is exempt.

Question 4

Research with minors involving observation in a school setting cannot be granted Exempt status when investigator(s) participate in the activities being observed.

Question 5

Which of the following groups of subjects may be studied with Exempt status?

  • prisoners
  • institutionalized mentally disabled people
  • fetuses
  • none of the above

Next Chapter: What information must investigators give to the UCAIHS?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Glossary
  • References