Managing Research Studies
Managing research studies efficiently and effectively requires leadership, planning, collaboration, and communication.
The Principal Investigator (PI) is responsible for the overall management of an approved study. Management of a study encompasses the ethical, technical, administrative and fiscal elements of the research study.
The PI is responsible for ensuring that the research team is oriented to the protocol and aware of their responsibilities. The study team should have specific details about the plans to accomplish the goals and procedures of the study, inclusive of plans for recruitment, consenting of subjects, data and safety monitoring, and protections for privacy and confidentiality.
The PI is also responsible for ensuring that adequate resources are available to conduct the study, including equipment, supplies, and storage space at UConn Health and in any outpatient facilities. Prior to seeking IRB approval, the PI should communicate with the leadership of any ancillary areas that may become involved with the research to ensure the area can commit the necessary resources (e.g. staff, hospital beds, equipment etc.).
Communicating with appropriate areas to ensure resources are available and educating all members of the research team on their roles and responsibilities will help to ensure that the research is implemented in a safe and compliant manner.
Human Subjects Training- Educational Requirements
I completed CITI Training under my affiliation with a former institution. Is that CITI Certificate valid at UConn Health?
CITI Training completed within the last three years may satisfy the UConn Health IRB requirements. However, the IRB reserves the right to require that an individual complete additional modules.
The IRB encourages individuals who are new to UConn Health (e.g. a new student, new faculty member) to complete CITI training under their new affiliation with UConn Health. When completing modules under the new affiliation to UConn Health the CITI Program will provide credit for any overlapping modules completed under another institutional affiliation and will require completion of any modules that are specific to UConn Health requirements.
To affiliate one’s account in the CITI Program with UConn Health, individuals should log into the CITI program, and click on “Add Affiliation” listed under the “Courses” Menu. To find UConn Health in the drop down box, the following words “University of Connecticut” must be typed. Then, select “University of Connecticut Health Center”. To complete the process, check the box next to the statement: “I AGREE to the Terms of Service for accessing CITI Program materials” and check the box with the statement: “I affirm that I am an affiliate of University of Connecticut Heath Center.” Last, click on “Continue.”
To select the correct learning group and courses, follow the “Course Enrollment Questions” posted at https://ovpr.uchc.edu/services/rics/hspp/citi-instructions/
I will be conducting a Clinical Trial at UConn Health. Should I complete the “Good Clinical Practice (GCP)” course?
It depends on whether or not the clinical trial is supported by the National Institutes of Health (NIH). The GCP training is a requirement if the clinical trial is an NIH funded trial. The Human Subjects Protection Program/IRB strongly encourages researches who are involved in clinical research trials not supported by the NIH to complete the GCP course.
Reporting Non-Compliance to the IRB
Principal Investigators are responsible for being knowledgeable of and following the IRB policy for reporting non-compliance (i.e. Policy 2009-002.0.pdf – Reporting Non-Compliance to the Institutional Review Board). Noncompliance is defined in Policy 2011-007.0 as any action that is taken or occurs that is not in accordance with an IRB approved study, IRB polices or regulations or that represents a failure to follow the requirements and/or determinations of the IRB.
Principal investigators (PIs) should report to the IRB any non-compliance that was within the control of the research team within 5 business days of becoming aware of the event. To do so, PIs should complete and submit a Problem Report Form through the IRB online submission system, iRIS. When the non-compliance was not within the control of the research team it should be reported at the time of continuing review. If continuing review is no longer a requirement, non-compliance that was not within the control of the research team should be documented and tracked by the study team and available for review should the study be selected for audit.
Whenever any non-compliance is reported, the investigators should describe the details of the event, the underlying causes of the noncompliance and the actions that have been taken or will be taken to correct the problem and to prevent a subsequent occurrence. PIs should also describe whether the occurrence suggests that subjects or others are placed at an increased risk of harm. This information allows the IRB to accurately assess the situation to determine whether the non-compliance rises to the level of serious and or continuing non-compliance as defined in IRB Policy 2011-007.0 – Definitions Applied to Policies. If the event does rise to the level of serious and/or continuing non-compliance there may be additional reporting required if the research is Federally funded or subject to FDA oversight.
