Transcript APPLICATION CHECKLIST - University of Connecticut Health

APPLICATION CHECKLIST
Human Subject Protection Office
UConn Health Center
Judy Gaffney, BA
Monika Haugstetter, MHA, RN, MSN
http://resadm.uchc.edu/hspo/index.html
This checklist is to be used in conjunction with new applications and
requests for continuation, excluding requests for continuations
under category 8A or 8C for which an abbreviated request for continuation
form is available for use. The checklist should be the first item in the packet
submitted to the IRB. To avoid delays in the review and approval process
investigators must ensure that all required elements are included in the IRB
submission. Investigators should check off those elements that are
applicable to their study and included in the submission packet or indicate
that the element is not applicable to their study. The PI may add clarifying comments.
For exempt or expedited request only one of each relevant document is required.
The number of copies required for full board (FB) initial (I) and continuing (C) review
are indicated.
For full board submission information must be collated into packets, i.e. each of the
15 packets contain 1 of each relevant document, and for initial review 4 of the 15
packets also contain the protocol, IB, grant and commercially available assessment
tools (as applicable to the study), and for continuation 3 of the 15 packets also contain
the protocol, IB, grant, and assessment tools, as applicable to the study. For continuing
review, commercially available assessment tools may be provided on 3 labeled compact
discs or in hard copy. Hard copy of all other documents is required.
An application and supporting documentation must also be submitted to the General
Clinical Research Center (GCRC) if any type of support is requested from the GCRC.
Investigators may choose to submit to the GCRC prior to IRB submission or in
conjunction with IRB submission. Documents that must be submitted to the GCRC are
noted with G. The application instruction form contains further instructions regarding
submissions to the GCRC.
http://resadm.uchc.edu/hspo/index.html
Legend:
I = Initial Review
C = Continuation
G =General Clinical Research Center
FB = Full Board
NA = Not Applicable
PI Name:
Submission Date:
Date Received:
Contact Name:
Funding Source:
Agenda Date:
Category of Review Requested:
(Full Board, Expedited, Exempt)
Type of Review:
(Initial or Continuing)
IRB Number (continuations only):
Study Title:
http://resadm.uchc.edu/hspo/index.html
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
General Documentation
I/C
1
This Checklist
G
I/C
15
Complete application signed by principal investigator holding
UCHC or UConn faculty appointment.
G (see
note)
I
C
4
3
Complete protocol – apart from any grant application, required
for all applications (Note: for GCRC studies the protocol is
require by the GCRC for the initial submission only)
I/C
NA for
FB
Request for Expedited Review Form (only if the intent is to
seek expedited approval)
I
NA for
FB
Request for Exempt Status Form (only if the intent is to seek
exempt IRB approval)
I
C
4
3(see
note)
The entire grant/proposal as submitted to the external funding
agency, i.e. the initial grant or the grant continuation application
as applicable (distinct from the IRB protocol). (Note: If
external funding is sought and obtained after receiving IRB
approval, the grant proposal must be submitted to the IRB as an
expedited modification to the funding source of the study as
soon as possible. If that modification is requested as part of a
FB continuation 3 copies will be required. )
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
I
C
4
3
Investigator’s Brochure
I
C
4
3 (see
note)
Standardized assessment tools or questionnaires that are
commercially available (Note: For continuing review,
commercially available assessment tools may be provided in hard
copy or on 3 labeled compact discs.)
I
C
4
4 (see
note)
Form to appoint a qualified individual to serve as a backup for
the PI in the event of the PI’s extended absence. (Note: This
form is optional and to be completed at the discretion of the PI.
However, if used the appointment will be valid only through the
IRB approval period and must be renewed at each continuation if
the appointment is to remain active.)
I
4 of
each
form
If scientific review is being requested, additional copies of 1)
protocol, 2) consent and 3) application (e.g. request when the
study requires full board review & scientific review has not been
conducted by, NIH, GCRC, FDA or other body. Submit as 4
distinct packets)
I
C
15
see
note
Pink sheets from grant reviewers (e.g. NIH, Donaghue) if there
were any comments made pertaining to human subject
protections. (Note: If external funding is sought and obtained
after receiving IRB approval, the grant proposal and relevant pink
sheets must be submitted to the IRB as an expedited modification
to the funding source of the study as soon as possible. If that
modification is requested as part of a FB continuation 15 copies of
the pink sheets will be required. If reviewed with the initial
application the pink sheets need not be submitted at continuation.)
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
I
15
If available, results of any scientific review already conducted
(e.g. reviews by GCRC or foundations)
G
I/C
15
see note
Data Safety Monitoring Plan / Data Safety Monitoring Board
information when done external to UCHC. (Note: if
incorporated into protocol please reference page numbers)
G
I/C
15
see note
Charter for Data Safety Monitoring Board when external to
UCHC (Note: if incorporated into protocol please reference
page numbers)
G
I/C
15
Findings from DSMB meetings that have occurred (for multisite trials if findings are available based on other site activity
they should be included at the time of initial application.)
