GUIDELINES CONCERNING PARTICIPATION BY NON-AFFILIATED INVESTIGATORS IN IUPUI/CLARIAN RESEARCH PROTOCOLS

These guidelines pertain to investigators or practitioners (hereafter referred to as “investigator”) not employed or otherwise affiliated with Indiana University-Purdue University, Indianapolis (IUPUI) or Clarian Health Partners (Clarian).  

IUPUI and Clarian embrace and promote the principle that all research is to be conducted in a manner that complies with applicable laws, regulations and ethical standards.  The IRBs at IUPUI and Clarian expect that all research adheres to the same ethical principles and regulatory oversight whether administered at IUPUI/Clarian or at a non-affiliated location and/or by a non-affiliated investigator.  In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human participants.

When a researcher is aware of or reasonably anticipates that an investigator not employed or otherwise affiliated with IUPUI/Clarian (e.g., their local physician) will be playing a role in the design, conduct, or reporting of the research, including persons obtaining consent and handling identifiable information, or will be making independent decisions about the inclusion or exclusion of participants in the study AND that non-affiliated investigator does not have local IRB approval for the protocol at their facility, steps should be included to address this scenario within the body of the protocol and in the summary safeguard statement before submission of the protocol to the IRB.  When the participation of a non-affiliated investigator is not anticipated prior to submission of the protocol to the IRB, the research will require IRB approval by means of an amendment to the study which may require full board IRB review before the non-affiliated investigator may participate in protocol-specific procedures.  The amendment must specifically describe what procedures will be performed by the non-affiliated investigator.

A specific, written agreement must be established in advance with any non-affiliated investigator (a sample is provided in Attachment A).  The purpose of the agreement is to establish a record of the non-affiliated investigator’s acknowledgement of complete understanding of the protocol as well as the specific obligations of his/her participation.  This agreement must be executed for each non-affiliated investigator who will be performing protocol-specific procedures (see above).  In situations where a single non-affiliated investigator will be performing different study interventions on more than one subject, an agreement (and amendment) must be filed for each subject. The responsibility for obtaining this agreement lies with the principal investigator.  It is the responsibility of the principal investigator to 1) provide a copy of the informed consent and protocol to the non-affiliated investigator, 2) explain non-affiliated investigator’s expectations, 3) obtain written agreement with the non-affiliated investigator prior to allowing him/her to conduct any part of the protocol, and 4) obtain IRB approval of this agreement prior to allowing the non-affiliated investigator to conduct any part of the protocol.

Requirements of the study sponsor more stringent than those enumerated above will supercede institutional guidelines (e.g., if the sponsor does not allow protocol procedures to be conducted away from the institution, those restrictions will apply).

For those studies involving non-affiliated investigators which were in existence prior to the enactment of these guidelines, at the time of continuing review, the circumstances involving the non-affiliated investigator must be explained and the procedures performed by the investigator(s) must be delineated.

These guidelines will apply to studies which qualify for full board review.  Studies that qualify for exempt or expedited status will be reviewed on a case-by-case basis to determine if these guidelines should apply.

ATTACHMENT A

Non-Affiliated Investigator Agreement

Name of Non-Affiliated Investigator (hereafter known as “Investigator”):      	

Name of IUPUI/Clarian Principal Investigator (hereafter known as “PI”):      	

Name of Institution Providing IRB Oversight: Indiana University-Purdue University, Indianapolis/Clarian Health Partners (IUPUI/Clarian)

OHRP Federalwide Assurance Number:      	

IUPUI/Clarian IRB Study #:      	 

Protocol-Specific Procedures to be Performed by the Non-Affiliated Investigator:      	
     
(1)	The above-named Investigator has reviewed the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, the U.S. Department of Health and Human Services (DHHS) regulations for the protection of human subjects at 45 CFR 46, the Food and Drug Administration (FDA) regulations for the protection of human subjects at 21 CFR 50 (if applicable), the Assurance referenced above, and the relevant institutional policies and procedures for the protection of human subjects.

(2)	The Investigator understands and hereby accepts the responsibility to comply with the standards and requirements stipulated in the above documents and to protect the rights and welfare of human subjects involved in research conducted under this Agreement.

(3)	The Investigator will comply with all other National, State, or local laws or regulations that may provide additional protection for human subjects.

(4)	The Investigator will abide by all determinations of the IUPUI/Clarian IRB designated under the above Assurance and will accept the final authority and decisions of the IUPUI/Clarian IRB, including but not limited to directives to terminate participation in designated research activities.

(5)	The Investigator will complete any training required by the IUPUI/Clarian IRB prior to initiating research covered under this Agreement.

(6)	The Investigator will report promptly to the PI who will then report to the IUPUI/Clarian IRB proposed changes in the research conducted under this Agreement.  The investigator will not initiate changes in the research without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.

(7)	The Investigator will report immediately to the PI who will immediately report to the IUPUI/Clarian IRB any unanticipated problems in research covered under this Agreement that involve risks to subjects or others.

(8)	The Investigator will seek, document, and maintain records of informed consent from the subject or the subject’s legally authorized representative as required under HHS regulations (or other international or national equivalent) and stipulated by the IUPUI/Clarian IRB (if applicable).

(9)	The Investigator will report any significant new findings to subjects.

(10)	The Investigator acknowledges and agrees to cooperate with the PI in IUPUI/Clarian’s responsibility for initial and continuing review, record keeping, reporting, and certification.  The Investigator will provide all information requested by the PI and IUPUI/Clarian IRB in a timely fashion.

(11)	In conducting research involving FDA-regulated products, the investigator 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 (if applicable).

(12)	The investigator will not enroll subjects in research under this Agreement or perform any protocol specific procedures prior to its review and approval by the IUPUI/Clarian IRB.

(13)	Emergency medical care may be delivered without IRB review and approval to the extent permitted under applicable Federal regulations and State law.  However, such medical care may not be included as part of Federally-supported research.

(14)	This Agreement does not preclude the investigator from taking part in research not covered under the Agreement.

(15)	The investigator acknowledges that her/his primary responsibility is to safeguard the rights and welfare of research subjects, and that the subjects’ rights and welfare must take precedence over the goals and requirements of the research.

Signatures:

Non-Affiliated Investigator:	Date:	 

IUPUI/Clarian Principal Investigator (PI):	Date:	

IUPUI/Clarian Institutional Official:	Date: