Investigator Agreement by by654321

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									                                         Investigator Agreement

Name of Institution with the Federalwide Assurance (FWA): CHRISTUS Santa Rosa Health Care
Applicable FWA #: 00000486
Institutional Review Board of Record:
Investigator's Name:

TERMS:

I understand that this Agreement will be required annually for each Principal Investigator Involved in
Human Subject Research within CHRISTUS Santa Rosa Health Care. Agreements are active as long as
an active Protocol is open. A new Agreement will be required if time lapses with no active protocols
under a given Principal Investigators name.

COMPLIANCE:

I understand and hereby accept the responsibility to comply with the standards and requirements to
protect the rights and welfare of human subjects involved in research conducted under this agreement.

I will comply with all other National, State, or local laws or regulations that may provide additional
protection for human subjects.

In conducting research involving FDA-regulated products, I will comply with all applicable FDA
regulations and fulfill all Investigator responsibilities (or investigator-sponsor responsibilities, where
appropriate), including those described at 21 CFR 312 and 812.

I acknowledge that I am primarily responsible for safeguarding the rights and welfare of each research
subject, and that the subject's rights and welfare must take precedence over the goals and requirements of
research.

I will not enroll subjects in research under this Assurance prior to its review and approval of this protocol
by the IRB.

I will assure advertisements for subject participation at CHRISTUS Santa Rosa Health Care are approved
by the IRB and CHRISTUS Santa Rosa Health Care.

INFORMED CONSENT:

I will obtain, document and maintain records of informed consent for each subject or the subject's legally
authorized representative as required under DHHS and FDA regulations (or other international or national
equivalent) and stipulated by the IRB.

No human being will be involved as a research subject unless legally effective informed consent of the
subject has been obtained.

Informed consent documents will be placed in both the patients inpatient and outpatient medical record.

In addition, all patients are given a description of
     the expected benefits
     the potential discomforts and risks

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Investigator's Name : _____________________________


       all patients asked to participate in a research project are given a description of alternative services
        that might also prove advantageous to them
       all patients asked to participate in a research project are given a full explanation of the procedures
        to be followed, especially those that are experimental in nature
       all patients asked to participate in a research project are told that they may refuse to participate,
        and that their refusal will not compromise their access to services.
       Patients and, when appropriate, their families are informed about the outcomes of care, including
        unanticipated outcomes.

I am aware that consent contains 3 elements: information, comprehension and voluntariness. Therefore,
consent will be provided in an organized manner, sensitive to time and considerate to subject’s questions
and inquiries.

I will assure consent is obtained in a voluntary manner, free of coercion and undue influence.

I will assess the subjects preferred language and assure that subjects will be consented in their language
with a copy of the correct language consent placed in their medical record (both inpatient and outpatient).

REPORTING TO THE IRB:

I will abide by all determinations of the IRB designated in this Assurance and will accept the final
authority and decisions of the IRB, including but not limited to directives to terminate participation in
designated research activities. The CHRISTUS Santa Rosa Research Projects Office will abide by the
determinations of the IRB designated for this study.

I will report promptly to the IRB any proposed changes in the research conducted under this Assurance. I
will not initiate changes in the research without prior IRB review and approval, except where necessary to
eliminate apparent immediate hazards to subjects.

I will report immediately to the IRB any unanticipated problems involving risks to subjects or others in
research covered under this Assurance.

I acknowledge and agree to cooperate in the IRB's responsibility for initial and continuing review, record
keeping, reporting,and certification. I will provide all information requested by the IRB in a timely
fashion and will forward these reports to the CHRISTUS Santa Rosa Research Projects Office.

I will maintain a file of documents related to the conduct of this study. Documentation includes:
     A signed final protocol, with approved and dated protocol amendments
     Receipt and disposition documents indicating drug supplies
     Advertisements for subject participation
     IRB approvals, correspondence (adverse events), and reports
     Sponsor/monitor contacts, visit log and correspondence

I understand that the CHRISTUS Santa Rosa Research Projects Office shall have the authority to suspend
or terminate approval of the research project if not being conducted in accordance with the decision,
conditions and requirements set forth by the Institutional Review Board, CHRISTUS Santa Rosa Health
Care, the Food and Drug Administration and the Department of Health and Human Services (DHHS).




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Investigator's Name : _____________________________


REPORTING TO THE CHRISTUS RESEARCH PROJECTS OFFICE

All Status/Final Reports including the approval from the IRB of record and the report submitted.

All Changes in study staff that will have involvement with CHRISTUS Santa Rosa Health Care
patients.

All Protocol changes that will impact departments.

Per the requirements of our FWA and our CSRHC’s agreements with WIRB and UTHSCSA IRB (see
attachment), the following will be reported. It would be in the best of the Investigator and/or the
study for the Principal Investigator to self-report regarding 2 and 3.

1. All serious/unexpected (events) involving risks to CHRISTUS Santa Rosa Health Care patients.
2. Serious or continuing noncompliance with Federal Regulations or IRB requirements
3. Suspension or termination of the IRB approval

EDUCATION:

I have reviewed the following documents:
 The Belmont Report http://www.fda.gov/oc/ohrt/IRBS/belmont.html
 The U.S. Department of Health and Human Services (DHHS) regulation for the protection of human
    subjects at 45 CFR 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
 The Federalwide Assurance http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm
 Relevant Institutional Policies and Procedures for the protection of human subjects

I will complete any educational training required by the IRB of Record and/or CHRISTUS Santa Rosa
Research Projects Office prior to initiating research covered under this agreement.

PRINCIPAL INVESTIGATOR:

The proposed research project will be conducted by me or under my close supervision at CHRISTUS
Santa Rosa Health Care.

All proposed research projects will be conducted in accordance with the protocol submitted to and
approved by the IRB and the CHRISTUS Santa Rosa Health Care Research Projects Office.

I meet the requirements of membership and privileges of CHRISTUS Santa Rosa Health Care as
indicated in the Medical Staff By-laws and rules and regulations.

I will assure that co-investigators and research associates (residents, research nurses, research associates)
meet institutional requirements throughout the study.

I will assure a copy of the Drug/Device sheet will be completed for each subject enrolled in the study.
Copies of the sheet will be placed in the patient’s inpatient and outpatient medical record.

I will notify the CHRISTUS Santa Rosa Health Care Research Projects Office of any visits conducted by
study monitors, auditors, or sponsors. A written summary of the visit will be submitted to the Office.




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Investigator's Name : _____________________________


CONFIDENTIALITY:

The confidentiality of all personally identifiable information (PHI) collected will be protected, and staff
and collaborators will be trained on policies and procedures for ensuring confidentiality of this
information.

I will abide by the Privacy Rule regarding Protected Health Information including use of CHRISTUS
Forms as applicable:
Form No. 2061 - Request for De-Identified Information.
Form No. 2071 - Limited Data Set Request and Data Use Agreement
Form No. 3021 – Accounting of Disclosures of Protected Health Information

I hereby give assurance that I will comply with the regulations of CHRISTUS Santa Rosa Health Care,
the IRB of Record, the Food and Drug Administration and the Department of Health and Human Services
(DHHS) for the protection of human subjects with respect to the conduct of research.




_______________________________                                    ________________________________
Principal Investigator Signature                                   Principal Investigator's Printed Name


_______________________________
Date




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