Beginning October 1, 2006, the Human Investigation Committee (HIC) will increase its fees for initial review of industry-sponsored studies from $1,500 to $1,800. The HIC has not had an increase in fees since May 2001. The increase is necessary to keep pace with increasing administrative costs related to IRB review of protocols. During the past several years, most IRBs have had to increase their staffing and membership to review and manage research protocols in a timely manner while maintaining high standards of ethical review and protection of human participants in research. In addition, institutions have developed training programs for all key personnel involved in human participant research.

At WSU, we have added the following positions in the HIC office in order to ensure compliance with regulations (including HIPAA) and to provide necessary services for investigators:

Education Coordinator
Regulatory Compliance Coordinator/HIPAA Compliance Officer
Adverse Event/Unexpected Event Coordinator

We have also recently added a Pre-review Coordinator who will review HIC applications before they are submitted, providing suggestions for corrections and revisions in advance of the committee meeting. This service is available without an additional charge.

Fortunately, for-profit companies have acknowledged these institutional responsibilities and have been willing to compensate institutions for expenses related to their IRB programs. Contracts with these sponsors have designated additional funding for IRBs for the purpose of protecting human participants involved in their research.

In the continuing evaluation of how to maintain an appropriate program at WSU and to keep our commitments to the general public and the sponsors of research, WSU has developed a policy to charge for HIC review. These funds are used to support the total program for protecting human participants in research. That includes the review of the original protocol to the IRB, the monitoring of the research activities during the time that the research is active, a training program for investigators and all key personnel, and a compliance program to document that the institution is meeting its commitments to the general public and to sponsors.

Effective October 1, 2006, a direct cost fee of $1,800 will be assessed to each research protocol submitted to the HIC from for-profit companies (pharmaceutical companies, biotechnology companies, manufactures of investigational devices, for profit start-up companies, etc.). The fee will not be charged for HIC review of research supported by federal, state, or local governments, foundations, associations, or for projects supported through intramural funds. The HIC will begin to charge for annual continuations in October 2007. This continuation fee of $500 will be assessed for protocols that were initially approved from October 1, 2006 forward, but will not apply to studies beginning prior to October 2006.

The following conditions apply as they relate to the implementation of this increased fee:

1. The fee will increase from $1,500 to $1,800 beginning October 1, 2006.

2. The HIC will begin to charge a continuation fee of $500 beginning October 1, 2007, for all studies initially approved on or after October 1, 2006.

3. The fee is a mandatory fee that is assigned for the review of all research protocols involving human participants at WSU and its affiliated health care institutions. The fee will be a direct charge to all grants and contracts from for-profit companies that propose to use human subjects in research protocols.

4. The initial fee is an up-front cost of starting the research project and is not refundable if the project is not initiated at WSU. The payment is for the review of the human participant research and is not contingent upon approval of the research project by the HIC.

5. The fee assignments for HIC review and management of research protocols, and communication of the fee assignment to the industry sponsor will occur on the front end of the study budget calculations. This implies that the principal investigator, or the person(s) responsible in developing the study budget will have the responsibility to inform the appropriate personnel of the study sponsor if these charges. In addition, investigators or their designees will have the responsibility to convey to the sponsor that payment of the fees will be necessary before HIC approval memos will be issued by the HIC and before the study can be initiated.

6. Sponsored Program Administration (SPA) will have the responsibility to verify that the HIC fees are included as a direct cost in any human subject research project proposed to be supported by a for-profit company. This verification will occur before the grant application or contract proposal is submitted to the sponsor.

7. While the fee for HIC review will be assessed at the time the protocol is submitted to the HIC, the investigator will have up until the protocol is approved to authorize payment of the HIC fee. The HIC will not release the final approval memo to the faculty member until the principal investigator (or his/her designee) has authorized the transfer of the fee.

8. While the revised policy will be implemented October 1, 2006, there may be certain contracts that WSU has recently negotiated that do not include the revised fees. While certain companies may be willing to provide the additional HIC fees, the HIC will not require them to do so. However, after an initial three-month period in which exceptions to the revised fee will be automatically waived, sponsors and investigators should not expect the institution to waive the fee for HIC review.

9. Requests to be exempted from the requirement should be submitted to Francis LeVeque, DDS, Chair, Human Investigation Committee at 101 E. Alexandrine, Detroit, MI 48201 or email to fleveque@med.wayne.edu.

If you have any questions regarding the revised HIC fees, please contact the Human Investigation Committee (577-1628).