NEW “CATCH-ALL” EXEMPT CATEGORY 13

May 2018 Issue

Authors:

• Matthew Ogrodnik, MS, CIP, IRB Administrator

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• INTRODUCTION
• WHAT IS “EXEMPT” HUMAN SUBJECTS RESEARCH, AND WHAT DOES IT MEAN?
• WHAT TYPE OF RESEARCH QUALIFIES FOR THIS NEW CATEGORY?
• IS A CONSENT FORM REQUIRED?
• WHAT DO I HAVE TO DO AFTER MY PROJECT HAS BEEN DETERMINED TO BE EXEMPT UNDER THIS CATEGORY?
• SUMMARY

INTRODUCTION

Based on the HRPP Advisory Committee recommendations, the Institutional Officials and the Boston Medical Center/BU Medical Campus IRB recently approved the use of a new exempt human subjects research category:

(13) Minimal risk research without external funding with adult subjects able to provide abbreviated consent where the research does not qualify for categories (7) through (12).  

WHAT IS “EXEMPT” HUMAN SUBJECTS RESEARCH, AND WHAT DOES IT MEAN?

Briefly, 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. 

Note:  Please see the following feature article for a detailed description of exempt human subjects research: April 2017 CR Times Feature Article

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
• Not involve prisoners as subjects; and
• Fit into a defined Exempt category:
• One of the six exempt categories defined by the Common Rule (Code of Federal Regulations Title 45 Part 46 – abbreviated 45 CFR 46); or
• One of the seven additional exempt categories defined locally with our “Equivalent Protections” policies for research without external funding. This new exempt category is within this group of equivalent protections categories.

WHAT TYPE OF RESEARCH QUALIFIES FOR THIS NEW CATEGORY?

Boston Medical Center and Boston University Medical Campus have established local protections that differ from the Common Rule. These “Equivalent Protections” include exempt categories that are specific to this institution. This new exempt category fits into this group. Thus, in order for a study to qualify as exempt research under this new category, it must be eligible for equivalent protections.

Studies that are *not* eligible for equivalent protections are:

• Studies with federal funding (including support for any researchers under a federal training grant)
• Clinical investigations involving products regulated by the FDA; and
• Studies where the sponsor or funder of the research requires adherence to the Common Rule; 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 new exempt category.

This new exempt category is intended to be used for minimal risk research that does not fit into the other six equivalent protection exempt categories. A wide variety of minimal risk research can qualify for this category; but not research that includes children, prisoners, or adults with diminished decision-making capacity. Note that such research can still be done; it just requires approval rather than exemption from the IRB.

The full list of the Equivalent Protections exempt categories is as follows:

The Seven “Equivalent Protections” Exempt Categories

(7)   Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or (B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (C) The IRB determines that confidentiality procedures will be adequate to protect information obtained that is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects. For the purpose of this category, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

(8)   Research with children (with child assent and parental permission) involving surveys, interviews, and/or observation of public behavior where the investigator participates in the activities being observed.

(9)   Research involving identifiable data or specimens that have been or will be collected for non-research purposes.

(10) Research involving data 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:

1. All patients who get an intervention are expected to benefit; and
2. All measurements that are collected are to determine the effect of the process change; and
3. All patients involved in the intervention receive standard care at a minimum; and
4. The intervention meets evidence-based or consensus-based quality standards; and
5. Confidentiality protections are appropriate to the sensitivity of the data collected; and
6. 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.

(12) Research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) where the IRB determines that the confidentiality procedures are adequate to protect information that is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.

NEW: (13) Minimal risk research without external funding with adult subjects able to provide abbreviated consent where the research does not qualify for categories 7 through 12.
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The majority of studies that will qualify for category 13 will involve an intervention and/or a research method(s) that goes beyond surveys, interviews, and/focus groups; and further, an intervention that does not otherwise meet the definition of a benign behavioral intervention (as described in category 7 above).  For example, a study examining the effect of a text messaging system on appointment adherence might qualify for category 13; or, a study using the photovoice method in which participants are asked to take photographs of issues of importance to them, and then discuss them with the researcher.

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 does not apply to exempt research, our local Policies and Procedures require that there still be a consent process in any exempt human subject research that involves direct interaction with subjects. In order to be eligible for exemption under this new category, therefore, this 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.

WHAT DO I HAVE TO DO AFTER MY PROJECT HAS BEEN DETERMINED TO BE EXEMPT UNDER THIS CATEGORY?

These requirements apply to projects given an exempt determination under any category. If you make changes to your project that may affect the exempt determination, then you will need to submit an amendment through INSPIR.  Minor changes, such as changes to wording on a questionnaire, do not require submission of an amendment.  If, however, you are changing the types of questions you are asking (such as more sensitive questions that are not anonymous), or adding a new type of intervention and/or procedure, then you are required to submit an amendment.  Exempt determinations expire after three years. You will receive a request to either close or renew three years after the exempt determination. The renewal application includes a question about the status of the study; and a request to detail the changes, if any, that have been made to the study since the time of initial review by the IRB.

SUMMARY

The INSPIR system has been updated to add a new category 13 for exempt human subjects research. Most minimal risk research without external funding that involves adults who are able to provide abbreviated consent will qualify for this new exempt category. This category will encompass 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.