Committee For the Protection of Human Subjects

Exempt from IRB Review

POLICY

It is the policy of UT Houston 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 to be made by the CPHS office.

(Note: These categories do not apply to research involving prisoners. Category 1 – 5 do not apply to FDA regulated research.)

 

Exemption Category 1 – Normal Educational Practices and Settings - Research conducted in established or commonly accepted educational settings, involving normal educations practices, such as:

§  Research on regular and special education instructional strategies; or

§  Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

 

Exemption Category 2 - Anonymous Educational Tests, Surveys, Interviews, or Observations – Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior, unless:

§  Information obtained in recorded in such a manner that human subjects can be identified, directly or indirectly through identifiers linked to the subjects; and

§  Any disclosure of the human subjects’ responses outside of the research could reasonably place subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

The exemption under Category 2 DOES NOT APPLY to research involving survey or interview procedures or observation of public behavior when individuals under the age of 18 are subjects of the activity except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

 

Exemption Category 3 – Identifiable Subjects in Special Circumstances - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Exemption Category 2, if:

§  the human subjects are elected or appointed public officials or candidates for public office; or

§  statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 

Exemption Category 4 – Collection of Existing Data - Research involving collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 

§  To qualify for this exemption, data, documents, records, or specimen must have been collected before the research project begins.

§  Under this exemption, an investigator (with proper HIPPA Waiver or Alteration authorization) may inspect private, identifiable records, but may only record information in a non-identifiable manner. 

§  The data must be permanently and completely de-linked at the time of extraction.  A code may be used to organize data as it is collected.  However the code may not be a means of re-linking the data set to the original data source.

 

Exemption Category 5 – Public Benefit or Service Programs - Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

§  Public benefit or service programs;

§  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.

 

The following criteria must be satisfied to invoke the exemption for research and demonstration projects examining “public benefit or service programs as specified in Department of Health and Human Services regulations:

§  The research or demonstration project is conducted pursuant to specific federal statutory authority.

§  There is no statutory requirement for IRB review of the project.

§  The project does not involve significant physical invasions or intrusions upon the privacy of participants.

§  The program under study delivers public benefit or service.

§  This exemption is for projects conducted by or subject to approval of Federal agencies, and is most appropriately invoked with authorization or concurrence by the funding agency.

 

Exemption Category 6 – Taste and Food Evaluation and Acceptance Studies - 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.

 

PROCEDURE

Submission of Request for Exemption

The Principal Investigator may make a preliminary determination that the protocol may qualify for exemption based on the ‘Screening Questions for Exempt Research’ on the iRIS application form and submit to CPHS for review and approval. The Principal Investigator should justify the reasons for the determination and submit the study protocol and any additional information including survey forms, consent forms, etc. The Principal Investigator must also submit information regarding access to protected health information by completing the relevant HIPAA forms.

Investigators do not have the authority to make an independent determination that research involving human participants is exempt and must contact the CPHS if there are any changes to the research.

 

Assigning for Review

The ORSC Staff assigns an IRB tracking number to the submission and reviews the submission to ensure that the information provided is complete. If the submission if not complete, the ORSC staff returns the submission to the Principal Investigator for additional information.

The ORSC Staff forwards the complete application to the ORSC Director or designee for review and approval. The Executive Committee has given authority to determine exemption status to the ORSC Director.

 

Review of Exempt Proposals

The ORSC Director reviews the application and determines if the protocol qualifies for exemption as listed in Item 3 of this policy and procedure.  The ORSC Director will also evaluate if:

§  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.

§  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 or 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 ORSC Director will consult with the IRB Chair. If still in doubt, the protocol is assigned for expedited or full board review. If the ORSC Director is not available to review exemption requests, the ORSC Assistant Director is responsible for the review of exemption requests.

 

Possible Outcomes of Review

Request for Exemption Approved - If the ORSC 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 ORSC Director will send a notification to the Principal Investigator via the iRIS system.

§  Request for Exemption Not approved - If the ORSC Director determines that the proposed research plan does not meet the criteria for exemption or does not protect human subjects adequately, the ORSC Director will return the submission back to the Principal Investigator to complete the iRIS application for expedited or Full Board review.

 

APPLICABLE REGULATIONS

1.       45 CFR 46.102

2.       21 CFR 50.3

3.       38 CFR 16

4.       UTHSC-H HOOP (specific link)

RELEVANT AAHRPP ELEMENTS

1.       I.3.D

2.       I.3.E

3.       II.3.A

REFERENCE TO OTHER POLICIES

1.       None.

RELATED DOCUMENTATION IN iRIS APPLICATION.

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

 

Document Number:

101-C02

Document Name:

Exemptions

Approved by:

ORSC Director

Effective:

1 Jan 2009

Revision History:

1 Aug 2011

 

 

 


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
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Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713.500.7943
Fax     713.500.7951
Email cphs@uth.tmc.edu 

IRIS Support 713.500.7960

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