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41. Coordination of OSP and RIO for Investigator Access to Funds

The OSP and the RIO (on behalf of the IRB) coordinate efforts to ensure that research involving human subjects is not initiated without prior IRB approval. However, situations arise in which investigators require access to funds that have been awarded by a sponsor or to inform the sponsor of IRB acknowledgement for research activities.

Federal regulations (45 CFR 46.118) recognize that certain types of applications for grants, cooperative agreements, or contracts may be submitted to departments or agencies with the knowledge that human subjects may or will be involved within the period of support, but definite plans for the involvement of human subjects may not be set forth in the grant application or proposal. According to §46.118 these applications need not be reviewed by an IRB before an award may be made.

Before involving human subjects in sponsored research, PIs may require access to funds to complete activities such as

  • hiring research team members to assist with finalizing the research plan;
  • providing salary support while preparing the IRB application and supplemental materials;
  • purchasing instruments or other research materials; or
  • completing prior animal studies or other non-human subject research activities.

This coordination of effort between the two Offices must be initiated by the PI and involves one of two mechanisms.

1.      For grants or contracts already awarded to the institution: The RIO acknowledges to OSP the investigator's need to access research funds and specifies the framework in which such access may occur.

2.      For grants or contracts not yet awarded to the institution but for which the sponsor is requesting IRB approval: The RIO acknowledges to the sponsor (via OSP) of the need for the funds to be awarded at the institutional level.

These two mechanisms are administrative functions involving the investigator, RIO, and OSP which do NOT require the PI to complete an IRB protocol application.

Investigator Requests for Access to Funds

The following information is required for the RIO to evaluate PI requests for access to funds. (The information may be submitted as a memorandum or via email.)

1.      name, departmental affiliation, and email for the PI;

2.      title of grant or funded activity;

3.      name of sponsor or funding agency;

4.      rationale for why the investigators are unable to submit an IRB protocol at the time of the request but require access to the funds;

5.      specification in weeks or months of the time frame for the PI to complete tasks that do not involve human subjects (including end-date);

6.      description of the tasks to be completed during the specified time frame;

7.      explicit statement that the tasks to be undertaken during the specified time frame will not involve human subjects;

8.      copy of the approved grant, with budget; and

9.      copy of authorization from the sponsor releasing funds to the University, or copy of the request from the granting agency for authorization to release funds to the institution.

A RIO program manager will administratively review each PI request and will confirm the request complies with this policy. Following confirmation, the program manager will send an email to ospadmin@unr.edu and the PI. The email will acknowledge either the investigator's need to access funds for the specified period of time, or for the funds to be awarded for the completion of tasks prior to the involvement of involve human subjects.

Note: To facilitate processing by OSP, IRB Program Managers may wish to reference the PI's name and departmental affiliation in the subject line of the email.

Sample Email Acknowledgement: Investigator's Access to Funds

Date:

Name of principal investigator:

Departmental affiliation of principal investigator:

Title of grant, cooperative agreement, or contract:

Name of funding agency:

Re: Acknowledgement for investigator's access to sponsor's funds prior to IRB submission

The Research Integrity Office administratively acknowledges circumstances requiring the above-named PI to access funds provided by Sponsor to allow the researchers to define plans for the involvement of human subjects in research supported by these funds, and to prepare and submit the required documentation for IRB review and approval.

No human subjects may be involved in any project supported by these awards until a protocol has been reviewed and approved by the IRB, in accordance with UNR IRB policies and procedures. The investigator's access to funds is limited from today's date through [expiration date].

Sample E-mail Acknowledgement: Awarding of Funds

Date:

Name of principal investigator:

Departmental affiliation of principal investigator:

Title of grant, cooperative agreement, or contract:

Name of funding agency:

Re: Acknowledgement of research lacking definite plans for the involvement of human subjects

The Research Integrity Office administratively acknowledges circumstances requiring the awarding of funds to the University of Nevada, Reno on behalf of the above-named PI to allow her or him to define plans for the involvement of human subjects in research supported by these funds, and to prepare and submit the required documentation for IRB review and approval.

No human subjects may be involved in any project supported by these awards until a protocol application has been reviewed and approved by the IRB, in accordance with University policy.

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