The Seton/UT HS IRB is charged with the following mission: To determine and certify that all human subjects research projects (regardless of funding) conform to the regulations and policies regarding the health, welfare, safety, rights, and privileges of human subjects set forth by the Department of Health and Human Services (DHHS) in 45 CFR 46 and the Federal Drug Administration (FDA) in 21 CFR 50 and 56. These goals include ensuring that each research participant is informed of their rights and are able to provide informed consent. Researchers must assure through verified training that the welfare of their research participants is of paramount importance. It is noted that the IRB follows ethical standards put forth in 45 CFR 46, 21 CFR 50 and 56 and relevant state and local regulations and procedures.
Ascension Seton Family of Hospitals formally grants the IRB the following authorities, relative to the protection of human subjects:
- To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted by the organization;
- To suspend or terminate approval of research that is not being conducted in accordance with requirements or that has been associated with unexpected serious harm to participants;
- To observe, or have a third party observe, the consent process;
- To observe, or have a third party observe, the conduct of the research; and
- To indicate that officials of the organization may not approve a protocol that has not been approved by the Institutional Review Board.
Scope and Applicability
The procedures set forth in the Ascension Seton Research Administration Manual are applicable to all persons desiring to use humans (including identifiable private information) as subjects in research and related activities, including research for which investigational devices or drugs are used. Ascension Seton requires all research investigators:
- To be directly affiliated with Ascension Seton Family of Hospitals or UT Austin Dell Medical School or linked to a principal investigator who is directly affiliated with Ascension Seton Family of Hospitals or UT Austin Dell Medical School;
- To ensure all investigators and study personnel (both internal and external to the institution) comply with all relevant IRB determinations, federal and state regulatory requirements, and human participant protection standards; and
- Have the appropriate expertise and training to conduct research at a Ascension Seton facility.
Federalwide Assurance (FWA)
Through the FWA and the Terms of the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR 46. The FWA is the only type of assurance currently accepted and approved by Office of Human Research protections (OHRP). The FWA system requires each legally separate entity that engages in federally-supported human subject research to obtain an FWA.
Ascension Seton holds the following registrations:
UT Austin holds the following registrations:
Collaborative research activities at off-site locations are subject to special procedures for coordination of research review and may involve more than one IRB responsible for research oversight. In these cases, the IRB has established additional procedures to define the responsibilities of each institution, coordinate communication among responsible IRB committees, and manage information obtained in off site or multi-site research to ensure protection of human subjects.
The IRB may enter into formal agreements with other facilities, which are not legal entities, of the Ascension Seton Family of Hospitals to provide research review (i.e., to act as the IRB of record), to rely on other institutions for research review, or to cooperate in review. The IRB enters into these types of arrangements through an IRB Authorization Agreement.
Research Involving Human Subjects
The IRB must review all research that involves human subjects performed at Ascension Seton facilities, as described below.
DHHS Regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(d)) For purposes of IRB review, we further define the following terms:
A “systematic investigation” as an activity involving a prospective plan that incorporates:
- Organized collection of quantitative and/or qualitative data, or biological specimens, and
- Analysis (or anticipation of analysis) of those data or specimens to answer a question or questions.
- “Generalizable knowledge” is information based on results or findings that are expected: to be reproducible, and apply broadly with the expectation of predictable outcomes.
FDA Regulations defines clinical investigation as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. (21 CFR 50.3(c), 21 CFR 56.103(c), 21 CFR 312.3(b), and 21 CFR 812.3(h)).
DHHS Regulations define human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (45CFR 46.102(f)). We further define the following:
- Intervention includes both physical procedures by which data are gathered (e.g., blood draw) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication (e.g., phone call or email) or interpersonal contact between the researcher and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Private information must be individually identifiable — that is, the identity of the subject is or may readily be ascertained by the investigator or associated with the information — in order for obtaining the information to constitute research involving human subjects. See the Not Human Subjects Research guidance if your research involves only unidentifiable/de-identified or coded private information or biological specimens.
- FDA Regulations define a human subject as an individual who becomes a participant in research, either as a recipient of the test article or as a control. [21 CFR 50.3(g), 21 CFR 56.103(e), 21 CFR 312.3(b), and 21 CFR 812.3(p)]
- A subject may be either a healthy individual or a patient.
- If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.
Note: Under limited circumstances, research involving only unidentifiable or coded private information or specimens is not human subjects research. Also review the Quality Improvement (QI) and Quality Assurance guidance, as well as the Quick Guide: Activities Needing IRB Approval, to learn more about what activities need IRB review and approval.
What Requires IRB Review
Investigators seeking guidance regarding whether an activity is human subjects research should consult with Research Administration for help with the initial determination of whether the proposed activity is considered human subjects research or quality improvement; and whether IRB review and approval is required.
If research involves the use of a food, biologic, nutritional, or food supplement that might fit the FDA definition of a ‘drug,’ RA staff will review this definition in the Federal Food, Drug, and Cosmetic Act Section 321(g)(1) to determine whether the research involves use of a drug. If the research involves a drug, RA staff will consult the FDA regulations 21 CFR 312.2(b) to determine whether the drug is exempt from the requirement for an IND. If an IND is required, the IRB will not review the research and Research Administration staff will return the protocol to the investigator with a written explanation. If research involves the use of a device that might fit the FDA definition of a ‘device,’ RA staff will review this definition in the Federal Food, Drug, and Cosmetic Act Section 201(h) to determine whether the research involves the use of a device.
If the research involves the use of a device, RA staff will consult the FDA regulations 21 CFR 812.2(c) to determine whether the device is exempt from the requirement for an IDE. If an IDE is not required, the protocol may be reviewed by the IRB. If an IDE is required, RA staff will evaluate whether the sponsor or investigator has claimed that the device is not significant risk, not banned, and the research meets the requirements of 21 CFR 812.2(b). If not, the IRB will not review the research and the RA staff will return the protocol to the investigator with a written explanation.
Otherwise, the IRB will review the protocol and consider whether the device is not significant risk, using the Investigational Device Exemption Checklist. If an investigator or sponsor claims a device is not significant risk, then the IRB will review the research involving the investigational device at a convened meeting. The IRB will determine whether the device is not significant risk by reviewing the criteria in 21 CFR 812.3(m). If the IRB determines that the device is not significant risk, it will document that determination in the Primary Reviewer Checklist and it will be documented in the minutes along with the IRB’s rationale for the decision. Otherwise, the IRB will disapprove the research, and notify the investigator, and, sponsor, if applicable.
Using an External IRB
There are instances where studies can use an external IRB for approval and oversight of the study. Research Administration must approve a study’s use of an external IRB prior to initiation. An investigator may request to use an external IRB when completing the Site Approval Tool and Research Administration will evaluate the request. If acceptable, a one-time IRB Authorization must be in place between Ascension Seton IRB and the external IRB before the research project can begin, unless an agreement is already in place between the Ascension Seton IRB and the external entity.
A letter to sponsors about IRB membership and function is available upon request by emailing the IRB.