Standard Operating Procedures of the Institutional Review Board

XI. Cooperative Research


Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human participants and for complying with this policy. With the approval of the Department or Agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.

 

When UNF agrees to provide oversight to external investigators, they effectively become UNF PIs for the purposes of this study or studies and are expected to meet UNF standards. Among other things this means that they must comply with the same training requirements (e.g., CITI training) as UNF investigators, unless they come from an institution that has similar requirements that we accept.

 

Two types of external agreements may be used by the IRB: Individual Investigator Agreements (IIA) and IRB Authorization Agreements (IAA). Each serves a different purpose and is used in different situations.



A. Individual Investigator Agreement


Occasionally, UNF may be asked to provide IRB review for outside investigators who are not affiliated with UNF nor with an institution that has an IRB. This would typically involve studies based at UNF in which the outside investigator is engaged in human subjects research. In general we would not extend IRB oversight to research by outside investigators in which UNF is not otherwise engaged. Thus, outside investigators must seek a UNF faculty or staff member to serve as the co-PI for the proposed research.

 

This agreement is used for two types of individual external investigators:

  1. Independent Individual Investigators – those who act outside any business, institutional, or organizational role they may have. For this type of investigator agreement, the following documents should be included and placed in the UNF IRB record:
  • External Investigator’s full name and credentials, mailing address, phone number and e-mail address if this information is not included on the curriculum vitae;
  • UNF IRB Study number and title;
  • Name and degree(s) of UNF PI; and
  • Letter or e-mail indicating that the IRB accepts oversight of the external investigator and the use of this type of agreement, that the curriculum vitae of the investigator is on file with IRB, and that research ethics training requirements have been met for this individual.
  1. Institutional Individual Investigators – those who act as agents of a business, agency, institution, or organization for which they work and which does not have a federalwide assurance. For this type of investigator agreement, the following should be included and placed in the UNF IRB record:  
  • Written confirmation from appropriate authority of organization where external investigator works confirming that this research is permitted;
  • Name, mailing address, and phone/fax of business, agency, institution, or organization s/he is affiliated with;
  • Letter or e-mail indicating that the IRB accepts oversight of the external investigator and the use of this type of agreement, that the curriculum vitae of the investigator is on file with IRB, and that Research Ethics training requirements have been met for this individual;
  • External Investigator’s full name and credentials, mailing address, phone number and e-mail address if that information is not provided on the curriculum vitae;
  • UNF IRB study number and title; and
  • Name and degree(s) of UNF PI

Regarding the timing of final IRB approval in relation to execution of the agreement, the IRB has the discretion to either provide contingent approval for the study pending the finalization of the agreement (necessitates return for final approval) or provide final approval for the study noting the need for completion of the agreement to proceed with research activities involving the external



B. IRB Authorization Agreements


When two institutions, both holding FWAs, are engaged in the same research study, it may be appropriate for one institution to rely on the IRB of another institution for review and continuing oversight of that research (i.e. this would typically involve studies primarily based at one institution, with somewhat peripheral involvement by investigator(s) at the other). This type of agreement is executed between institutions to document the delegation of IRB oversight where Institution A is the one providing continuing oversight and Institution B is the one relying on the one providing continuing IRB oversight. These arrangements may be considered but cannot be forced on either collaborating institution. This agreement is used in three types of situations:

 

  1. UNF IRB relies on (i.e., defers to) the IRB of an external, assured institution

For this type of IAA, the following should be included in the UNF IRB record:

  • Letter or e-mail from an IRB administrator indicating the IRB has reviewed the protocol and has determined that an IAA is requested because the UNF IRB is willing to rely on the external IRB;
  • Name of engaged, external site;
  • FWA number and appropriate IRB name and registration number for engaged, external site;
  • UNF IRB study title and number;
  • External IRB study title and number;
  • Name and degree(s) of UNF PI;
  • Name and degree(s) of external PI;
  • Sponsor or funding agency and the award number; and
  • Full name, title, mailing address, phone number of Institutional Official at the external site. This would typically be the official who signed the FWA unless signature authority has been formally delegated to another. If applicable, include the name, address, and telephone number of the head of external IRB, who may want all agreements directed through him/her.

Special Note: Other institutions have different versions of this institutional authorization agreement and may want to use their version if their IRB has oversight

  1. The IRB of the external, assured institution relies on (i.e., defers to) UNF’s IRB.

For this type of institutional authorization agreement, the following should be included in the UNF IRB record:

  • Letter or e-mail from a UNF IRB administrator indicating the IRB has reviewed the protocol and has determined that an IAA is acceptable and that the UNF IRB will take oversight responsibility;
  • FWA number and appropriate IRB name for engaged, external site;
  • UNF IRB study title(s) and number(s);
  • External IRB study title(s) and number(s);
  • Name and degree(s) of UNF PI;
  • Name and degree(s) of external PI;
  • Sponsor or funding agency and the award number, if applicable;
  • Full name, title, mailing address, phone number, and e-mail of Institutional Official at the external site. If applicable, include the name, address, and telephone number of the head of external IRB, who may want all agreements directed through him/her.

The default is for an institutional authorization agreement limited to one study. However, multiple studies that involve a single, external investigator can be grouped into one agreement. This might occur when an external group essentially becomes an extension of a UNF-based research team in an on-going manner. Also a standing arrangement for an external site to rely on UNF IRB(s) for multiple, future studies can be established but requires the institutional official’s involvement in decision and appropriate wording of IAA.

  1. The external assured institution does not have their own IRB and needs to use UNF’s IRB(s) as the IRB of record in order to be engaged in the research.

For this type of institutional authorization agreement, the following should be included in the UNF IRB record:

  • Letter or e-mail indicating UNF IRB has reviewed the protocol and has determined that an IAA is appropriate and that the UNF IRB will take oversight responsibility;
  • Name of engaged, external site;
  • FWA number of engaged, external site;
  • UNF IRB study title(s) and number(s);
  • Name and degree(s) of UNF PI;
  • Name and degree(s) of external PI;
  • Sponsor or funding agency and the award number, if appropriate; and
  • Full name, title, mailing address, phone number, and e-mail of Institutional Official at the external site (must be same person who signed the FWA).

Regarding the timing of final IRB approval in relation to execution of the agreement (i.e. signed by both UNF and IO of external site), the IRB has the discretion to either provide contingent approval for the study pending the finalization of the agreement (necessitates return for final approval) or provide final approval for the study noting the need for completion of the agreement to proceed with research activities involving the external collaborator/site (documentation filed, but approval already granted).

 

For UNF, the Associate Vice President for Research has been formally designated as the institutional official with signature authority for these types of agreements.