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Exempt Research: Human Subjects

Excerpted from the CUHS Template Guide:

A large proportion of the initial applications to CUHS receive an exemption determination, mostly categories 1 and 2 (see below for a description of the categories).

Application process for potentially exempt research

There are two important differences in the requirements for exempt research:

1. For student research, a Faculty Sponsor is still required, but the Faculty Sponsor is not required to take ethics training.

2. The consenting process must meet only an abbreviated set of requirements.

If you think that your research qualifies for an exemption, you should read the criteria listed below carefully (and please contact CUHS if you have questions about whether your project fits the definitions), and fill out and submit the CUHS Protocol Template through ESTR, using the following specific directions:

1. Exempt guidance for question 2.1, Provide a thorough description of all study procedures: describe how your procedures fit into the applicable exemption category. In particular, for exemption category 2, explain why you are not collecting data that is both identifiable and damaging if revealed. Describe the information that will be collected and attach your survey, interview guide, etc. to the “Supporting Document” page of the SmartForm.

2. Exempt guidance for question 7.1, Will participants be asked to agree to be in the study?:

  • If you are interacting with participants, you must obtain their consent; however, you are not required to provide a consent form that subjects will sign. Instead, you should attach an information sheet or oral script that contains the following four elements: (1) a description of the procedures (interview, survey, etc.): what questions will be asked, how long it will take, whether the information will be confidential, etc.; (2) a statement that the activities involve research; (3) a statement that participation is voluntary; and (4) your name and contact information. The CUHS website has sample exempt information sheets. Please note that if our review finds that the research does not qualify as exempt, we will contact you to prepare and submit a full consent form, which will lengthen the review process.

  • If you are not interacting with subjects (e.g., category 2 observations of public behavior, category 4 use of existing data), say that you are not obtaining consent.

3. Exempt guidance for question 8, Risks. If there are any reasonably foreseeable risks, such as any risk from a breach of confidentiality, your research is not exempt. You may describe discomforts, such as not wanting to answer a question or becoming tired, and measures you are taking to minimize discomforts such as emphasizing that any question can be skipped and the participant can stop at any time.

4. Exempt guidance for question 9, Data Confidentiality. If you believe your research qualifies for an exemption determination in category 2, the information security level must be 1 or 2.

5. Please note: Certain answers preclude exemption, specifically studying prisoners (question 6) or interacting with children (question 6).

Common exemption categories

The full list of categories can be found at 45 CFR part 46.101(b):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices. (Both the procedures involve normal education practices and the objectives of the research involve normal educational practices.)

Note: To qualify as category 1, you must be investigating an educational practice that has already been used and studying it in an educational setting, from pre-school through graduate school and adult education.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that Human Subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the Human Subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. If the research involves children, the procedures are limited to (1) the observation of public behavior when the investigator(s) do not participate in the activities being observed and (2) the use of educational tests.

Note: For a survey or interview to qualify as category 2, if must either ask no questions where the answers could be damaging, or, if it does, you must be recording the answers without identifiers, for example, by taking notes that do not include the participant’s name or other identifiers, or by using an online system such as Qualtrics that prevents you from linking the name or IP address of the participant with his or her responses.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Note: Research qualifies for category 4 if the existing data contains identifiers (if it doesn’t, then the project is not human subjects research), and if you are seeing the identifiers but not recording them (if you are recording identifiers, then this exempt category does not apply).

Obligations of Principal Investigators of Exempt Research

The determination that your research is exempt does not expire, and you will not file annual renewals. Changes to the research may be made without notification or pre-review by CUHS, unless the changes are such that the research might no longer meet the exemption criteria. Examples of changes that you should not make unless they have been submitted and reviewed by CUHS include:

• You planned to interview adults only, but now you want to interview minors

• You planned to survey people online, but now you want to include experimental manipulations

• You planned to test students on a new math curriculum, but now you want to text them encouraging messages before class exams

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