Opportunity for Exemption: Minimal Risk Research with Adults

April 2025 Issue

Author(s):

  • Matt Ogrodnik, MS, CIP, OHRA Director

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Introduction

Human subjects research is termed “Exempt” when it DOES constitute research with human subjects, but ALSO meets the requirements of a defined low-risk category that is exempt from SOME (but not all) of the requirements governing human subjects research. 

In brief, to qualify as exempt, the research must:

  • NOT be a clinical investigation of a product regulated by the Food and Drug Administration; and
  • Pose no greater than minimal risk to the subjects; and
  • Fit into a defined Exempt category:
    • One of the eight exempt categories defined by the “Common Rule” (Code of Federal Regulations Title 45 Part 46); or
    • One of the five additional exempt categories defined locally with our “Equivalent Protections” policies for research without external funding.

This CR TIMES Feature Article focuses on one of our five local “Equivalent Protections” exemption categories; namely, exemption category 13:

“(13) Minimal risk research without external funding with adult subjects able to provide abbreviated consent where the research does not qualify for categories (9) through (12)”

This is a very flexible exempt category and, therefore, it is important to know when your study qualifies. Understanding whether your planned research project fits into this exemption category will enable you to adequately plan for considerations such as selecting the correct IRB application review path, using the appropriate “abbreviated consent” template, and determining when verbal consent is sufficient.

Note:  Please see the following feature article for a detailed description of all types of exempt human subjects research: March 2019 CR Times Feature Article.

 

What Type Of Research Qualifies For This Category?

Boston Medical Center (BMC) and Boston University (BU) Medical Campus have established local protections that differ from the Common Rule. These “Equivalent Protections” include exempt categories that are specific to this institution. Exempt category 13 fits into this group. Thus, in order for a study to qualify as exempt research under this category 13, it must be eligible for equivalent protections.
Studies that are *not* eligible for equivalent protections are:

  • Studies with external funding (including support for any researchers under a federal training grant);
  • Clinical investigations involving products regulated by the FDA;
  • Studies where the Boston Medical Center / Boston University Medical Campus IRB is serving as the IRB of record for an external site, unless specifically permitted by the relying institution; and
  • Studies that have utilized or will utilize any clinical services

If a research study does not fall into one of these groups, then it will be eligible for equivalent protections, and may, therefore, be eligible for this exempt category 13.

This exempt category is intended to be used for minimal risk research that does not fit into the other four equivalent protection exempt categories. Therefore, to understand category 13, it is helpful to be familiar with all “Equivalent Protections” Exempt categories:

The Five “Equivalent Protections” Exempt Categories

(9) Research involving the study of materials (data, documents, records, or specimens) that have been or will be collected solely for non-research purposes (as discussed in the CR TIMES Feature Article: "Chart Review" Submissions and the IRB: Step-by-Step Instructions - June 2024)

(10) Research involving the study of materials (data, documents, records, or specimens) that have been collected for research purposes when the consent for the research does not preclude such additional research.

(11) Research involving Quality Improvement/Quality Assurance where:

  • All patients who get an intervention are expected to benefit; and
  • All measurements that are collected are to determine the effect of the process change; and
  • All patients involved in the intervention receive standard care at a minimum; and
  • The intervention meets evidence-based or consensus-based quality standards; and
  • Confidentiality protections are appropriate to the sensitivity of the data collected; and
  • Obtaining consent from the patients is not practicable because the change or intervention will be carried out in a clinical setting where there is no meaningful way for patients to opt out of receiving the intervention (as discussed in the CR TIMES Feature Article: Quality Improvement/Quality Assurance Projects - When Do They Require IRB Review? - Jun 2021)

(12) Research with children involving survey procedures, interview procedures, or observation of public behavior where the investigators or research staff participate in the activities being observed.

(13) Minimal risk research without external funding with adult subjects able to provide abbreviated consent where the research does not qualify for categories (9) through (12).

A wide variety of minimal risk research can qualify for category 13; but not research that includes children, prisoners, or adults with diminished decision-making capacity.

The majority of studies that will qualify for category 13 will involve an intervention and/or a research method(s) that goes beyond only employing surveys, interviews, and/focus groups (as these methods fit under federal exempt category 2 with adults, and “equivalent protections” category 12 with children); and further, involves an intervention that does not otherwise meet the definition of a benign behavioral intervention (as described in federal category 3).  

