IUPUI AND CLARIAN INSTITUTIONAL REVIEW BOARDS & SUBCOMMITTEES REVIEWS
NCI CIRB FACILITATED REVIEW FORM

Principal Investigator:       		

IRB Study Number:  

THIS FORM MUST BE NEATLY TYPED.  (DO NOT TYPE ON THE REVERSE SIDE OF ANY FORMS).  Note:  To check a box on this form, double-click the box and select “Checked” under “Default Value.”

Section I:  Investigator Information
Principal Investigator:       	Department:       	
                                                  (Last, First, Middle Initial------must have faculty/staff status or faculty sponsor must sign)
Building/Room No.:       	Phone:       	E-Mail:       	
Contact Information:
Name:       	Address:       		Phone:       	
	Fax:       	E-Mail:       	
Protocol Title:       
Cooperative Group:       	Study Identifier:       	

Section II:  BRIEF Study Description
A.	Describe the general purpose and nature of the study (in lay terms).

     

Section III:  Performance Site

	General Clinical Research Center (GCRC)*	
	IU Cancer Center*
	IU Medical Group Primary Care Clinic (IUMG-PC), including Wishard primary care clinics
	IU Medical Group Specialty Clinic (IUMG-SC)
	Methodist Beltway Centers
	Methodist Hospital
	Methodist-Affiliated Centers/Private Practices
	Riley Hospital
	University Hospital
	Wishard Memorial Hospital*
		Hospital/ER
		Non-primary care
		  Regenstrief Health Center
		  Wishard Specialty Clinics
		  OB/GYN Clinics
	Clarian North
	Clarian West
	Other:       

* Additional information or submission may be required prior to initiating the study.  Please check with the specific performance site for additional information.

Section IV:  Recruitment
A.	Describe how potential subjects will be initially identified (include specific source, e.g. databases, medical records, advertisements, newsletters, self-referral, physician referral, from clinics, etc.):
     

B.	Describe how potential subjects who are identified will be contacted (e.g. letter, phone call, face-to-face) and who will be contacting them (e.g. their physician, research coordinator, nurse, etc.).  Include a copy of all information to be shared with or intended to be seen by potential subjects.

     

C.	Will health information be accessed in order to identify and/or to determine eligibility of potential research subjects, which could include the records of the PI and co-investigators?
		 Yes.  Continue with item 1 immediately below.
		 No.  Continue to Section V.

1.  Please check all the recruitment strategies below that will be utilized. 

Please be aware that recruitment includes identification, review of records to determine eligibility or any contact to determine a potential subject’s interest in a study.

			a.	Care Provider: Recruitment will be done by the researcher who is a physician, dentist, nurse or other licensed independent practitioner who has provided care for the patient.
Neither an Authorization from the Subject nor approval to Waive Authorization from the IRB is required.

			b.	Authorized Delegate – Same Organization: Recruitment will be done by a researcher who did not provide care for the patient, but who will act as an authorized delegate of the treatment provider and who is part of the same Department or practice plan.  (In the case of the Departments of Pediatrics, Surgery and Medicine, this will be limited to providers within the same Division.) This may include the researcher’s Coordinator as long as the Research Coordinator is part of the same Division, Department or Practice Plan as the PI or co-investigator.  The researcher must obtain approval from the treatment provider to act as a representative contacting the potential subject.  For example: “I am a colleague of Dr. “X”, or I work for Dr. X who gave me permission to contact you regarding….”  However, the IRB will judge the appropriateness of this approach on a case-by-case basis.

Neither an Authorization from the Subject nor approval to Waive Authorization from the IRB is required.

			c.	Authorized Delegate – Separate Organization: If the researcher is not the treatment provider and is not part of the same Division, Department or practice plan of the treatment provider, then contact must be made as follows:  (NOTE: This includes Research Coordinators who are not part of the treatment provider’s Division, Department or practice plan.).  Please check all that apply.

	The treatment provider will direct the prospective subject to contact the researcher. 
Neither an Authorization from the Subject nor approval to Waive Authorization from the IRB is required. 
	The treatment provider will obtain an authorization from the potential subject to release the subject’s demographic and/or health information to the researcher.  
Submit an Authorization for recruitment for IRB Approval.
	Neither of the previous options applies to this study.  A waiver of authorization will be required, but will only be allowed in limited circumstances where the appropriate justification is provided to the IRB.
Complete the Waiver of Authorization Section on this Checklist. 

