HSPP- April-May-June, 2021- Newsletter
What is Exempt Human Subjects Research?
Exempt human subject research is a project that does constitute human subjects research but is exempt/excused from satisfying the requirements of the Department of Health and Human Services (HHS) policy for the protection of human research. Research activities that involves no more than minimal risk are exempt from the human research protection regulations when the only involvement of human subjects falls within one or more of the exempt categories described in the Request for Exemption Form .doc. While the research may be exempt from certain regulatory requirements, human subject protections, such as plans for protection of privacy and confidentiality of data, are still applied per accreditation standards and internal policies.
As per UConn Health’s Human Subjects Protection Program Policy 2011-009.2.pdf – Institutional Review Board – Exemptions, investigators cannot make the determination as to whether a human research project meets the criteria of exempt research. This determination is to be made by the Institutional Review Board (IRB).
To aid those who need to decide if an activity is research involving human subjects that must be reviewed by the IRB for Exempt determination, the Office of Human Research Protection (OHRP) published graphic charts titled Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.104(d)? .
What is Non-Exempt Human Subjects Research?
If the project does not fall within one or more of the defined categories of exemption, then it is not exempt and must satisfy the regulatory criteria for approval. Non-Exempt human subject research may be a project for which research activities involve no more than minimal risk to subjects and all of the procedures in the research are described in the categories of research that may be reviewed by the expedited procedure. The expedited review procedure means that only one member of the IRB needs to conduct the review. This type of research is reviewed on a daily basis and there are no submission deadlines.
Non-Exempt human subject research may also be a research project involving greater than minimal risk and/or involving procedures not described in the categories for exempt status or expedited review. This type of research would have to be reviewed by the convened IRB committee and submission deadlines will apply.
In order to obtain IRB review investigators must complete and submit an on-line Application in the iRIS submission system and attach to that application the relevant submission checklist and corresponding documents.
IRB Frequently Asked Questions
Q: Who is consider “Key Study Personnel” in a Human Subjects Research Study?
A: The key study personnel (KSP) are those people designated by the Principal investigator as back–up principal investigator, co-investigators, study coordinators, data managers, or consenters on an application submitted to the IRB for review and approval. The KSP often include individuals involved in the study through an interaction or intervention with research subjects for research purposes or those reviewing or accessing identifiable data for the research. Individuals who will be interacting with research subjects during the course of a study, but only in their regular non-research employment capacity (e.g. a nurse or phlebotomist) should not be listed as KSP if they are not associated with the study as researchers.
Q: Do key study personnel added to a study need to complete Human Subjects Training?
A: Yes. All key study personnel listed on an IRB application must complete training in the protection of human subjects. Training completed through the Collaborative IRB Training Initiative (CITI) is the most used method of training to fulfill this requirement. Training must have been completed within the past three years to be considered current.
Q: I have little experience in IRB submissions. Where can I find information about the IRB process for a new proposed study?
A: The Human Subjects Protection Program offers a one-hour general educational session for study coordinators and investigators who plan to conduct Human Subjects Research at UConn Health. This training provides an overview of the research proposal submission and maintenance process. Registration is required. Interested staff should e-mail Mayra Cagganello at cagganello@uchc.edu. Individuals who need study specific guidance on preparing IRB submissions are encouraged to request assistance from the Education Specialist as noted above. WebEx orientation sessions are available on a daily basis.
Recent Articles Published by a Central IRB
ADVARRA IRB:
FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect: This article provides answers to a series of questions regarding FDA inspections process.
Among the questions answered in this article are:
- What is the likelihood an investigator-initiated Investigational New Drug application (IND) and non-IND study would undergo an FDA inspection at an academic center?
- For multisite studies, does FDA inspect all sites, or might one specific site be selected to be monitored?
- How do you suggest research staff/coordinators educate clinical investigators (CIs) that they need to pay attention to study oversight and the FDA will not hold coordinators responsible by FDA if things go awry in the study conduct?
- Do you anticipate inspections to pick back up as more people become vaccinated and COVID-19 cases decrease? Will the FDA catch up on missed investigations?
Cell and Gene Therapy vs Small Molecule Research: Understanding the Difference Cell and gene therapy’s popularity has grown exponentially in the past year. This article provides an overview of how cell and gene therapy research is different from traditional drug development. Among the issues discussed in this article is that sites need to build the required infrastructure for conducting cell and gene therapy research safely and successfully.
Educational Resources for Investigators
OHRP Luminaries Lecture Series
The Office of Human Research Protection (OHRP) has posted a series of lectures on human subjects research protections titled: “Luminaries Lecture Series.” Many of these lectures are recordings of keynote addresses at OHRP-sponsored Research Community Forum (RCF) events. Among the topics presented in these lectures are “Use of eConsent in Human Subjects Research,” “Making Mobile Clinical Trials a Reality” and “Big Data, Privacy, and the Public Good.” To access these Luminaries Lecture Series please click here.