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Categories of Research and Levels of Review

EXEMPT

Certain types of human subjects research may be considered exempt from the HHS regulations. It is up to the REC to determine whether or not proposed research qualifies as exempt. Below is an overview of the types of research that may be exempt. Please refer to the decision charts button to help you determine whether or not your research qualifies for exemption. If you still need more information, the OHRP website contains a full list of exemptions, including associated criteria

Even if your research qualifies as exempt, you must still submit your proposal to the REC for determination and approval of exempt status prior to initiating your research.

Categories of Exemption:

Note, these exemptions may not apply to certain vulnerable populations such as children and prisoners, please see the OHRP website linked above for more information. 

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices.
  2. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, EXCEPT when participants can be identified and such disclosure results in risk.
  3. Research involving benign behavioral interventions (i.e., brief in duration, harmless, painless, not physically invasive, no significant adverse lasting impact, and not offensive or embarrassing to participant) in combination with the collection of information, EXCEPT when participants can be identified and such disclosure results in risk.
  4. Secondary research for which consent is not required (e.g., participants identity cannot be readily ascertained, identifiable information is publicaly available, identifiable information was originally collected for non-research purposes, or collection and analysis of identifiable information are for the purposes of “health care operations,” “research,” or “public health activities and purposes).
  5. Research and demonstration projects conducted or supported by a federal department or agency that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs.
  6. Taste and food quality evaluation of consumer acceptance studies.
  7. Storage or maintenance for secondary research for which broad consent is required.
  8. Secondary research for which broad consent is required.

-----------EXPEDITED----------------------------FULL BOARD------------

  • Research activities that present no more than minimal risk to human subjects and involve only procedures listed in one or more of the following categories may be eligible for expedited review:

1. Certain drug and device studies.

2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture under certain conditions.

3. Collection of biological specimens for research purposes by noninvasive means (e.g. saliva, hair and nail clippings, etc.)

4. Collection of data through noninvasive procedures routinely employed in clinical practice (e.g. EEG, MRI, sensors, etc.)

5. Materials / data collected solely for non-research purposes (i.e. secondary use / records review)

6. Voice, video, digital, or image recordings made for research purposes

7. Research on individual or group characteristics or behavior or research utilizing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

8-9. Certain continuing reviews

Click here to see the full description of expedited categories on OHRP’s website.

  • Approval can be given by REC reviewers without a convened meeting
  • No continuing review is required
  • Research that involves greater than minimal risk or is not eligible for expedited review.
  • Minors if data are sensitive
  • Vulnerable populations (prisoners, individuals with impaired decision making abilities, pregnant women, fetuses, newborns)
    • Note that inclusion of prisoners as research participants may require additional documentation:
      • You may need to obtain a CoC if there is potential for disclosure of sensitive or incriminating information. Please read this document on CoC requests BEFORE making the request. Click here to find more information about a CoC on the NIH website and navigate to request a CoC. Note that research investigators are not the IO to be listed on this document. If you have any questions about the details of the CoC request please email rec@spalding.edu before submitting the request to be sure the proper information is submitted. 
      • In your proposal, or as a separate attachment, you will need to included answers to the 7 additional required elements of research involving prisoners at 45CFR46.305. Those considerations can be found here, along with additional information regarding research with prisoners. 
  • Increased physical discomfort, risk of injury or invasion of privacy
  • Use of procedures that are considered intrusive, stressful, or potentially traumatic.
  • Involvement of intentional deception, such that misleading or untruthful information will be provided to participants.
  • Requires a quorum of REC members present at convened meeting with a majority voting to approve
Click here for a downloadable file noting the different categories of exempt, expedited or full board review levels.

Records Based Research

  • Records based research (formerly archival data) is research that proposes to utilize data that was or is being obtained for purposes other than the current research (e.g. reviewing previously collected data that was obtained with broad consent or reviewing clinical or other types of records that are collected for non-research purposes).
  • The investigator(s) will not have any form of interaction with the participants other than obtaining consent to use their existing data (if applicable).
  • May not involve all of the required elements as a standard proposal.
    • Note: If you are only doing records review, this is the only form you need to submit. However, if you are doing records review as just one part of a larger project that involves other components, you will need to submit the main research proposal form as well as this records based proposal form. The records review proposal ID should be referenced in the primary research proposal submission.
  • Requires permission from the investigator, agency or institution providing access to the records / database
  • The following are links to documents that may be helpful in understanding how protected health information may be handled for research purposes:

Submit Records Based Research Proposal Here

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