			d.	Self Referral – A subject is responding to an ad for a specific study, or places a cold call regarding research studies in general.  
	If you need to do a basic initial screening, you may gather minimal information necessary to determine whether the individual is eligible for further screening and/or enrollment.  For instance, obtaining the individual’s contact information and explaining two or three major inclusion/exclusion criteria would be acceptable.  Covering the entire Informed Consent or an exhaustive list of inclusion/exclusion criteria does not constitute a “basic” initial screening. 
Neither an Authorization from the Subject nor approval to Waive Authorization from the IRB is required. 
	If you need to gather additional detail about an individual’s health to determine the individual’s eligibility, an authorization or waiver of authorization is required.  Please note that a telephone script must be submitted unless an authorization will be obtained.
Submit an Authorization for recruitment for IRB Approval or Complete the Waiver of Authorization Section on this Checklist.
	If you wish to add an individual’s information to an IRB-approved recruitment database for future research, an authorization or waiver of authorization is required.  (See database questions below.)
Submit an Authorization for recruitment for IRB Approval or Complete the Waiver of Authorization Section on this Checklist.
	If you wish to refer the individual to another research area/department, you must give the potential subject the researcher’s contact information*: 
Neither an Authorization from the Subject nor approval to Waive Authorization from the IRB is required.
	Recruitment practices that were approved prior to April 14, 2003, which do not fall into any of the above listed categories.
Complete the Waiver of Authorization Section on this Checklist.
* This does not prohibit or interfere with the ability to refer patients for treatment purposes to other providers.

		  e. 	Recruitment Databases
	Instructions: This section applies to databases that are developed and/or used exclusively for research or recruitment purposes and not for patient care.  Select from the Recruitment Strategies ABOVE for recruitment strategies involving clinical databases (e.g. physician patient databases, CareWeb, Regenstrief, etc.).

			1.  A recruitment database that includes health or demographic information will be developed and used to identify and recruit potential research subjects.  NOTE: If you plan to use this research database as a recruitment tool for future research projects, then a separate research database protocol should be submitted to the IRB for approval.

	Please describe:      
		
				2.  An existing IRB-approved recruitment database will be used for this project.  

		Please Provide the IRB # for the approved Recruitment Database Protocol:      

			3.  An existing research database (i.e. data that was previously collected for research purposes and not patient care) will be used for recruitment for this project. 

		Please describe:      

Submit an Authorization for recruitment for IRB Approval or Complete the Waiver of Authorization Section on this Checklist. 

	2.  Waiver of Authorization for Recruitment

		a.	Will you obtain a waiver of authorization for recruitment only?  

			Yes.  See Note and complete # 2 below 
			No.  Will you request a waiver of authorization for the entire study (recruitment, enrollment and study procedures)?
	Yes.  Complete Section XIII of the Summary Safeguard Statement
	No.  No further action required

NOTE: Just because you obtain a waiver of authorization for recruitment does not mean that you will receive a waiver of authorization for enrollment.  If you obtain waiver of authorization, you will be required to track the disclosures of health information for a period of six years. 

		b.	Please address the following three criteria: 

1.  	Explain how this recruitment process involves no more than minimal risk of loss of privacy to the subject:

     

			i.	Describe the plan for protecting the identifiers from improper use and disclosure.
			     

		ii.	Describe the plan to destroy the identifiers at the earlier opportunity that is appropriate for the research study.  Identifiers may only be maintained following completion of a study if there is a legitimate reason for maintaining the data (e.g. required by law, etc.)

		     

		iii.	Provide written assurances that the identifiable health information will not be re-used or disclosed to any other person or entity, except as required by law, for authorized oversight of the project or for other permitted research purposes.

     

2.	Explain how the research could not be practicable conducted without waiver of authorization or an alteration to the authorization form.

     

3.	Explain how the research could not be practicably conducted without access to and use of the individually identifiable health information.

     

IRB Approval of Waiver of Authorization:

Signature:						Date Approved:						

Section V:  lead site

1.	Is IUPUI/Clarian the lead site?
	No.  Continue to the next section.
	Yes.  Describe how you will manage communication and information from other sites such that all participants are protected:      

Section VI:  Confidentiality & Safeguards

A.	Check the items below to explain how confidentiality and privacy of data collected for the purpose of the research study will be protected.  Keep in mind that all members of the research team should only gather or share the minimum amount of PHI needed for the study.  (See the HIPAA Glossary for more details regarding the Minimum Necessary rule.)   