For example, the following types of research may qualify as exempt under category 13:

  • A study examining the effect of a text messaging system on appointment adherence; or
  • A study involving a research-only blood draw(s); or
  • A study involving minimal risk biological sample collection (for example, collection of saliva, cells from cheek or nasal swabs, or teeth extracted for clinical purposes); or
  • A study involving the collection of data through noninvasive procedures, such as exercise testing or research-only MRIs; or
  • A study involving one of the above, plus an associated identifiable medical record chart review

As this new exempt category 13 is designed to be a “catch-all” for minimal risk research, there will surely be many different types of research methods that qualify for this exempt category beyond those described above. Please always feel free to reach out to IRB at medirb@bu.edu to discuss whether your study may qualify as exempt human subjects research under this category 13.

 

Is A Consent Form Required?

Importantly, in order to qualify for exemption under this category, the research must involve adults who are able to provide abbreviated consent to participate in the study.

While the regulatory requirement for a consent form with all required elements does not apply to exempt research, our local HRPP Policies and Procedures require a consent process in any exempt human subject research that involves direct interaction with subjects. Therefore, in order to be eligible for exemption under this category, a consent process must take place. The elements that need to be covered in this process are:

  • that this is a research study; and
  • that participation is voluntary; and
  • the purpose; and
  • what the subjects are being asked to do; and
  • confidentiality protections; and
  • how long participation is expected to take; and
  • a disclosure if the subject will be audio- or video-taped; and
  • how to contact an investigator or research staff member for questions about the study.

Further, in order to qualify as exempt research in this category, there is another element of abbreviated consent that must be included; namely, if the research involves deceiving the subjects regarding the nature or purpose of the research, then the abbreviated consent must include that subjects will be unaware of or misled regarding the nature and purpose of the research, and subjects must be debriefed at the end of their participation.

The Exempt Information Sheet Template on the IRB website should be downloaded, customized for the study, and submitted with the IRB application.

If the study involves interaction with subjects, then the plans for conducting the consent process--along with either a script (if orally), a written sheet, or the questionnaire that includes this information--must be included in the IRB application.

 

Is Written Consent Signature Required?

If the study does not involve the collection of protected health information (PHI), then there is no requirement for a signature, and no requirement that the abbreviated consent information be delivered in writing. In these circumstances, the elements can be included as part of an online survey (prior to survey initiation), as a written sheet that is given to participants, or delivered orally.  If delivered orally, you should, as a courtesy, provide the subject with the PI’s name and contact information in a written format, so that they know how to contact the study team should any questions or issues arise.

However, if the study requires signed authorization for use and disclosure of PHI (if, for example, you are collecting information from subjects’ medical records for use during the study), then a signature may need to be obtained. In these instances, some form of the authorization language needs to be included in the abbreviated consent form. The “abbreviated consent” templates now provide the option of using an abbreviated version of the HIPAA Authorization language (“Use and Sharing of Your Health Information”). If you are not obtaining electronic or physical subject signatures when obtaining abbreviated consent, then you may delete the Full Version of the Use and Sharing of Your Health Information section; and, instead, use the Abbreviated version. The Full Version should still be used if you are obtaining electronic or physical signatures.

If you ever have any questions about whether abbreviated consent signature is needed for your study, please do not hesitate to contact the IRB at medirb@bu.edu.

 

What Do I Have To Do After My Project Has Been Determined To Be Exempt Under This Category?

If you make changes to your project that may affect the exempt determination, then you will need to submit an amendment through INSPIR prior to implementing the changes.  Minor changes, such as changes to wording on a questionnaire, do not require submission of an amendment.  If, however, you are making changes that may affect the exempt determination (such as adding new funding, modifying the request for a waiver of HIPAA authorization, or altering your confidentiality protections), then you are required to submit an amendment. The full list of changes that require an amendment are described in HRPP Policy Section 10.2.4.1.

Exempt determinations expire after three years. Our HRPP Policies and Procedures mandate that researchers submit a “Status Check-In” for exempt research no later than three years after initial approval is granted. For more information on the Status Check-In process, please review the CR TIMES Feature Article: Time for "Status Check-In": What is Required? - Mar 2024.

Lastly, when it is time to close your study, you may close your exempt study without needing to submit a Final/Closure Report by changing the study status to CLOSED in the electronic system INSPIR. Instructions for closing an exempt study are here:

Keep in mind that letting an exempt study lapse by failing to change the status to CLOSED prior to the status check-in date does not fulfill the requirement to close a study. The IRB will continue to check new submissions to determine whether the Principal Investigator is responsible for any lapsed exempt studies as the Principal Investigator or Supervising Principal Investigator. If so, the Principal Investigator will be informed that the new study will not be considered by the IRB until the lapsed exempt study has been closed.

 

Summary

Most minimal risk research without external funding that involves adults who are able to provide abbreviated consent qualifies for exempt category 13. This category encompasses a wide variety of research methods, so please feel free to reach out to the IRB if you have any questions about whether your project may qualify as exempt human subjects research under this category.