University of Pennsylvania, Office of Regulatory Affairs

3624 Market Street, Suite 301 S, Philadelphia, PA 19104-6006

Completeness Check: Required items prior to sending to Convened board

PI: Protocol #: Date:

The following items/documentation are required prior to scheduling a protocol to a board for full board review. The checked items were verified by an IRB administrator. Comments, if applicable, are provided in the “comments” field. / # / Comments
General
Face sheet: All items addressed & signed by appropriate authorities / 18
Emailed PI if incomplete or clarification needed
All required human research protections training completed. / 1
All required training not completed, emailed PI to notify them of necessary training and added to comments section the stipulation of completing training prior to approval
N/A
Protocol
Protocol summary in ORA format & addresses all the following elements: Background, Purpose/Objectives, Location, Research Design, Duration, Potential Risks, Potential Benefits, Protection of Subjects, Risk/Benefit Ratio and Consent Procedures / 18
Full protocol / 3
Grant application (minus budget & appendices) for investigator-initiated or if UPenn is prime awardee of federally funded study.
§  Added to Agenda Notes a reminder to PI that embedded protocols need IRB review and approval prior to initiation.
§  1 copy to file, 1 copy to primary reviewer, secondary reviewer and chair
§  Grant review not required for training grants, subcontracts & cooperative group research {i.e. BMT, ECOG, GOG, etc.}. / 2
N/A
Informed Consent
Study requires one ICF (submitted) / 18
Study requires multiple consents:
ICFs contain all required elements: Research, Risks, Benefits, Alternatives, Confidentiality, Compensation, Contact, and Voluntary
ADDITIONAL ELEMENTS FOR IRB MEMBER consideration (only required when appropriate) (§46.116(b)) ü if present:
A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable;
Anticipated circumstances under which the subject's participation may be terminated by the investigator w/o regard to the subject's consent;
Any additional costs to the subject that may result from participation in the research;
The consequences of a subject's decision to withdraw from the research & procedures for orderly termination of participation by the subject;
A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
The approximate number of subjects involved in the study.
Research uses screening consent (submitted)
§  Include telephone script if applicable. / 18
N/A
Waiver requested under § 46.116(d): Waiver or Alteration of Required Elements of Consent w/ justification provided. / 18
Waiver requested under § 46.117(c): Waiver of Written Documentation of Consent w/ justification provided.
N/A (no waiver requested) / 18
Hipaa
Authorization / 18
Authorization incorporated into the consent form
If yes, required elements are present:
·  List of PHI collected as part of the study
·  Who may use disclose the information
·  Who may receive the information
·  Duration of authorization or no expiration
·  Right to revoke authorization
·  Information disclosed outside covered entity may not be
protected
Waiver of authorization
N/A
Supporting Documents
Questionnaires, inventories, surveys, diaries, personality tests, quality of life assessment or other surveys or inventories, data collection forms, interview & focus group scripts, consent & recruitment scripts.
§  Exception: Widely recognized, accepted, standard tests in a given field do not need to be submitted for review.
§  Note: The IRB needs to review any scripts used in recruiting & consenting subjects. / 18
N/A
All recruitment materials, including advertisements, brochures, letters to physicians & patients, transcripts of all broadcast materials, etc.
§  Added to Agenda notes: Reminder to review and approve advertisements. / 18
Recruitment materials not available at this time
N/A
Conflicts of Interest marked yes on Section I of the Application?
If yes:
COI form, protocol & consent form copied & submitted to Coordinator for Quality Assurance
Added to Comments Section of Penn ERA the stipulation requiring CISC review prior to approval
Added to overview section of InfoED that CISC review and approval of the management plan is required prior to approval
N/A
Subparts
The following subparts apply: Primary Reviewer: Please complete, sign, & give to Administrator on the day of the meeting.
B: Pregnant Women, Fetuses, Neonates. Appendix B1 is attached.
B: Added to agenda notes section that Subpart B review is required and checked off in InfoED the appropriate vulnerable population
B: Subpart B Supplemental Form provided by PI
B: Subpart B Supplemental Form not submitted and requested from PI
C: Biomedical & Behavioral Research Involving Prisoners as Subjects: Appendix C is attached.
C: Added to agenda notes section that Subpart C review is required and alert Executive Director with Protocol Number and PI name and checked off in InfoED the appropriate vulnerable population
C: Subpart C Supplemental Form provided by PI
C: Subpart C Supplemental Form not submitted and requested from PI
D: Children Involved as Subjects in Research Appendix D is attached.
Added to agenda notes section that Subpart D review is required and checked off in InfoED the appropriate vulnerable population
D: Subpart D Supplemental Form provided by PI
D: Subpart D Supplemental Form not submitted and requested from PI
D: Assent form or process included
D: Parental Permission Form included
D: N/A
No subparts apply
REMINDER: For research involving vulnerable populations, complete data entry in PennERA
Clinical Trials Scientific Review and Monitoring Committee (CTSRMC) review required
Added to Comments/Provisions Section and Overview section of InfoED the stipulation requiring CTSRMC review (with priority score) prior to approval
N/A
Investigational Drug Service (IDS) review required
IDS number provided
IDS number pending and added to comments section of InfoED the stipulation requiring IDS number be provided when available
N/A
Study is Industry Sponsored
Billing Information Sent to Kadeda via email (for paper studies send email verifying that billing information was captured at front desk)
N/A
IND is held by the PI or a member of the study team
Member Packet provided to Administrative Coordinator for Quality Assurance (Kituria), marking “PI is IND holder”
N/A
Study involves gene transfer or element of gene transfer
IBC Review complete
IBC Review pending (add note to comments/provisions section that IBC approval is required prior to IRB approval)
Notified Executive Director and added note to overview section in InfoED that review by IBC and HRAC required prior to approval
N/A
The following appendices are attached to each packet, in addition to this form:
A1: [Completeness] Drugs, Biologics & Devices / B2: Neonates of Uncertain Viability / B4: Fetal Material
A2: Concurrent Review – IRB Administrator / B3: Nonviable Neonates
Additional comments to IRB members:
§
Pre-Reviewed by:______Date:______
IRB administrator signature

Page 1 of 3 Completeness check: Convened IRB Version: 6 June 2009