JHSPH IRB Progress Report Page 2 of 4

615 N. Wolfe St, Suite E1100 Baltimore, MD 21205
Phone: (410) 955-3193
Fax: (410) 502-0584 / IRB Use Only: IRB X £ IRB FC £
Type of Review: Expedited (single reviewer) £ Board £
Johns Hopkins School of Public Health
Institutional Review Board
Progress Report
(must be typed)
IRB Number: / IRB Approval Expiration Date:
Study Title:
Principal Investigator: / Name:
Address:
Room #: / Phone:
E-mail:
Co-Investigator(s):
(list – box expands) / Name: / Phone:
E-mail:
Student Investigator(s):
(list – box expands) / Name: / Phone:
E-mail:
Other Study Contact, Updated information:
(if applicable) / Name:
Address:
Room #: / Phone:
E-mail:
SECTION A: CONFLICT OF INTEREST
Do any of the participating faculty, their immediate family, staff or students have a financial interest (royalty, equity or consulting) in the sponsor and/or products used in this study?
No Yes: Has this been reported to the IRB previously?
No: Attach a separate memo describing the relationship
Yes
SECTION B: STUDY STATUS SINCE LAST IRB REVIEW AND APPROVAL (Check one category only)
Enrollment has not begun
Actively enrolling subjects
Enrollment closed on ______(insert date); subjects are receiving treatment/intervention
Enrollment closed on ______(insert date); subjects are in follow-up only.
Analyzing identifiable data
Analyzing de-identified data (no HIPAA identifiers, no codes or links to identifiers)
Repository (provide listing of associated research studies)
Data coordinating center activities only
SECTION C: INFORMATION ON SUBJECTS, RECORDS AND/OR SAMPLES STUDIED
1. Participants
a. Age of Population:
b. Sample size approved in the initial application:
c. Additional number approved through IRB amendments:
d. Total (sum of b and c):
2. Consented and Screened (if applicable)
Number of Adults / Number of Children / Total
Male / Female / Male / Female
a. Since last approval
b. Since original approval
c. Total number of subjects consented and screened who are eligible for the study:
Comments:
3. Consented and Enrolled (if applicable)
Number of Adults / Number of Children / Total
Male / Female / Male / Female
a. Since last approval / **
** If you have enrolled subjects using a written consent process since the last approval, submit a copy of a signed and dated consent form (you may redact the name) so we may verify that you are using the correct document version.
b. Since original approval
c. Is age range of enrolled subjects consistent with approved research plan? If not, explain in item H. / YES NO NA
d. For multi-site studies: Total number of subjects enrolled for all sites
e. IRB Approved version number(s) of consent/permission/assent form(s) used to enroll subjects (if more than one version used during approval period, indicate consent form amendment approval date):
Comments:
4. (For studies using only existing data) Data or medical records reviewed or biosamples analyzed (if applicable)
Number of Adults / Number of Children / Total
Male / Female / Male / Female
a. Since last approval
b. Since original approval
Comments:
SECTION D: STUDY ACTIVITIES DURING THIS APPROVAL PERIOD
YES NO NA
1. Have any subjects withdrawn voluntarily or been withdrawn from the study by the investigator?
If yes, explain below in Section H. /
2. Were any grievances or complaints received by you or the study staff regarding the study?
If yes, explain below in Section H
3. Are there any significant new findings from other studies or new published articles which may affect the study by: a) changing the risk-benefit assessment of the study; b) indicating a need for a change in the protocol or consent, or c) providing cause to suspend or discontinue the study?
If yes, please explain below in Section H, and inform the IRB whether the subjects have been notified.
4. During the last approval period, have there been any protocol deviations (administrative or minor departures from IRB approved study)?
If yes, attach a summary describing the protocol deviations.
5. Has an updated IRB approval been obtained from the collaborating or local institutions?
If yes, please attach a copy(ies) of any available approval(s, or submit at next review.
SECTION E. ADVERSE EVENTS AND UNANTICIPATED PROBLEMS POSING RISK TO SUBJECTS OR OTHERS, AND PROTOCOL DEVIATIONS
YES NO NA
1. During the last approval period, have there been any unanticipated adverse events or problems that were related to the study intervention and posed harm to subjects or others?
a. If yes, were they reported to the IRB? If not, explain why not.
Attach a summary describing the events/problems.
2. During the last approval period, has the profile of anticipated harmful problems or events met the expectation of frequency or severity described in the research plan and consent form?
Attach an Anticipated Event Summary Form, if applicable.
3. During the last approval period, has the profile of anticipated adverse events (in terms of frequency, severity, or specificity) changed from previous experience or from protocol expectation?
If yes, attach an explanation of the changes and whether an amendment to the research plan and/or consent document is indicated.
4. If applicable, has the Data Safety Monitoring plan (individual monitor, committee or formal board) produced any reports over the past approval period?
If yes, attach a copy of that report.
SECTION F. APPROVED AMENDMENTS SUMMARY
If the JHSPH IRB has approved any changes to your study during the past year, please summarize them below. Add more rows if necessary.
Date approved / Description of change:
1.
2.
3.
SECTION G. FUNDING
1. Current funding status
Awarded (complete # 2 below) / NB: If your funding source has changed, please submit an amendment along with a copy of any grant or contract associated with the new or additional funding.
Pending (complete #2 below)
Study not funded
Funding has ended
2. Describe the funding source:
Name of sponsor:
Proposal/award number:
Title of grant/contract:
SECTION H. PROGRESS REPORT SUMMARY FOR THIS APPROVAL PERIOD
The progress report should provide the IRB with a description of the progress of the study over the past approval period, and the study’s current status. It should provide information on the following (using as much space as is needed ):
· Progress towards achieving research objectives;
· Barriers to meeting research objectives, and strategies to overcome barriers;
· Likelihood of meeting original timelines;
· Your analysis of the study’s adverse events and unanticipated problems and any effect on the research;
· Any scientific developments affecting the equipoise, safety, efficacy or other fundamental aspect of the study;
· Your opinion as to whether the risk/benefit ratio for the study remains reasonable.
SECTION I: SIGNATURE
______
Signature of Principal Investigator Date
(signature of co-investigator or study staff is not acceptable)
Return original and one copy of this form and all supporting documentation to:
JHSPH IRB Office, Suite E1100, Bloomberg School of Public Health, 615 North Wolfe St, Baltimore, MD 21205
or submit via email to

06Oct08