FAQ's
- Do I need to apply to the IRB?
- What is considered a "human subject"?
- What is considered "research"?
- Where do I submit my protocol package?
- Why should a human subjects protocol be submitted by the researcher?
- What should be included in a human subject protocol package?
- Who can answer questions about the protocol?
- When are the IRB meetings?
- How long will the review process take?
- What is the process for notification of protocol status?
- Who are the IRB members?
- What about research involving the Clark County School District?
- How is the level of review for my protocol determined?
- Does a Pilot Study have to be reviewed by the IRB?
- If I am using a pre-existing data set with or without identifiers, do I have to get IRB approval?
- If I am doing research on samples obtained form cadavers, do I have to get IRB review?
1. Do I need to apply to the IRB?
Yes if you are:
1. Using human subjects.
2. Conducting research.
3. A UNLV Principal Investigator (PI).
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2. What is considered a "human subject"?
A "human subject" is defined as a living person about or from whom a researcher obtains (1) data through intervention or interaction with the person; or (2) identifiable private information about the person.
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3. What is considered "research"?
"Research" is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Other important definitions can be found in Code of Federal Regulations.
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4. Where do I submit my protocol package?
Protocols may be submitted to the Office for the Protection of Research Subjects, located in FDH (M/S 1047).
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5. Why should a human subjects protocol be submitted by the researcher?
UNLV is guided by the ethical principles regarding research involving human subjects as described in the Belmont Report. The Belmont Report is a report written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The Belmont Report set forth the criteria used by the U.S. Department of Health and Human Services (DHHS) to establish rules for institutions engaging in research. These rules were codified as 45 CFR 46 and in 1991 a common rule was established, which was adopted by all federal agencies. UNLV has filed an assurance with DHHS called the Federalwide Assurance to comply with these regulations. The federal agency under DHHS with oversight over human subjects research regulations is the Office of Human Research Protections. Also, please see UNLV Human Subjects Policy (doc) .
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6. What should be included in a human subject protocol package?
Protocols should include the following:
1) Research Proposal Protocol Form – complete all applicable sections. Students must have their Faculty Advisor listed as the PI.
2) The Informed Consent Form should include all the Basic Elements of Informed Consent, which is information that must be communicated to research subjects before they participate. The Informed Consent Template can assist you in creating the Informed Consent Form. For research involving venipuncture, see the Blood Draw Consent sample.
3) A copy of the instrument(s) used in the project, such as survey/interview questions or a flyer used to recruit subjects, should be attached.
4) All protocols must be accompanied by the CITI Training Certificate/s. The Faculty Advisor, Co-investigator/s, Students/Fellow and Research Team members working on the project must also submit the proof of CITI education certificate. OPRS will not accept protocols without the completion certificate.
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7. Who can answer questions about the protocol?
You may discuss the concept of your proposed project with the OPRS. To obtain guidance regarding your protocol package contact OPRS at 895-2794.
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8. When are the IRB meetings?
Click here for schedule of Social Behavioral and Biomedical IRB meetings for protocols requiring full board review.
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9. How long will the review process take?
If the protocol involves educational testing or survey procedures, does not use identifying information that can link subjects to data, and the subjects are healthy adult volunteers, the protocol may be exempt from full review. This type of protocol is reviewed via the expedited review process. You will be notified of its status within 21 business days.
If the protocol involves invasive procedures and/or vulnerable subjects such as minors, prisoners, or mentally disabled persons, full review by the appropriate Institutional Review Board (IRB) is required. The IRBs have monthly scheduled protocol review meetings. Protocols requiring full board review must be received in the OPRS at least two weeks prior to scheduled meetings. Principal Investigators may choose to make themselves available to answer questions from IRB members during the meeting.
The type of review required for your protocols will be determined by the Chair of the appropriate IRB.
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10. What is the process for notification of protocol status?
An email will be sent to the principal investigator regarding the status of the protocol. The IRB can issue an approval, approval with minor revisions, table or disapproval of the protocol. For student researchers, the notification will be sent by email and copied to the faculty advisor.
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11. Who are the IRB members?
Click here to review the IRB members.
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12. What about research involving the Clark County School District?
Projects involving students, faculty or staff of the Clark County School District must first be approved by the appropriate UNLV IRB. The protocol is then reviewed by the CCSD Research Review Committee. Click here to learn more about research with CCSD.
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13. How is the level of review for my protocol determined?
The level of risk to the human subject determines the type of review needed for the protocol. Any protocol having more than minimal risk is considered for full-committee review. Any protocol having minimal risk may qualify for expedited review or exempt certification. Researchers can not determine the level of IRB review necessary for protocol review. OPRS can give you information about the type of review your protocol may receive. Call the OPRS at 895 2794.
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14. Does a Pilot Study have to be reviewed by the IRB?
Yes. It isn't the numbers of participants that determines if review is needed. The determining factor is whether or not human subjects are involved.
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15. If I am using a pre-existing data set with or without identifiers, do I have to get IRB approval?
Yes, anytime you are conducting a systematic investigation that will contribute to generalizable knowledge IRB approval must be sought. If the data set does not have any identifiers then it will most likely fall into the exempt category. The exempt category will still require IRB review to certify that the study can be exempt. The IRB will ask the PI to specify where the data was obtained, under what circumstances, and to specify the data points that will be evaluated. If the data set does contain identifiers the study will most likely fall under the category of expedited review. Your application must specify how you have access to the data.
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16. If I am doing research on samples obtained form cadavers, do I have to get IRB review?
Please note if the samples were obtained while the subject was living, IRB review would be required.
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