Author: URC31-9
Company: URC

PLEASE PREPARE ON THE INVESTIGATOR'S LETTERHEAD AND DELETE THIS HEADING 

This sample Agreement is for use by investigators who are participating in one or more OPRR‑recognized Cooperative Protocol Research Programs (CPRPs) when such investigators act in their own name independent of any hospital, clinic, or other institution.  An Agreement is not required for referral physicians or other physicians to whom research subjects are returned by an investigator who maintains responsibility for management of subjects.  

	AGREEMENT FOR A NONINSTITUTIONAL CPRP INVESTIGATOR

A.	Ethical Principles

1.	    (Name of noninstitutional investigator)       , hereinafter referred to as the "investigator,"  who is participating with     (Name of institution with applicable Assurance)     in one or more OPRR‑recognized Cooperative Protocol Research Programs, is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report").

2.  	Accordingly, this investigator understands and will abide by the principles of respect for persons, minimization of risk, maximization of benefit, and fairness as stated in the Belmont Report and will apply such in compliance with Federal Regulations (45 CFR 46), as amended.

B. 	Responsibilities of Investigator

1.  	This investigator acknowledges and accepts responsibility for protecting the rights and welfare of human research subjects involved in protocols of OPRR‑recognized Cooperative Protocol Programs and for complying with all applicable provisions of the OPRR‑approved Assurance under which this agreement is authorized.

2.  	This investigator assures that before human subjects are involved in such cooperative research protocols, proper consideration will be given to:

a.	the risks to the subjects,
b.	the anticipated benefits to the subjects and others,
c.	the importance of the knowledge that may be reasonably 			expected to result,
d.	the informed consent process to be employed, and
e.	the need for additional safeguards if the human subjects are especially vulnerable.

3.  	This investigator accepts responsibility for his/her performance in these research protocols and will protect human research subjects and satisfy the intent and procedures as specified in 45 CFR 46 and other Federal, state, or local laws or regulations which may apply.

  	4. 	This investigator will comply with all other pertinent procedures, such as prior review by an appropriately designated Institutional Review Board (IRB) and informed consent, that are designed to ensure effective application of protections for the rights and welfare of human subjects.

5.	This investigator will abide by full board reviews of the IRB designated in Section D of this Agreement and will accept the final authority and decisions of that IRB.

6.  	This investigator acknowledges and agrees to cooperate in the IRB's responsibility for initial and continuing full board annual reviews, record keeping, reporting and certification.  In addition, continuing reviews will be preceded by progress reports to include overall findings of the research.

7.	This investigator will report promptly to the designated IRB:

a.	any proposed changes in IRB-approved protocols, and agrees not to initiate such changes without prior IRB review and approval except to eliminate apparent immediate hazards to subjects, and
b.	any injuries to subjects or unanticipated problems involving risks to subjects or others.

8.  	This investigator will not accrue subjects on protocols of OPRR‑recognized Cooperative Protocol Research Programs prior to approval of this Agreement and without certification of full board review for each additional research activity that may be added to it (45 CFR 46.108[b]).

9.	Continuing full board reviews must be conducted at least annually and may be conducted more frequently at the discretion of the IRB (46.109[e]).  Minor changes may be expedited (46.110[b]).  Provision of emergency medical care without prior full board review is permitted (46.116[f]).  However, research data may not be used from such interventions.

10.	This investigator will not participate in convened discussion or voting of the IRB except by invited attendance to provide information to the IRB upon request (46.107[e]).

11.	This investigator acknowledges receipt of and compliance with existing Federal policies and guidance having to do with notification of sero-positivity, counseling, and confidentiality, where appropriate.

12.	This investigator will advise the appropriate officials of hospitals, clinics, or other institutions of the intent to admit human subjects who are engaged in protocols of OPRR‑recognized Cooperative Protocol Research Programs.  When admission to such an institution is planned, foreseen, or regular, that institution must possess an applicable OPRR‑approved Assurance prior to involvement of such persons as human subjects and must obtain prior authorization from the appropriate DHHS Program Office or its designee.

13.	This investigator will not delegate to others the treatment of subjects under such cooperative research protocols without prior IRB notification.

C.	Responsibilities of the Designated IRB

1.	The IRB designated in Section D of this Agreement and its institution will comply fully with the requirements of 45 CFR 46, the cited Assurance, this Agreement, and all Federal policies and guidelines, including those concerning notification of sero-positivity, counseling, and confidentiality of subjects.

2.	The IRB will require receipt of progress reports from noninstitutional investigators on at least an annual basis or more frequently depending on the degree of risk.

3.	The IRB and its institution will arrange for prompt reporting to OPRR of
 
a.	any unanticipated injuries or problems involving risks to subjects or others
b.	serious or continuing noncompliance with this Assurance or the determinations of the IRB, and
c.	any suspension or termination of IRB approval.

4.	Failure to comply with 45 CFR 46 and to act in accord with the terms of the IRB's Assurance and this Agreement will result in OPRR's suspension of IRB reviews for at least OPRR‑recognized Cooperative Protocol Research Programs until further Assurances of Compliance are considered to be satisfactory.

5.	The IRB will not employ expedited review to permit emergency medical care activities when they are to be entered into for the purpose of research.

D.  	Endorsements

The parties signing below agree that all human subjects research conducted by the investigator in conjunction with one or more OPRR‑recognized Cooperative Protocol Research Programs will be conducted in accordance with DHHS regulations for the protection of human research subjects (45 CFR 46), with the provisions of this Agreement, and with the stipulations of the designated IRB.  

This Agreement is not effective until signed by the Investigator, the Institutional Official, and the IRB Chairperson cited below.

This signed Agreement will be retained by the institution cited below and will be made available to OPRR upon request.  A copy of this agreement will be retained by the investigator.

1.	Signature of the Noninstitutional Investigator

I will abide by the provisions of this Agreement and by the stipulations of the designated IRB.

Signature:	                                                                                    	Date:                      
Name: 		                                                                          	Title:                                     
Office Address:	                                                                         

Telephone:	                                          
Facsimile:	                                          
E-mail:		                                          

2.	Signature of Institutional Official and IRB Chair
    
This institution authorizes the designation of its IRB for review of protocols to be conducted under this Agreement.

This IRB is constituted under OPRR‑approved Assurance Number (insert M or CPA #, if any ).

This institution and its IRB will abide by the provisions of this Agreement and of the Assurance cited above (if any).  

Institutional Official					IRB Chairperson

                                                         	:  SIGNATURE  :                                           
                                                         	:       NAME        :                                           
                                                         	:       TITLE:	                                           
                                                         	: INSTITUTION:	                                           
                                                         	:     ADDRESS   :	                                           

                                                         			                                           
                                                         	:         DATE       :                                            
                                                         	:       PHONE      :	                                           
                                                         	:    FACSIMILE  :                                            
                                                         	:        E-MAIL     :                                            

02/19/97