Exempt Review Types

Exempt Review Process

For specific kinds of low-risk human subjects research that have a specified exemption in 45 CFR 46.102 (before 1/19/19) and 45 CFR 46.104 (after 1/19/19). In order to qualify for exemption, a research study must fall entirely within one or more of the current categories for exemption, it cannot place subjects at greater than minimal risk and cannot use high risk subjects.  Exemption status does not excuse the research from meeting the ethical intent of the Belmont Report and Common Rule or from obtaining informed consent for research participation. If the research does not fit an exemption category, a expedited review application may still be made.

Limitations on Exemption: 

1. These exemptions do not apply to research involving prisoners except for research aimed at involving a broader subject population that only incidentally includes prisoners.
2. Exemptions only apply to GS researchers.  External collaborators will have to obtain exempt determinations based upon their institutional policy.
3. GS will has chosen to not implement Broad Consent so exemption 7 and 8 will not be supported.

See the following tabs for information on specific exemption categories.  

Category 1  (For forms – scroll to bottom of instructions – Reference citation 45 CFR 46.104 (d)(1))

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to:

1. adversely impact students’ opportunity to learn required educational content or
2. adversely impact the assessment of educators who provide instruction.

This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Exemption 1 video – Jaime Hernandez, OHRP  –  clip  – from OHRP “Overview of Changes to Exemptions in Revised Common Rule (Focusing on Exemption 1,2,3 and 5)”  Full 26 Minute version.

Category 2  (For forms – scroll to bottom of instructions – Reference citation 45 CFR 46.104 (d)(2))

Research that includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), Survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) without additional intervention if at least one of the following criteria are met:

1. Information obtained is recorded in such a manner that human participants cannot be identified directly or through identifiers linked to them. Please visit our FAQ’s for more information on anonymous survey platforms.
2. Any disclosure of the human participant’s responses outside the research could not reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing, employ-ability or reputation, or
3. The information is obtained and recorded by the investigator in such a manner that the identify of the human subjects can be readily ascertained directly or through identifiers linked to the subject but the researcher provides adequate means to protect participant privacy and confidentiality and the IRB concurs.

AND

1. Survey or interview research does not involve children.
2. The research project does not include any form of intervention

Category 2 exemption does not apply to children, except in research involving observations of public behavior when the researcher(s) do not participate in the activities being observed. Interviews, surveys, and interactive observations are not exempt, while educational tests and non-interactive observations may access the exemption category 2.

Limited review is based on adequate provisions to protect privacy of subjects and to maintain the confidentiality of the data, based on the latest DHHS (Department of Health and Human Services) and local policies. Data Security Review will likely be required.

Exemption 2 video (approx 4 min)– Jaime Hernandez, OHRP  –  clip  – from OHRP “Overview of Changes to Exemptions in Revised Common Rule (Focusing on Exemption 1,2,3 and 5)”  Full 26 Minute version.

Category 3  (For forms – scroll to bottom of instructions – Reference citation 45 CFR 46.104 (d)(3))

i)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;
(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 information obtained 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, and an IRB conducts a limited IRB review to make a determination of exemption

(ii) For the purpose of this provision, 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.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

AND ALL of the following are met:

1. Data collection must only be through verbal, written or data entry responses by the subject or observation of the subject (including videotaping)
2. No children
3. No adults who require surrogate decision-makers
4. No medical-interventions (behavioral only)
5. Unlikely to offend or embarrass the subjects
6. Subjects agree in advance to participate (including passive deception)
7. Interventions are
   1. Brief in duration (with in a single day and not exceed a few hours)
   2. Painless and harmless
   3. Not physically invasive (including data sensors or devices)
   4. Not likely to have a significant adverse lasting impact on subjects

Examples and Definitions of benign intervention studies (from DHHS)

Limited review is based on adequate provisions to protect privacy of subjects and to maintain the confidentiality of the data, based on the latest DHHS (Department of Health and Human Services) and local policies. Data Security Review will likely be required.

Category 4 (For forms – scroll to bottom of instructions – Reference citation 45 CFR 46.104 (d)(4))

Reuse of secondary research for which consent is not required:

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

1. The identifiable private information or identifiable biospecimens are publicly available;
2. Information, which may include information about biospecimens, 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, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
3. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under (HIPAA) 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 512(b); or
4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

NOTICE:  If a Data Use Agreement or other document that includes terms of use or security is required you must apply for the exemption AND provide a blank (unsigned) copy of the agreement even if you believe your data does not require the specified protections.  If there is a separate data security instruction/agreement you must include a blank copy of that text as well.  If an online application containing terms or conditions is required, provide a blank printout displaying the terms.

Limited review is based on adequate provisions to protect privacy of subjects and to maintain the confidentiality of the data, based on the latest DHHS (Department of Health and Human Services) and local policies. Data Security Review will likely be required.

Category 5  (For forms – scroll to bottom of instructions – Reference citation 45 CFR 46.104 (d)(5))

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

To be eligible for this exemption the research or demonstration project must be published on the agencies publicly accessible federal website list prior to commencing the research involving human subjects.

Limited review is based on adequate provisions to protect privacy of subjects and to maintain the confidentiality of the data, based on the latest DHHS (Department of Health and Human Services) and local policies. Data Security Review will likely be required.

Category 6   (For forms – scroll to bottom of instructions –  Reference citation 45 CFR 46.104 (d)(6) and FDA reference 21 CFR 56.104 (d))

Taste and food-quality evaluation and consumer acceptance studies IF

1. wholesome foods without additives are consumed OR
2. a food is consumed that contains food ingredients at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA (Food and Drug Administration) or approved by the EPA (Environmental Protection Agency) or Food Safety and Inspection Service of the USDA (Agriculture).

Research Methods Class Exemption  (For forms – scroll to bottom of instructions )

Practice research involving human participants, as part of a class project assignment, can receive an exempt status determination. To be eligible the instructor must certify that, the projects poses no more than minimal risk to the participants, do not involve minors or vulnerable populations, do not involve deception or videotaping, do not collect data about illegal activity, sensitive private information or be potentially embarrassing to the subject and will not be presented or disseminated outside of the class.