1.	Data Source (Please check all that apply)
a.		Treatment or Test Results, Medical and/or Dental Records, etc.: 
	Paper 
	Film
	Electronic (e.g. CareWeb or Regenstrief Medical Record System, VA CPRS (VA medical record system), patient care database, etc.)
b.		Interviews (Phone or Face-to-Face)
c.		Survey or Questionnaire
	Paper 
	Electronic 
d.		Video 
e.		Audio
f.		Photographs
g.		Other (Please describe):            

2.	Data Recording / Collection Method (Please check all that apply)
a.		Computer:  
	Laptop
	Hard Drive
	Local Shared Drive
	Web-based 
	CDs, Floppy Disks, etc.
	Other (Please describe):           
b.		PDA (Personal Digital Assistant)
c.		Paper (e.g. Notes, Case Report Form, etc.)
d.		Video
e.		Audio
f.		Other (Please describe):            

Please describe how you will safeguard data for all the Data Recording / Collection Methods described in VIII.A.2. by completing #3, #4 and #5 below.  Please check all that apply.

3.	Secure Storage 
a.	Who will have access to the individually identifiable information/data?
 Principal Investigator			 Research Coordinator		 Co-Investigators
 Governmental Agencies 		 Research Sponsor, Monitor, Other Research Organizations
 Other (Please describe – e.g. BioStats, outside multicenter collaborators, or other colleagues not listed on the
      Summary Safeguard Statement, etc.):           

b	Please describe the measures you are taking to safeguard the information/data:
 Locking cabinets and doors
 Information is located in an area with limited public access
 Computers and/or files will be password-protected
 PDAs and removable media (such as CDs, diskettes, etc…) will kept in a secure location
 Regular back-ups of electronic data.  NOTE: All electronic data should be backed up on a regular basis.
 Describe any other measures you are using to safeguard the data:           

4.	Secure Disposal
a.	How long will you retain the data before discarding?
 Minimum of 3 years for non-health data		
	 Minimum of 7 years for health data, per Indiana State law	
	 Per sponsor requirements			
	 Indefinitely
 Other (Please describe):           
 
b.	How will you discard the data?
 Paper will be shredded				 Delete files from or destroy diskettes and CDs*
 Permanently delete data from computers and PDAs*	 Other (Please describe)           
		
5.	Sharing Data
For this purpose, sharing may include releasing, transmitting or providing access to research and health data within the research team, outside the university, to research sponsors, etc.  You must use reasonable safeguards when sharing any form of research data, health or non-health.  *See the IUPUI/Clarian SOP for Subject Privacy and Confidentiality and the HIPAA Glossary for more details.)

a.	Will you share data in any of the following formats?  
	Non-Health Data only.
	De-identified Data.
	Limited Data Set.  (NOTE: A Data Use Agreement may be required)
	Identifiable Data (i.e. includes patient identifiers, names, initials, Subject ID numbers, etc. - Please answer items 1. and 2. below.)
1.	Indicate which secure method(s) of transmission will be used?  Check all that apply:
	  Secured web site
	  Encrypted email
	  US Postal Service or other trackable courier services (not campus mail)
	  Fax in a secured area
	  Shared drive with password protection
	  Personal delivery by authorized research personnel
	  Private telephone conversation to authorized personnel
	  Other:  (describe)

2.	Will you share identifiable health data with anyone not listed on the Summary Safeguard Statement or the Authorization? 
1.  No – Proceed to Section IX.
2.  Yes – These people must be added to the summary safeguard statement and the authorization form:

 Data will not be shared – Please explain:            

Section VII:  Informed Consent

	A.	I WILL be obtaining informed consent from all subjects.  I am NOT requesting any waivers, exceptions or alterations to the informed consent document or process.  Provide a copy of the informed consent statement(s) for review.

		1.	When (in what timeframe) and where (what setting) will consent take place?  Indicate any waiting period between informing the subject and obtaining consent.

     

	2.	Who will be responsible for obtaining initial and ongoing consent?  When this responsibility is delegated to someone other than the PI, explain how the individual(s) will be prepared to obtain informed consent for the research activity.

     

3.	Explain how subjects’ privacy will be protected during the consent process.    This refers to how access to subjects will be controlled (e.g. time, place, etc. of consent procedures).

     

4.	Explain what additional safeguards are in place to protect the rights and welfare of subjects likely vulnerable to coercion and undue influence.

     

Section VIII:  Authorization for the Use/Disclosure of Protected Health Information

A.	If you are obtaining written informed consent an Authorization for the Release of Health Information for Research must be obtained from every subject at the time of enrollment/consent.  Provide a copy of the Authorization for review.

1.	Will health information be accessed prior to obtaining the informed consent (e.g. for recruitment or screening purposes)?
	 No.  Explain:       
	 Yes.  

Section IX:  documentation of SRC approval

For studies specifically wishing to enroll cancer patients, approval must first be obtained form the Scientific Review Committee (SRC) prior to submitting to the IRB.  Check here  to indicate that a copy of the SRC approval is appended to this submission.  Call 317/274-0934 for additional information.