I/C
15
Any survey* instruments, interview questions, or assessment
tools (including health history questionnaires) that are not
commercially available
I
NA for
FB
For exempt or expedited studies in which a consent form is not
used, a cover letter for survey instruments that contains PI
name, PI phone #, a description of purpose of survey, a statement
that participation is voluntary, that subject may skip questions
that make them uncomfortable, that completion and return of the
survey implies consent. Surveys administered by students must
also include student name, school and class affiliation, a
description of the curricular activity being fulfilled by the
research.
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
I
15
For investigator initiated studies, data collection form; screening
forms and/or case report forms.
I/C
15
Verification that protections for vulnerable populations are
addressed (Forms B, C, D, I and/or S as applicable)
APPLICATION APPENDICES / ADDENDUMS:
G
G
C
15
Addendum to Request Continuation
I
15
Appendix A – GCRC Resource Request
I/C
15
Appendix B – Internal Data Safety Monitoring Plan / Charter
I/C
15
Appendix C – UCHC as statistical, coordinating or lead institution
I /C
(see
note)
15
Appendix D - Enrollment Projections/Actual (Note: required with
initial submission when seeking approval to enroll 250 or more
subjects. Required at continuing review only when any enrollment
has occurred within the past year, regardless of whether submitted
with the initial application)
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
PI
Comments
INFORMED CONSENT
(Does not pertain to exempt studies or studies that are no longer enrolling.)
G
G
I/C
15
Informed consent form for IRB approval. (Note for continuations
the form should include the IRB # in the header)
I /C
15
Informed Consent Checklist
C
15
Previously Approved Consent Form
I/C
15
Form to request a waiver of or alteration to the requirement to
obtain informed consent (Note: Telephone screening requires a
waiver to be approved prior to collection of identifiable data.
Complete waiver is not applicable to FDA regulated studies.)
I/C
15
A written summary of the research that will be provided to
subjects if a waiver of documentation is requested (if requesting
that the consent form serve this purpose indicate so)
I
15
For NIH supported multi-site studies – the sample NIH consent
form
I
15
The DHHS sample consent form if one exists
I
15
For planned emergency research, the form to request a waiver
or alteration of consent, if applicable.
http://resadm.uchc.edu/hspo/index.html
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
HIPAA FORMS
(Does not pertain if study is no longer enrolling)
I/C
15
Authorization to Use and Disclose PHI to be approved (e.g.:
used when consent is being obtained and PHI is collected)
C
15
Previously Approved Authorization to Use & Disclose
I/C
15
(see
note)
Application for Waiver of Authorization
(example: generally used 1) with a waiver of consent when
identifiers must be retained for example from a chart review, 2)
to collect PHI during a screening phase prior to obtaining
authorization, for example phone screening in response to a print
ad)
I
15
Certification of De-identified Data
(e.g.: to create a de-identified data set from a chart review)
I
15
Certification of Limited Data Set and Data Use Agreement
(example: used to disclose indirectly identifiable information
outside of the UCHC)
NA
HIPAA does not pertain because no protected health information
is seen, collected or disclosed.
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
RECRUITMENT MATERIAL
(Does not pertain if study is no longer enrolling)
I/C
15
Recruitment material to be approved (advertisements, letters,
radio or TV scripts or final taped ads, broadcast message text, etc.)
I/C
15
Telephone scripts/screeners to be approved, including those for
receipt of calls in response to general advertisements (e.g.
receptionist scripts) or for calls initiated by the study team.
C
15
Previously approved recruitment material (if requesting reapproval of materials)
C
15
Previously approved telephone scripts/screeners (if requesting
re-approval of materials)
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
OTHER ATTACHMENTS
I
1
Proof those individuals external to UCHC have completed
human subjects training. (Note: IRB staff will verify training of
UCHC personnel via IRB records therefore training documents for
UCHC personnel are not generally required)
I
4
Final contract if available at time of IRB submission (Note: If
being negotiated concurrent with this submission please indicate
and provide a copy of the intended indemnification language for
preliminary review by the IRB. Contract language may be obtained
from the Clinical Trials Unit.)
I
15
For projects involving investigational drugs, the FDA Form 1572
I
15
For investigational drugs or devices, if the IND/E # is not
provided, a letter from the sponsor confirming IND, IDE approval.
I
15
For investigational drugs or devices, confirmation from the
manufacturer of compliance with GMP.
I
15
For IND or IDE studies, the signed Statement of Investigator
Obligations form regarding control and use of investigational
items.
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
OTHER ATTACHMENTS
I
15
Biosketch of PI if qualifications are not summarized on
application.
I/C
1
IRB Statement of Disclosure of Conflicts for all investigators,
study coordinators, persons authorized to obtain consent, and/or
persons involved in the design, conduct or reporting of the
research. (this is a project specific form and is not the same as
the annual disclosure made to the Conflict of Interest
Committee)
I/C
15
IND / IDE Safety Reports
I/C
15
Any other relevant document not addressed in this form that
will be used within the conduct of the study
C
NA for
FB
IRB approval letter showing that the convened IRB determined
study to be of minimal risk and eligible for expedited review
under category 9.
G
C
15
Any relevant multi-center trial reports
G
C
15
Audit or inspection reports (including internal audits) or
findings issued by regulatory agencies, cooperative research
groups, contract research organizations, the sponsor or the
funding agency
C
15
Annual report to FDA when UCHC PI is sponsor of IND/IDE
G
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
PROOF OF ADDITIONAL APPROVALS
I
15
Budget Workbook Approval (effective with Sept. 2007
submissions) – Required for any study that will generate a research
charge (e.g. blood draw, x-ray, drug administration etc.). (Contact
Judy Kulakofsky x7816 or Judy Kulko x1395).
I
15
Pharmacy Approval (for drug dosage, frequency, duration and
method of administration and drug storage if outside of pharmacy)
(Contact Ruth LaCasse x2085)
I/C
15
Institutional Biosafety Committee Approval for gene therapy
studies (Contact Ron Wallace x3781)
I
15
Research Safety Approval i.e. Risk Assessment Report (Contact
Steve Jacobs x2723 or Ken Price x2250)
I
15
Review and approval for conduct of study in foreign location
from foreign IRB or equivalent review body
I
15
Approval from external IRB to conduct study at outside agency,
company, clinic, etc. For studies conducted with school children, the
IRB of the School must approve the study, or the letter of permission
must state that the school does not have an IRB. If there is no IRB,
an individual with proper authority to do so must grant permission
for the conduct of the study.
I
15
Pre-application audit if UCHC PI is sponsor for IND or IDE study
(contact Judy Gaffney x7555)
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
CONTINUATIONS INCORPORATING REQUESTS For
MODIFICATION
For changes to previously approved documents e.g. consent,
HIPAA, recruitment material, investigator developed surveys /
questionnaires (Note: If changes are made to a consent form, the
version noted in the footer of the document for which approval is
being sought must be revised. )
C
15
Track changes version of the document showing what has been
added/deleted/changed
For changes to protocols or commercially available assessment
tools / questionnaires: (Note: If changes are made to a protocol,
the version of the document for which approval is being sought
must be revised.)
C
15
Copy of the relevant previously approved pages from the
protocol, assessment tool or questionnaire (i.e. prior to changes)
C
15
Copy of the revised pages from the protocol, assessment tool or
questionnaire with the proposed changes incorporated and
highlighted
http://resadm.uchc.edu/hspo/index.html
PI
Comments
IRB
Review
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
PI
Comments
IRB
Review
Noted below are some common errors/omissions that occur in IRB submission. Please take a moment to verify that following:
The IRB # is the correct number for the listed study title.
Consent and protocol versions are noted on documents (e.g. in the
footer or on the face page)
Title on Consent, HIPAA, Protocol, and DSMP/Bs Correspond
PI, Co-PIs, Coordinators and those authorized to obtain consent
have completed human subjects protection training (within past 3
yrs for UCHC employees)
For continuations, correct IRB # and Title are used
Previously approved modifications have been incorporated into the
application for initial and continuing review and into the consent
and protocol as applicable.
Professional license types and #s have been provided for personnel
performing clinical functions within the study.
http://resadm.uchc.edu/hspo/index.html
GCRC
When
Needed
Copies
For FB
Check
or NA
Element of Application
PI
Comments
IRB
Review
IRB USE ONLY
Notification for Cooperative Agreements
Hartford Hospital
CCMC
Storrs / UConn Branch
*Surveys:
Survey instruments used in exempt studies for which informed consent may not be required must contain
the following information either on the first page or on a cover letter:
- name and number of a PI to be contacted if the subject has questions,
- a brief description of the purpose of the survey;
- a statement that participation is voluntary,
- a statement that subjects may skip any question that make them uncomfortable;
- that completion and return of the survey implies consent.
In addition surveys to be administered by students must include:
- the name of the student,
- the student’s school and class affiliation
-a description of the curriculum activity that is being fulfilled by the survey.
For expedited studies for which consent is usually required investigators should submit the form to request
to alter the requirement of consent and address the issues noted above.
http://resadm.uchc.edu/hspo/index.html
Contact Information
• IRB support
– Patty Gneiting (exempt/expedited) x4849
– Donna Horne (panel 2 & 3) x4851
– Pam Colwell (panel 1 & 3) x1019
– Marcy Chasse (outgoing approvals) x8729
• HSPO
– Deb Gibb x3054
– Judy Gaffney x7555
– Monika Haugstetter x8802
http://resadm.uchc.edu/hspo/index.html