AGREEMENT FOR AN INDEPENDENT INVESTIGATOR

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THIS AGREEMENT IS FOR USE BY INVESTIGATORS WHO ARE PARTICIPATING IN AN HHS CONDUCTED OR SUPPORTED RESEARCH PROJECT WHEN ACTING IN THEIR OWN NAME INDEPENDENT OF ANY HOSPITAL, CLINIC, OR OTHER FACILITY. 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. PLEASE PREPARE ON LETTERHEAD AND DELETE THIS HEADING.

AGREEMENT FOR AN INDEPENDENT INVESTIGATOR

A. Ethical Principles

1. (Name of independent investigator), hereinafter referred to as the "investigator", and cooperating with (name of awardee institution) on research project numbered (award number) which is entitled ______________________________, 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 shall abide by the principles of respect for persons, minimization of risk, maximization of benefit, and fairness as stated in the Belmont Report and shall 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.

2. This investigator assures that before human subjects are involved in research, 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, as amended, 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 below 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, recordkeeping, reporting and certification. In addition, continuing reviews will be preceded by progress reports to include overall findings of this project.

7. This investigator specifically acknowledges the need to promptly report the following 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 agrees not to accrue subjects on protocols of this award prior to approval of this Agreement and without certification of full board review for each additional research activity that may be added to it, as required by 45 CFR 46 (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 understands that he or she may 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. The 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. When applicable, this investigator shall advise the appropriate officials of hospitals, clinics or other institutions of the intent to admit human subjects who are engaged in protocols of this project. If such admission to these hospitals, clinics and other institutions is planned, foreseen, or regular, the institution is required to negotiate an appropriate Assurance with HHS prior to admission, if that institution does not have an OPRR-approved Assurance which applies to this research project.

13. This investigator agrees not to refer subjects to other sources of maintenance treatment under protocols of this project without prior IRB notification.

14. This investigator accepts responsibility for forwarding a copy of this Agreement to the Chairperson of the IRB designated as providing full board review for protocols of this award.

C. Responsibilities of the Designated IRB

1. The IRB and its host institution, which are designated below agree to abide by 45 CFR 46, the cited Assurance, this Agreement, and all Federal policies and guidance concerning notification of sero-positivity, counseling, and confidentiality, where appropriate

2. It is agreed that the IRB shall require receipt of progress reports from independent investigators on at least an annual basis or more frequently depending on the degree of risk.

3. It is agreed that the IRB shall promptly report to OPRR any serious or continuing noncompliance and any suspension or termination of the IRB approval.

4. It is agreed that the IRB shall promptly report to OPRR any injuries to subjects, unanticipated problems involving risks to subjects or others, and any changes in this research activity which are reviewed and approved by the IRB.

5. Changes in IRB membership shall be promptly reported to OPRR as they occur via submission of a revised and redated IRB membership roster.

6. Failure to comply with 45 CFR and act in accord with the terms of the IRB's Assurance and this Agreement shall result in OPRR's Suspension of IRB reviews for at least this project until further assurances of compliances are considered to be satisfactory.

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

D. Endorsements

1. Designation of the IRB of Record

a. This investigator has designated and reached agreement with officials of an institution, cited below, which is participating in this award, entitled _________________________, and will abide by the determination and requirements of its IRB. The IRB of record for this award, cited below, is in possession of an applicable OPRR-approved Assurance (enter # of applicable Assurance and IRB).

b. Statement for Signature of the Independent Investigator

I assure that I will abide by the above principles and responsibilities of this Agreement in accordance with 45 CFR 46, as amended.

Signature: _________________________ Date: ________

Name: _________________________Title: ___________
Office
Address: _______________________

Phone: _________________________

2. Institutional Official and IRB Chair Signatures

The institution cited below is in possession of an OPRR-approved Assurance applicable to this project (enter Assurance number). The IRB and institution agree to be cognizant of the contents of this Agreement and to act in concert with all its requirements, in addition to those of its own applicable OPRR-approved Assurance. A copy of the current IRB membership roster is attached.

Institutional Official
_______________________:
_______________________:
_______________________:
_______________________:
_______________________:
_______________________:
_______________________:
_______________________:

SIGNATURE
NAME
TITLE
INSTITUTION
ADDRESS

DATE
PHONE

IRB Chairperson
:_____________________
:_____________________
:_____________________
:_____________________
:_____________________
:_____________________
:_____________________
:_____________________

HHS Approving Official

This agreement complies with the requirements of Part 46, Title 45 of the Code of Federal Regulations and is only valid for the named independent investigator and research activities of the specified award.

Unless extended by OPRR, this Agreement expires upon termination of this DHHS award. This Agreement must be renegotiated with OPRR upon competing renewal of this award, when and as requested.

Signature:____________________________________Date:______________________

Name: __________________________________________
Title: ___________________________________________
Address: ________________________________________
Phone: __________________________________________
Agreement Number: ___________________

Revised 6/23/95

Agreement for an Independent Investitator

INSTITUTIONAL REVIEW BOARD (IRB) MEMBERSHIP

[Please Resubmit as Changes Occur]

DATE: ____________________

NAME OF INVESTIGATOR PROVIDING THIS ASSURANCE: _______________________________ ASSURANCE NUMBER: ____________________

NAME OF INSTITUTION WITH THE IRB: ________________________________________________ ASSURANCE NUMBER: ____________________

MEMBER NAME

FIRST M.I. LAST

HIGHEST DEGREES EARNED

PRIMARY SCIENTIFIC OR NONSCIENTIFIC SPECIALTY

AFFILIATION WITH
INSTITUTION ABOVE?
(YES/N0)

ADDRESS AND PHONE NUMBER FOR CHAIRPERSON ONLY

*

IRB CHAIR NAME:

ADDRESS:

PHONE:

FAX:

E-MAIL:

SIGNATURE:___________________________________

NOTE: Each IRB shall include at lease one member whose primary concerns are in NONSCIENTIFIC areas, as well as one member who is NOT OTHERWISE AFFILIATED with this institution.