If there is any question about whether reporting is required it is always better to err on the side of caution and report the issue. PI’s are also encouraged to contact one of the Regulatory Specialists to discuss any questions about reporting requirements.
Are you responsible for updating a ClinicalTrials.gov record?
Are you responsible for updating a ClinicalTrials.gov record? You may want to subscribe to the new ClinicalTrials.gov bulletin “Hot off the PRS!” The bulletin details recent updates to the Protocol Registration and Results System (PRS) as well as new resources for PRS users. Enter your email address next to “Receive Updates” at the top of their webpage to subscribe. For help with registering your record or related questions, contact UConn Health’s PRS Administrator, Ellen Ciesielski at 860.679.6004 or firstname.lastname@example.org.
IRB Forms – Update
The Instructions for Requesting Reliance Upon Advarra IRB.docx have been update to reflect the new contact names at Advarra IRB. Investigators may contact Kathleen Rankin or Ashley Carpenter for guidance in making a submission to Advarra IRB.
Recent Articles Published by Central IRBs
- Gene Therapy: Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements by reading How Centralized IBC Review Can Benefit Gene Therapy Research
- IRB Review of Participant Compensation: IRBs are in charge of reviewing the amount of payment, as well as the method and timing of disbursement, to ensure that the payment plan does not present potential undue influence. Participant compensation is often a complicated matter, what an IRB should consider is discussed at Compensating Clinical Trial Participants: The Basics
Western IRB (WCG):
- Participants Training has a direct impact in achievement the objectives in Clinical trials: Lack of training, particularly for patients, creates variability detrimental to trial findings, says Nathaniel Katz, founder and chief science officer of WCG Analgesic Solutions. To learn more about this topic click on: Lack of Training Compromises Trial Results.
- Recruitment: Recruitment is what drives a study. No patients, no research, right? Sites, sponsors and CROs know they need to do it, but they don’t really consider all the implications or differing strategies to recruitment .To learn more about this topic click on: What You Don’t Know About Patient Recruitment Can Impede the Success of Your Trial
Reporting Race and Ethnicity Data when Requesting Continuing Review
“Researchers assumed that what they learned about white male participants could safely applied to anybody, regardless of gender, race, ethnicity or other variables. We now know that this is not true. When you are communication about research results, it’s vital not only to explain how a study was done, but was being studied,” says Dr. Eliseo J. Perez-Stable, Director of the National Institute on Minority Health and Health Disparities in his article titled: Communicating the Value of Race and Ethnicity in Research.
In August of 2001, The National Institute of Health (NIH) issued a policy which adopted the 1997 Office of Management and Budget (OMB) revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all grant applications, contract and intramural proposals and for all active research grants, cooperative agreements, contract and intramural projects. The goal of this policy is to ensure that the distribution of study participants by sex/gender, race and ethnicity reflects the population needed to accomplish the scientific goals of the study.
UConn Health IRB Main Consent Form Template .doc contains an Addendum Form titled “Personal Census Data”. This form provides a mechanism for capturing the representation from racial and ethnic groups in research studies conducted at UConn Health. This addendum form provide instructions to investigators, to present this form to subjects at the time of consent for completion.
The categories and definitions in the “Personal Census Data Sheet” are commonly used for federal data collection purposes. The form’s standards consist of two categories for ethnicity: “Hispanic or Latino” and “Not Hispanic or Latino” and five categories for race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.
Investigator with full board studies or expedited submissions requiring continuing review are required to report this data at the time of request for continuing review.
Investigator should count all subjects who provided consent since the start of the study, including subjects who were screen failures or withdrew. Investigators should indicate by gender the number in each racial/ethnic group. The total reported numbers should equal the total reported since the start of the study in the first table (e.g. first request for continuing review).
The table to be completed within the continuation form in IRIS is provided here for reference.
|Hispanic or Latino|
|Not Hispanic or Latino|
|American Indian/Alaska Native|
|Native Hawaiian or Other Pacific Islander|
|Black or African American|
|More Than One Race|
|Unknown or Not Reported|