Institutional Review Board

Institutional Review Board at Tallahassee Memorial HealthCare, Inc. Form 4g

RETROSPECTIVE STUDY PROGRESS REPORT

THIS FORM MUST BE TYPED
HAND WRITTEN FORMS WILL NOT BE ACCEPTED.
Last IRB Approval Date:
Study Expiration Date:
IRB #:
Study Title:
Name of Principal Investigator:
(If a TMH only study, put PI name here OR if a Multi-center Study, put sponsor PI name here & TMH PI name as the Intramural PI.)
Email: / (This could be a university, commercial sponsor, etc.)
Address:
Phone:
Fax:
Name of Intramural Principal Investigator at TMH:
Email: / Address:
Phone:
Fax:
Research Coordinator: / Phone #: Email: Fax:
Detail current funding sources, awards, grants (if applicable):
List other IRBs having jurisdiction over study:
For projects that receive or have submitted application for federal funding, submit one complete copy of the grant/continuation application/NIH Progress Report applicable to this study.
A. / Study Status:
1. Indicate the status of your study by clicking an “X” next to the box next to the appropriate selection below.
Study not yet started.
Open to enrollment/chart review is ongoing.
Closed to enrollment. Date Closed to Enrollment:
Closed to enrollment, follow-up and data analysis only.
Attach copies of all study documents still in use. Include copies of the most recent IRB approved consent/assent form(s), including any foreign language consent/assent form(s), surveys, questionnaires, diaries, and all recruitment material, including print and/or all audio advertisements flyers, colleague letters, etc.
2. Please provide: Version & Date Current Consent: Version & Date Current Protocol:
If your protocol or informed consent does not currently indicate a version date, attach a reformatted version of the protocol with the last IRB approval date inserted in the footer.
B. / Subject Enrollment Status
Guidance:
1. Number of subjects enrolled = number of subjects who have signed a consent.
2. For chart reviews, number of subjects enrolled = number of charts that have been reviewed.
1. / Indicate date enrollment began at this site:
2. / Indicate the number of subjects enrolled at this site, during this approval period:
3. / Indicate the total number of subjects that have been enrolled at this site, since this project was initially approved:
Were any of the subjects who have been enrolled minors? Yes No
If Yes, were any of them wards of the state? Yes No
4. / If this a multi-site study, indicate the total number of subjects enrolled study wide (sponsor has this #):
5. / What is the number of subjects you anticipated enrolling at this site for this protocol?
6. / How many subjects were withdrawn from the study at this site to-date?
How many subjects were withdrawn from the study at this site during the last approval period?
Describe the circumstances of the subjects withdrawn from the study at this site during the last approval period (if applicable):
7. / Are signed consent/assent forms for this site, if appropriate, for each subject available for inspection upon request? Yes N/A
If YES: attach copies of the consent/assent forms of the two most recently enrolled study subjects during this approval period. (If you have only enrolled one subject during this approval period, attach a copy of that subject’s signed consent form.)
C. / Investigators/Key Personnel-Collaborating Responsible Investigators
List the names of investigators/key personnel – collaborating responsible investigators on this protocol. Indicate those who are obtaining informed consent from subjects. If Resume/CV indicating the individual’s qualifications to participate in research is not on file, please attach it. N/A = Closed to enrollment.
Obtaining Informed Consent / Name / Evidence of Human Research Protections Education/Experience Attached / Conflict of Interest Attached
IRB Form 3 / Resume/CV Submitted
Previously
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No

If additional space is needed, please continue on a separate page.

D. / Conflict of Interest
See Conflict of Interest Guidelines for guidance.
Have you or anyone listed on this study had a change in relationship with the study sponsor during this approval period (e.g., consulting, board position, stock ownership opportunities?)
Yes – There has been a change in relationship with the sponsor. Submit a new Disclosure of Conflict of Interest Questionnaire IRB Form 3.
No – There has been no change in relationship with the sponsor.
E. / Protocol Update
Provide a brief narrative of the progress of the study to date. Include any protocol modifications that affect subject participation and safety:
F. / Protocol Consent Modifications
For guidance, click on 8.5 Modifications. Click here for Modification Request form.
Have all protocol/consent modifications been submitted to the IRB? Yes No If not, please submit them at this time.
G. / Protocol Violations
For guidance, click on 8.7 Protocol Violation. Click here for Report of Protocol Violation form.
Have any major protocol violations occurred during this approval period? Yes No
If YES: Have they been reported to the IRB? Yes No
If a major protocol violation has not been reported, you must do so immediately using IRB Form 8c.
Have any minor protocol violations occurred during this approval period? Yes No
If Yes, complete and attach IRB Form 8e: Minor Protocol Deviation Table.
H. / Serious Adverse Events/Unanticipated Problems
For guidance click on, 8.8 Serious Adverse Events/Unanticipated Problems
Click here for forms Report of Serious Internal Adverse Events and Report of Serious External Adverse Events.
Have there been any Reports of Serious Internal Adverse Events (SAEs) during this approval period? Yes No
If YES, have they been reported to the IRB? Yes No
If not, report immediately using a Report of Serious Internal Adverse Events IRB Form 7a.
How many Internal SAEs occurred during this approval period?
Were the Internal SAEs reported to the sponsor and/or appropriate agencies? Yes No
If no, report immediately.
ATTACH A BRIEF SUMMARY OF INTERAL ADVERSE EVENTS REPORTED THIS PERIOD.
How many Internal SAEs have occurred since the study started?
How many SAEs have occurred at all sites since the study started (Your monitor has this information)?
Have you had any complaints about how the study is being handled from any subjects, i.e., billing, handling insurance, informed consent process, etc.,? Yes No
If YES, describe the situation and any remedial action that was taken:
I. / Data Safety Monitoring Board (DSMB)
Has a DSMB or safety monitoring committee been established for this study? Yes No
If YES, a copy of the most recent DSMB/safety monitoring committee report is:
Attached Unavailable Already submitted – Date submitted:
J. / Relevant Findings/New Information
Has there been any recent study related literature, findings or other relevant information, especially information about risks associated with this research? Yes No If YES, provide a brief summary including a justification for continuation of the study.
K. / STUDY POPULATION, RESEARCH & HIPAA AUTHORIZATION
How will you obtain the list of subjects?
How many records will be reviewed?
Are the records hard copies? Yes No
Are the records electronic copies? Yes No
Who will review the charts?
What is the clinical role associated with the source patients described in the records?
Check off any identifiers that you will be accessing, recording or disclosing among the following:
PHI Identifiers / Accessing / Recording / Disclosing
1 / Patient/Subject Name
2 / Address Street Location
3 / Address Town or City*
Address State*
Address Zip Code*
Elements of date except year related to person, i.e., date of birth, admission or discharge dates, date of death.
4 / Telephone Number
5 / Fax Number
6 / Electronic Mail (email) address
7 / Social Security Number
8 / Medical Record Number
9 / Health Plan Beneficiary Numbers
10 / Account Numbers
11 / Certificate/license Numbers
12 / Vehicle identification numbers and serial numbers including license plate numbers.
13 / Medical Device Identifiers
14 / Web URLs
15 / Internet Protocol (IP) Addresses
16 / Biometric Identifiers (finger and voice prints)
17 / Full Face Photographic Images
18 / Any unique identifying number, characteristic or code.
18. How will research data be collected and maintained?
19. How will information be recorded? Data Collection Sheet (Provide a Copy)
Electronically (Provide template and explain procedure)
Describe your plan to protect identifiers from improper use or disclosure:
Will there be a link (code) to identifiers? Yes No
List all locations of records you are accessing:
List any outside entities, i.e., sponsor, insurance companies, regulatory agencies, data management groups, etc., to
whom PHI will be disclosed:
Describe how PHI will be kept confidential so, that those not materially involved will be unable to view or record this
information:
Are you obtaining authorization to use or disclose PHI? Yes No If NO, complete Sections I & II.
26. Are you requesting a partial waiver of authorization for screening or recruitment? Yes No If YES, complete Section III.
If, after collecting the data and returning the chart or data source to the appropriate location, you need to collect any
additional data or to verify any of the collected data for a subject, will it be possible for you to identify and access the
source data again based solely on the information recorded in your data sheet/database? Yes No
Charts will be accessed to review information dating from to (give exact dates, i.e., 1/1/05 to 7/30/05).
How will confidentiality be protected?
What are the potential risks (including breach of confidentiality) and/or benefits to the subjects or society?
Attach a copy of the data collection form.
Section I Request Yes No / Waiver of HIPAA Authorization Notification Request
(If you are using a Limited Data Set, you do not need to request a Waiver of HIPAA Authorization.)
According to HIPAA Privacy Regulations, in order to use or disclose an individual’s PHI in the conduct of research without
the express authorization of the individual, the use or disclosure must not represent more than minimal risk to the