Please review 45 CFR 46.107 for other IRB membership requirements.

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* DENOTES CHAIRPERSON
** DENOTES ALTERNATES (IF ANY, DENOTE MEMBER FOR WHOM ALTERNATE WILL SERVE
NV DENOTES NON-VOTING MEMBERS

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Updated June 23, 2000

A.	Ethical Principles
1.	(Name of independent investigator), hereinafter referred to as the "investigator", and cooperating with (name of awardee institution) on research project numbered (award number) which is entitled ______________________________, 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 shall abide by the principles of respect for persons, minimization of risk, maximization of benefit, and fairness as stated in the Belmont Report and shall 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.
2.	This investigator assures that before human subjects are involved in research, 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, as amended, 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 below 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, recordkeeping, reporting and certification. In addition, continuing reviews will be preceded by progress reports to include overall findings of this project.
7.	This investigator specifically acknowledges the need to promptly report the following 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 agrees not to accrue subjects on protocols of this award prior to approval of this Agreement and without certification of full board review for each additional research activity that may be added to it, as required by 45 CFR 46 (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 understands that he or she may 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.	The 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.	When applicable, this investigator shall advise the appropriate officials of hospitals, clinics or other institutions of the intent to admit human subjects who are engaged in protocols of this project. If such admission to these hospitals, clinics and other institutions is planned, foreseen, or regular, the institution is required to negotiate an appropriate Assurance with HHS prior to admission, if that institution does not have an OPRR-approved Assurance which applies to this research project.
13.	This investigator agrees not to refer subjects to other sources of maintenance treatment under protocols of this project without prior IRB notification.
14.	This investigator accepts responsibility for forwarding a copy of this Agreement to the Chairperson of the IRB designated as providing full board review for protocols of this award.
C.	Responsibilities of the Designated IRB
1.	The IRB and its host institution, which are designated below agree to abide by 45 CFR 46, the cited Assurance, this Agreement, and all Federal policies and guidance concerning notification of sero-positivity, counseling, and confidentiality, where appropriate
2.	It is agreed that the IRB shall require receipt of progress reports from independent investigators on at least an annual basis or more frequently depending on the degree of risk.
3.	It is agreed that the IRB shall promptly report to OPRR any serious or continuing noncompliance and any suspension or termination of the IRB approval.
4.	It is agreed that the IRB shall promptly report to OPRR any injuries to subjects, unanticipated problems involving risks to subjects or others, and any changes in this research activity which are reviewed and approved by the IRB.
5.	Changes in IRB membership shall be promptly reported to OPRR as they occur via submission of a revised and redated IRB membership roster.
6.	Failure to comply with 45 CFR and act in accord with the terms of the IRB's Assurance and this Agreement shall result in OPRR's Suspension of IRB reviews for at least this project until further assurances of compliances are considered to be satisfactory.
7.	The IRB shall not employ expedited review to permit emergency medical care activities when they are to be entered into for the purpose of research.
D.	Endorsements
1.	Designation of the IRB of Record
	a. This investigator has designated and reached agreement with officials of an institution, cited below, which is participating in this award, entitled _________________________, and will abide by the determination and requirements of its IRB. The IRB of record for this award, cited below, is in possession of an applicable OPRR-approved Assurance (enter # of applicable Assurance and IRB).
	b. Statement for Signature of the Independent Investigator
	I assure that I will abide by the above principles and responsibilities of this Agreement in accordance with 45 CFR 46, as amended. Signature: _________________________ Date: ________ Name: _________________________Title: ___________ Office Address: _______________________ Phone: _________________________
2.	Institutional Official and IRB Chair Signatures
	The institution cited below is in possession of an OPRR-approved Assurance applicable to this project (enter Assurance number). The IRB and institution agree to be cognizant of the contents of this Agreement and to act in concert with all its requirements, in addition to those of its own applicable OPRR-approved Assurance. A copy of the current IRB membership roster is attached.
	Institutional Official _______________________: _______________________: _______________________: _______________________: _______________________: _______________________: _______________________: _______________________:	SIGNATURE NAME TITLE INSTITUTION ADDRESS DATE PHONE	IRB Chairperson :_____________________ :_____________________ :_____________________ :_____________________ :_____________________ :_____________________ :_____________________ :_____________________

	HHS Approving Official
	This agreement complies with the requirements of Part 46, Title 45 of the Code of Federal Regulations and is only valid for the named independent investigator and research activities of the specified award.
	Unless extended by OPRR, this Agreement expires upon termination of this DHHS award. This Agreement must be renegotiated with OPRR upon competing renewal of this award, when and as requested.
	Signature:____________________________________Date:______________________
	Name: __________________________________________ Title: ___________________________________________ Address: ________________________________________ Phone: __________________________________________ Agreement Number: ___________________

MEMBER NAME FIRST M.I. LAST	HIGHEST DEGREES EARNED	PRIMARY SCIENTIFIC OR NONSCIENTIFIC SPECIALTY	AFFILIATION WITH INSTITUTION ABOVE? (YES/N0)	ADDRESS AND PHONE NUMBER FOR CHAIRPERSON ONLY
*				IRB CHAIR NAME: ADDRESS: PHONE: FAX: E-MAIL: SIGNATURE:___________________________________ NOTE: Each IRB shall include at lease one member whose primary concerns are in NONSCIENTIFIC areas, as well as one member who is NOT OTHERWISE AFFILIATED with this institution. Please review 45 CFR 46.107 for other IRB membership requirements.








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