Section X:  Data Safety Monitoring Plan
For all research that is greater than minimal risk (i.e. requires full IRB review), a Data Safety Monitoring Plan must be developed.  This is a plan to assure the research includes a system for appropriate oversight and monitoring of the conduct of the study to ensure the safety of subjects and the validity and integrity of the data.

	The DSMP is contained in the protocol.  State where in the protocol the description is located:       	
NOTE:  Ensure that all points outlined below are addressed in the description in the protocol.  If any points are not addressed, within the protocol, they should be addressed below.

If the protocol description of the DSMP does not include the items below, please address:

1. 	Who will be responsible for the data and safety monitoring?  (Examples include:  a DSMC or DSMB, medical monitor, investigator, independent physician)  Clarify if this individual or committee is independent from the sponsor and/or investigator.	
     	
	
2. 	What will be monitored.  (Examples include:  data quality, subject recruitment, accrual, and retention, outcome and adverse event data, assessment of scientific reports or therapeutic development, results of related studies that impact subject safety, procedures designed to protect the privacy of subjects)	
     	
	
3. 	What are the procedures for analysis and interpretation of data, the actions to be taken upon specific events or endpoints, the procedures for communication from the data monitor to the IRB and site, and other reporting mechanisms?	
     	
	
4. 	What is the frequency of monitoring?  (The appropriate frequency of data and safety monitoring will be dependent on the nature and progress of the research; however, monitoring must be performed on a regular basis (e.g, at least annually).	
     	
	
5. 	What information will be reported to the IRB?  (Minimally, the IRB requires the following information at the time of continuing review: 1) frequency and date(s) of monitoring; 2) summary of cumulative adverse events; 3) assessment of external factors (i.e. scientific reports, therapeutic developments, results of related studies) that impacted the safety of subjects; 4) summary of subject privacy and research data confidentiality outcomes; and 5) any changes to the risk-benefit ratio.	
     	

Section XI:  Infectious Agents/Radiation
Does the research involve any of the following materials or agents:
A.	infectious materials (pathogens, live vaccines, retroviral vectors, etc.)?					 No	 Yes
B.	other potentially infectious material (blood, urine, biological samples, etc.)					 No	 Yes
C.	radiation / radioactivity (e.g. x-rays, nuclear medical scans) in addition to what is used for standard clinical treatment?
													 No	 Yes

Note:  Investigators are not required to submit studies to the IRB prior to submitting it to Radiation Safety if radiation beyond standard of care is involved.  Concurrent IRB and radiation safety review is permissible.  At Methodist, nothing further is required (as the Research Review committee includes a radiation review, after study submission).  

Section XII:  Gene Therapy
A.	Does this study involve the use of non-cancer-related gene therapy? 
		No.
	Yes.  Has the proposal been submitted to the GCRC Advisory Committee?  [NOTE: It is a requirement of the School of Medicine for all non-cancer related gene therapy studies to be reviewed by the GCRC Advisory Committee.  Additionally, it is the GCRC’s requirement that approval be granted from them prior to IRB submission.]
	No.  You must submit to the GCRC Advisory Committee before you can submit to the IRB.  Please call 317/278-3446 for more information.
	Yes.  Include a copy of that approval with this study submission.

B.	Does this study involve the use of cancer-related gene therapy?
		No.
	Yes.  Has the proposal been submitted to the Scientific Review Committee (SRC)?  [NOTE: It is a requirement of the School of Medicine for all cancer-related gene therapy studies to be reviewed by the Scientific Review Committee (SRC).]  
		 No.  You must submit to the SRC before you can submit to the IRB.  Please call 317/274- 0934 for more information.
		 Yes.  Include a copy of that approval with this study submission.

Section XIII:  FINANCIAL Conflict of Interest
A.	Do any of the investigators listed under Section XXI. of this document have a financial conflict of interest associated with the conduct of this study?  (Required financial disclosures include: (1) an equity interest that exceeds $10,000 or represents more than a 5% ownership interest in any one enterprise or entity (equity in a privately held entity for which the value is not known will be treated as above the 5% threshold), when aggregated for the Academic Appointee or Staff Member and his or her Family Members; (2) salary, royalties, or other payments expected to exceed $10,000, when aggregated for the Academic Appointee or Staff Members and his or her Family Members over the twelve month period.; (3) compensation to the Academic Appointee or Staff Member and his or her Family Members of any amount that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest; (4) proprietary or other financial interest by the Academic Appointee or Staff Member and his or her Family Members in the product to be used in clinical trials including, but not limited to, a patent, trademark, copyright or licensing agreement; and (5) fiduciary, director, board, or executive position of the Academic Appointee or Staff Member and his or her Family Members in any enterprise or entity regardless of whether the position is compensated).

