CONTINUING REVIEW OF PREVIOUSLY APPROVED RESEARCH
For Full Review Research
HENDRIX COLLEGE HUMAN SUBJECTS REVIEW BOARD
The U. S. Department of Health and Human Services regulations for the protection of human subjects
require that previously approved Full Review aresearch involving human participants be re-approved at
intervals appropriate to the degree of risk, but not less than once per year.
Note: Research that qualified for Exemption or was reviewed via Expedited
procedures does not require continuing review.
Continuing review and re-approval of research must occur before the one (1) year anniversary date of the
original approval or the research must stop (no new participants enrolled and no research conducted with
previously enrolled participants). Also, re-approval cannot occur more than 30 days prior to the
expiration date. The expiration date is the anniversary date, which is listed on the original approval
memo. It is the investigator’s responsibility to apply for continuing review in a timely manner.
Federal regulations allow up to two (2) annual continuing reviews for a total project approval time of
three years. If the research will continue beyond three years, a new application will need to be
completed and submitted to the HSRB for review before the expiration date.
Continuing review and re-approval will be conducted through the same review process as the original
application: Full committee review. An exception is made if Full Review research is in the “data
analysis only” stage; projects in this phase are not subject to continunig review.
PROCEDURES FOR CONTINUING REVIEW
Submit the following documents 1) electronically as attachments to HSRB@hendrix.edu and 2) in person
as paper copies with original signatures to the HSRB Co-Chair, Dr. Lindsay Kennedy, DWR 140:
1)
A completed Continuing Review Form (see next page)
2)
A copy of the most recently approved version of your original application (including all supporting
documents), with any proposed modifications bolded or underlined.
Note: If your research has been completed since the last review, complete the Final Report
For Research Form instead of applying for continuing review.
CONTINUING REVIEW FORM
For Full Review Research
HENDRIX COLLEGE HUMAN SUBJECTS REVIEW BOARD
Project Title:
HSRB Approval Code #:
Investigator Name(s):
Faculty Sponsor (if student research):
Original Expiration Date:
1) Research Study Status (Check One):
Work Not Yet Started (no participants recruited) State Reason:
Active Project (participant enrollment and/or involvement continues)
2) Participant (and Control) Status Report:
a. Are participants still being enrolled? Yes No
b. Number of participants enrolled to date:
c. Number of participants proposed for coming year:
d.
Yes No
Is the total number of participants different than in the
original approved application?
If YES, please explain.
4) Report briefly on the progress of the research to date and/or on the research findings.
Before beginning this for, please make sure you are using the most recent version of Adobe Acrobat and can save your entries.
4) Since the last review, were there any:
a. Yes No Adverse events or unanticipated problems involving risks
to participants or others?
If Yes, please explain:
b. Yes No Participant withdrawals from the research?
If Yes, please explain:
c. Yes No
Complaints about the research?
If Yes, please explain:
6) Yes No
Do you wish to make any modifications to your currently approved
application?
If Yes, please summarize your proposed modifications below in a list form.
SIGNATURES: I certify to the best of my knowledge that the information provided herein is
an accurate reflection of the research study and that the research will continue to be conducted
in full compliance with Federal Regulations and Hendrix College policies and procedures
governing human participant research.
___________________
_____________________________________________________
_____________________________________________________
Signature of Investigator(s)
Date
___________________ _____________________________________________________
Signature of Faculty Advisor (if student research) Date
To submit your continuing review form for review, please submit one electronic copy to HSRB@hendrix.edu AND one signed paper copy
(with original signatures) to the mailbox of the HSRB Co-Chair (Dr. Lindsay Kennedy, DWR 140).
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