subjects. IRB approval of a waiver of HIPAA authorization will be contingent on the following:
a) Explain why the research could not practicably be conducted without the waiver:
b) Explain why the research could not practicably be conducted without the access to and use of PHI:
c) Will PHI be reused or disclosed to any other person or entity except as required by law, for authorized oversight of the
research project or other research for which the use or disclosure of PHI would be permitted by regulation.
Yes No If YES, describe how/to whom:
Section II Request Yes No / Limited Data Set
The Privacy Rule allows a covered entity to use and disclose PHI included in a limited data set without obtaining an
authorization or documentation of a waiver or an alteration of authorization. Click here for complete guidance.
Of the 18 PHI items listed in Section I, items with an (*) may be included and considered a “limited data set.” Use of
data under the provision of a limited data set requires the signing of a data use agreement by the researcher (the
recipient of the PHI in the limited data set.
Will you be using a limited data set for your study, i.e., you checked only those boxes with the items in red with an
asterisk *?
Yes No If YES, attach a completed Data Use Agreement.
Section III Request Yes No / Partial Waiver of HIPAA Authorization for Screening/Recruitment Request
If it is impracticable to obtain a subject’s prior authorization, i.e., the researcher does not have access to the patient
records, the treating clinician is unable to approach patients on behalf of the researcher, etc., the researcher may ask the
IRB to grant a partial waiver of the patient’s authorization for screening recruitment purposes.
a) Describe how data will be collected and used:
Note: Information collected through a partial waiver for recruitment cannot be shared or disclosed to any other person or entity.
b) Why do you need the PHI? (Check All That Apply)
Protected health information is required to determine eligibility.
Identifiers are necessary to contact the individual to discuss participation.
Other: Explain:
c) Why can’t the research practicably be conducted without the waiver? (Check All That Apply)
I don’t have access to the medical records/contact information of the targeted population.
There is no treating physician to assist in recruitment of the targeted study population.
The targeted study population will not be exposed to advertisements/media or any other institutional
programs or activities that would provide the opportunity for screening or recruitment.
Assistance from the treating clinicians has been historically minimal producing sub-par accrual.
Other: Explain:
______
Informed Consent – See IRB Guidelines Section 9 for Guidance.
If you will be obtaining informed consent from subjects:
1. Where will informed consent be obtained? Non-TMFM Physician’s/Researcher’s Office Clinic
Telephone TMFM Physician’s/Researcher’s Office* Emergency Center* Tallahassee Memorial Hospital*
Other N/A *Informed Consent must be documented in TMH medical record.
2.. Will consent be document by signature on a written consent form? Yes No N/A
Request for Waiver/Documentation/Elements of Informed Consent Section:
Section I Request Yes No / Waiver of Informed Consent
The IRB may waive the requirement to obtain informed consent, if one of the two sets of criteria is met:
Check the box next to the criteria that justifies your request for a waiver of informed consent. Provide a
detailed explanation in your protocol.
1. The research or demonstration project is to be conducted by or is subject to the approval of state or local
government officials and is designed to study, evaluate, or otherwise examine
(i) public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in methods or levels
of payment for benefits or services under those programs.
AND
2. The research could not practicably be carried out without the waiver or alteration.
Justification for request of waiver:
OR ALL OF THE FOLLOWING MUST BE MET.
1. Research involves no more than minimal risk to subjects.
2. The waiver or alteration will not adversely affect the rights or welfare of the subjects.
3. The research could not practicably be carried out without the waiver or alteration.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Justification for request of waiver:
Section II Request Yes No / Waiver of Documentation of Informed Consent
The IRB may waive Documentation of Informed Consent for some or all of the subjects if one of the following conditions
is met:
Check the box next to the criteria that justifies your request for a waiver of documentation of informed consent.
Provide a detailed explanation in your protocol.
The only record linking the subject to the research would be the consent document and the principal risk would be
the risk of breach of confidentiality. Provide the location of the detailed explanation in your protocol.
OR
Research involves no more than minimal risk of harm to the subjects and involves no procedures for which written
consent is normally required outside of the research context. Provide the location of the detailed explanation in
your protocol.
Section III Request Yes No / Waiver of Elements of Informed Consent See IRB Guidelines Section 9.3 for guidance.
If it can be justified, the IRB may approve a consent procedure which does not include or which alters some of the
required elements of informed consent. Which elements of informed consent do you wish to be waived and why?
L. / EXPEDITED VS FULL BOARD REVIEW

Determine if the research qualifies for Expedited Review. Read all sections before making a final determination. “Stop” indicates Full Board Review is necessary. Research qualifying for expedited review may require written informed consent. Inclusion on this list merely means that the activity may be eligible for review through the expedited review procedure. However, when the specific circumstances of the proposed research are considered, it may be determined that a higher level of review is necessary. Check the relevant boxes. Research may qualify for expedited review if it: