Fillable IRB Renewal Application Version 01.18.2019 (South Piedmont Community College)

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IRB Renewal Application Version 01.18.2019 (South Piedmont Community College)

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IRB Renewal Application
Version 01.18.2019
Page 1 of 5
IRB Renewal Application
Principal Investigator:
Address:
Phone Number:
E-mail:
Department, school, or program you represent:
Title of Project:
IRB expiration date:
SUBJECT RECRUITMENT
What number of subjects did the IRB approve for you to enroll?
Do you wish to request a change in this number at this time? Yes* No
*If yes, you must create and submit a modification. Otherwise, your enrollment target will not be increased.
IRB Renewal Application
Version 01.18.2019
Page 2 of 5
During the
Past Year
Cumulative
Accrual
Number Enrolled: This is the number of subjects who signed a consent form; OR
who gave verbal consent on a study conducted under a waiver of documentation
of consent; OR the number of records reviewed if a retrospective study conducted
under a waiver of consent and authorization
Number of potentially vulnerable subjects enrolled (Minors, prisoners, individuals
with impaired decision-making capacity, or economically or educationally disadvantaged persons):
Number of subjects who read the consent form and/or discussed the study with
study staff as part of the consent process but refused to participate
Number of consented subjects who voluntarily withdrew
Number of consented subjects who are lost to contact
Number of consented subjects who were withdrawn by the PI
Number of consented subjects who completed the study: (all interventions and
follow-up are complete)
If no subjects were enrolled this year, please provide an explanation.
Explain the reason for all subject withdrawals (either subject or PI initiated) since initial IRB review or the last
renewal.
IRB Renewal Application
Version 01.18.2019
Page 3 of 5
Total Enrollment Report: Number of Subjects Enrolled to Date (Cumulative) By Ethnicity and Race
Note: For retrospective medical record review studies, the race and ethnicity tables below are not
necessary if the answer is “Yes” to the following statement: The medical record reviews in this study
included all eligible subjects regardless of their race or ethnicity.
Yes No
Ethnic Category
Females
Males
Unknown or
not reported
Hispanic or Latino
Not Hispanic or Latino
Unknown (Individuals not reporting ethnicity)
Ethnic Category: Total All Subjects*
Racial Categories
Females
Males
Unknown or
not reported
American Indian/ Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or not reported
Racial Categories: Total of All Subjects*
*The Ethnic Category total must equal the Racial Categories total.
STUDY PROGRESS
Please provide a narrative summary of the study progress to date. If your study is closed to enrollment and
subjects are in follow-up, please detail your follow-up.
IRB Renewal Application
Version 01.18.2019
Page 4 of 5
CONFLICT OF INTEREST
Have any conflicts of interest been identified that have not already been disclosed to the SPCC IRB? Do any of
the participating study investigators or other key personnel (or their immediate family/significant other) have a
financial or intellectual interest in, or are receiving compensation from, the sponsor or the drugs, devices or
technologies used in this research? If additional conflicts have been identified, explain the conflict and any
mitigating measures.
Do you have or anticipate (within the year) any financial relationships (e.g., consulting, speaking, advisory
boards, patents, equity, options) that could be perceived to overlap or present a conflict of interest with the
current proposal? If yes, describe the overlap.
RISK ASSESSMENT & MANAGEMENT
Since the initial IRB review or last renewal:
Have there been any events requiring prompt reporting to the IRB, such as a study-related adverse event of any
severity, injury, or protocol deviation/violation, that was both unanticipated and indicated that the research
places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm)
than was previously known or recognized? If yes, please summarize the events. State whether the incident was
promptly reported to the IRB by submitting the IRB Unexpected Event Report Form (if not already completed,
submit the form along with this application).
Has the occurrence of the event(s) changed your current risk-benefit assessment (increased potential for risk or
decreased potential for benefit to study participants)? Explain your answer and how you responded.
IRB Renewal Application
Version 01.18.2019
Page 5 of 5
DISSEMINATION OF DATA/RESULTS
Since initial IRB review or the last renewal:
Has there been any literature or new information that relates to your research, such as information about
possible risks to human subjects associated with this research or any significant new findings which may relate
to the subjects’ willingness to continue participation? If yes, please explain. (Note: Any significant new
findings which may relate to the subjects’ willingness to continue participation must be conveyed to the subjects
in the consent form.)
Have any preliminary results or publications of the research come available since initial IRB review or the last
renewal? If yes, please explain. (Note: Any significant new findings which may relate to the subjects’
willingness to continue participation must be conveyed to the subjects in the consent form.)
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Completed 2 October 2020

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