	 No  
	 Yes.  List names of individuals with such financial interest:       	

Please refer to the SOP on Conflict of Interest Reporting to the IRB at:  http://www.iupui.edu/~respoly/human-sop/human-sop-index.htm for additional information.

Section XIV:  Investigational Drugs

 N/A. No investigational drugs or devices used in this study.

Investigational Drugs
A.	Name of Drug Sponsor:       	
	Name of Drug:       	IND Number*:       	

	1.	Either submit documentation from the FDA or sponsor verifying the IND number or if the IND number is included in the sponsor’s protocol or investigator’s brochure, check here: .

	2.	Will services of the Investigational Drug Services (IDS) be used?
		 Yes
		 No.  The investigator must demonstrate understanding of the handling and control of investigational test articles by reviewing the Investigational Drug Accountability SOP.  Check here  to confirm this has been done.
	
B.	Study Phase:		 II	       II/III	   III	      III/IV	 IV

C.	If this study involves the investigational use of a marketed drug or biologic, and in the opinion of the investigator does not require submission of an IND, six conditions must be met (e.g. responses to conditions listed below must be “yes” for an IND to not be required).  Please respond to the following conditions:
	No	Yes	
•	The study is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug.			
•	The study is not intended to support a significant change in the advertising for the product.			
•	The study does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.			
•	The study is conducted in compliance with the requirements for IRB review (21 CFR 56) and informed consent (21 CFR 50).			
•	The study is conducted in compliance with the requirement concerning the promotion and sale of drugs (21 CFR 312.7).			
•	The study does not intend to invoke (21 CFR 50.24).			

Section XV:  Investigators
List the principal investigator and any co-investigators* and their respective departments.  (If there are multiple investigators, please indicate only one person as the principal investigator; others should be designated as co-investigators).  

* For purposes of completing this section, the definition of a co-investigator is 1) someone who is playing a role in the design, conduct, or reporting of the research, including persons obtaining consent; or 2) someone who is making independent decisions about the inclusion or exclusion of participants in the study.  These co-investigators are further delineated in Part B and C based on whether they are directly interacting or intervening with subjects.  Those co-investigators that are directly interacting or intervening with subjects (listed in Part B) must pass the human subjects protection test.  

Persons listed in section B. must provide the IRB with documentation of their agreement to participate in the research.  This can be accomplished by either having each individual provide his/her signature next to his/her name below on the copy of this document submitted to the IRB or by having each individual submit a memo (or email) to the IRB reflecting agreement to participate in this specific protocol.  

Note that individuals listed in sections A. and B. below are required to pass the IUPUI/Clarian human subjects test requirement unless special circumstances apply.  For more information, refer to http://www.iupui.edu/%7Eresgrad/Human%20Subjects/human-menu.htm. 

A.	Principal Investigator:	Department

     	     

B.	Co-investigators:  (Please include the respective department)
List those directly interacting or intervening with subjects (including persons obtaining consent):
Note:  All investigators in this category must pass the online human subjects protection test and submit a memo/e-mail (or sign next to their name below) to acknowledge their participation in this study.

Name	Department

     	     

C.	List other co-investigators who are not directly interacting or intervening with subjects:

     

D.	If this study is a collaboration with investigators at unaffiliated institutions, and our IRB is providing the review and approval for their role in the study, list all such co-investigators,* their respective institutions, and specify their role and what procedures they will be performing:

Name of Co-investigator	Institution	Role	Procedures performed	
     	     	     	     	

Section XVI:  Investigator Statement of Compliance
I assure the Board that all procedures performed under the project will be conducted in strict accordance with those federal regulations, University and Clarian Health Partners policies that govern research involving human subjects.  I agree to submit any local deviation from the project (e.g. change in principal investigator, research methodology, subject recruitment procedures, etc.) to the Board in the form of an amendment for IRB approval prior to implementation.  I further agree to submit evidence of NCI CIRB actions to the Board.  
Note:  This form and any additional material requested by the Board will not be processed unless they are neatly typed and legible, properly prepared, and signed personally by the principal investigator.

Signature of Investigator:	Date:	

Section XVII:  IRB Approval
This protocol, informed consent statement, authorization, and/or waiver of authorization for use of human subjects in research has been reviewed and approved by the Indiana University-Purdue University Indianapolis Institutional Review Board or the Clarian Institutional Review Board for a maximum of a one year period beyond the final approval date unless otherwise indicated as follows:	

Authorized IRB Signature:	IRB Approval Date: