APPLICATION CHECKLIST Human Subject Protection Office UConn Health Center Judy Gaffney, BA Monika...

APPLICATION CHECKLIST

Human Subject Protection OfficeUConn Health Center

Judy Gaffney, BAMonika 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.


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:

Legend: I = Initial Review C = Continuation FB = Full BoardG =General Clinical Research Center NA = Not Applicable


GCRC When Needed

Copies For FB

Check or NA

Element of Application PI Comments

IRB Review

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

43

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)

IC

43(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. )


GCRC When Needed

Copies For FB

Check or NA


IRB Review

IC

43

Investigator’s Brochure

IC

43 (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.)

IC

44 (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)

IC

15see 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.)


GCRC When Needed

Copies For FB

Check or NA


IRB Review

I 15 If available, results of any scientific review already conducted (e.g. reviews by GCRC or foundations)

G I / C 15see 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 15see 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 multi-site 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.


GCRC When Needed

Copies For FB

Check or NA


IRB Review

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 C 15 Addendum to Request Continuation

I 15 Appendix A – GCRC Resource Request

G 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)


GCRC When Needed

Copies For FB

Check or NA


IRB Review

INFORMED CONSENT (Does not pertain to exempt studies or studies that are no longer enrolling.)

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

G 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.


GCRC When Needed

Copies For FB

Check or NA


IRB Review

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.

GCRC When Needed

Copies For FB

Check or NA


IRB Review

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 re-approval of materials)

C 15 Previously approved telephone scripts/screeners (if requesting re-approval of materials)


GCRC When Needed

Copies For FB

Check or NA


IRB Review

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.


GCRC When Needed

Copies For FB

Check or NA


IRB Review

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)

G 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


GCRC When Needed

Copies For FB

Check or NA


IRB Review

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)


GCRC When Needed

Copies For FB

Check or NA


IRB Review

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


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.

GCRC When Needed

Copies For FB

Check or NA


IRB Review


GCRC When Needed

Copies For FB

Check or NA


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.


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


APPLICATION CHECKLIST Human Subject Protection Office UConn Health Center Judy Gaffney, BA Monika...

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