September 1, 2013
Statement of the Issue
UTD faculty, staff, students or employees who propose to engage in any research involving the use of human subjects must have prior review and approval of that activity by the Institutional Review Board (IRB) under the auspices of the Office of Research Compliance (ORC).The IRB reviews research studies to ensure they are ethical and protect the rights of the donors and participants. The committee also reviews research protocols and consent forms to determine compliance with all relevant regulations. There is no limit to the time and energy an IRB could spend on protocol review, research monitoring, continuing education, and the process of informed consent.
- The IRB operates under the Department of Health and Human Services (HHS) regulations for the protection of Human Research Subjects (45 CFR 46).
- Office of Research Compliance IRB policies
- UTD Policy and Procedures for the Payment of Research Subjects (UTDBP3036)
- HHS Regulations
- 45 CFR 46 HHS Regulations for the Protection of Human Subjects
- 45 CFR parts 160 and 164 Health Insurance Portability and Accountability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifiable Health Information
- 42 CFR part 50, Subpart F HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought
- Food and Drug Administration (FDA) Regulations
- 21 CFR part 50 FDA Regulations for the Protection of Human Subjects
- 21 CFR part 56 FDA Regulations for Institutional Review Boards
- NIH Grants Policy Statement - Part II: Terms and Conditions of NIH Grant Awards – Subpart A – Section 4.1.15 Human Subjects Protections
- NIH FAQs
- ClinicalTrials.gov and FDAAA. The FDAAA of 2007, Title VIII, expands the National Library of Medicine (NLM) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to certain trails supported by NIH funds.
- Office for Human Research Protections (OHRP)
- IRB review and approval process must be obtained either before the proposal is submitted or before a deadline set by the sponsoring agency. In most cases, IRB approval is obtained before an award is made.
- At the time of submission of a new, resubmission, revision, or renewal application status, indicate the IRB approval as “pending” in the Certifications tab in PeopleSoft.
- In the case of applications submitted to the NIH, human subject approval may be obtained “just-in-time” before the award is made. Nevertheless, the PI must take into account the time necessary to obtain final approval from ORC. A cost center will not be established unless the human subject protocol has been approved. Investigators may initiate the process with the submission of an application to IRB: (1) application for expedited or full board review, or (2) application to determine eligibility for minimal review.
- If an application has been approved and is similar to another study with a current IRB approved protocol, the investigator will need to submit an amendment to add the new application to the currently approved protocol. ORC can generate an IRB approval showing the amendment status and approval of the application related to a currently approved protocol. An approval letter for an amendment will often have the same title.
- You may not use the “approval” status on grant applications with a current IRB approval that is similar to the new application, unless the investigator has an amendment associated with the current IRB approval. An approval to an amendment can have the same title and approval dates.
- During the submission of an annual progress report, you will need a copy of an approved protocol on file in order to be in compliance with the submission of the technical report.
- For additional information, refer to the IRB process.
Considerations of IRB Applicability
The responsibilities of the IRB are applicable to all activities which, in whole or in part involve research with human subjects if:
- The research is sponsored by this institution, or
- The research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
- The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
- The research involves the use of this institution's nonpublic information to identify or contact human research subjects or prospective subjects.
Acronyms and Definitions
- CFR: Code of Federal Regulations. - The codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States.
- FDAAA: Food and Drug Administration Amendment Act
- OHRP: The Office for Human Research Protections - OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health (OASH) in the Office of the Secretary (OS), U.S. Department of Health and Human Services. OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP also supports the Secretary’s Advisory Committee on Human Research Protections (SACHRP) which advises the HHS Secretary on issues of human subject protections.