Exemptions

POLICY

It is the policy of UTHealth that research activities, in which the only involvement of human subjects is in one or more of the specific categories as listed below, may qualify for exemption. Exemption determinations are made by the IRB office.

These exemption determinations may be applied to research involving pregnant women and children (with exceptions for category 2 research). The exemptions do not apply to research involving prisoners, unless the research is aimed at a broader population and only incidentally includes prisoners.

Exemption Category 1 – Normal Educational Practices and Settings - Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or 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 Category 2 - Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior (including visual or auditory recording), if at least one of the following criteria is met:

1. Information obtained is recorded in such a manner that the identity of the human subjects cannot be readily ascertained, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects’ responses outside of the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation; or
3. 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.

Exemption determinations may be applied to research involving children only apply to research involving educational tests or observation of public behavior when the researchers do not participate in the activities being observed. This exemption does not apply to research involving children when information is identifiable.

Exemption Category 3 – 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:

1. 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;
2. 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
3. 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.

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.

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.

Exemption Category 4 – 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 publically 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 regulations, for the purposes of “health care operations” or “research” or for “public health activities and purposes”; or
4. Under this exemption, an investigator (with proper HIPAA Waiver or Alteration authorization) may inspect private, identifiable records, but may only record information in a non-identifiable manner.

Exemption Category 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 (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), 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. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants.

Exemption Category 6 –Taste and food quality evaluation and consumer acceptance studies,

• if wholesome foods without additives are consumed; or
• if a food is consumed that contains a food ingredient 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.

Exemption Category 7 - Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review.

Exemption Category 8 - Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained;
2. Documentation of informed consent or waiver of documentation of consent was obtained;
3. An IRB conducts a limited IRB review and makes the determination that the research to be conducted is within the scope of the broad consent; and
4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

PROCEDURE

Requests for exemption determinations are to be made via the iRIS application system.

Review of Exempt Proposals – The IRB director or designee reviews the application and determines if the protocol qualifies for exemption. The IRB director and the designee are also IRB voting members.  The IRB director or designee will evaluate whether:

• The proposed research plan adequately protects the human subjects and whether additional protections are needed.
• The proposed research holds no more than minimal risk to subjects.
• If applicable, selection of subjects is equitable.
• If identifiable information is being recorded, there are adequate provisions to protect confidentiality.
• There are adequate provisions to protect privacy interests of subjects.
• If there are interactions with subjects, there will be a consent process that will disclose information about the research such as, the activity involves research, a description of the procedure, that participation is voluntary and the name and contact information for the investigator.
• When it is not clear whether a protocol qualifies for exemption, the protocol is assigned for expedited or full board review.

For purposes of conducting the limited IRB review required for exemption category 2 and 3, the IRB director or designee shall review the research to ensure there are adequate provisions to protect privacy of the participant and confidentiality of the data. Some considerations:

• Extent to which identifiable private information is or has been de-identified and the risk that such de-identified information can be re-identified
• Use of the information
• Extent to which the information will be shared or transferred to a third party or otherwise disclosed or released
• Likely retention period or life of the information
• Security controls that are in place to protect the confidentiality and integrity of the information
• Potential risk of harm to individuals should the information be lost, stolen, compromised, or otherwise used in a way contrary to the contours of the research under the exemption.

For purposes of conducting the limited IRB review required for exemption category 7, the IRB director or designee shall make the following determinations:

• Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained;
• Broad consent is appropriately documented or waiver of documentation is appropriate; and
• If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Possible Outcomes of Review

Request for Exemption Approved - If the IRB director or designee determines that the proposed research plan meets one of the exemption criteria and adequately protects human subjects, the request for exemption will be approved. The IRB Director will send a notification to the Principal Investigator via the iRIS system.

Request for Exemption Not approved - If the IRB director or designee determines that the proposed research plan does not meet the criteria for exemption or does not protect human subjects adequately, the study will be reviewed under an applicable expedited category or by full board review.

APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 56 Institutional Review Board
3. OHRP FAQ – Exempt Research Determination

REFERENCE TO OTHER POLICIES

1. Initial Review 

ATTACHMENTS

1. IRB Application Form
2. Authorization for Disclosure of PHI
3. Memorial Hermann Research Application

If you find errors in this document, contact cphs@uth.tmc.edu

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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