NCURA, the National Council of University Research Administrators, held its 53rd Annual Conference in Washington, D.C., from November 7 to 9. One of several sessions related to AAHRPP accreditation was a discussion group moderated by AAHRPP’s chief education and evaluation officer, Dr. Peter Vasilenko. The topic was integrating the Office of Sponsored Programs into the Human Research Protection Program (HRPP).
Even before the formal presentations started, the participants had a lively discussion about the necessity for good two-way communication between the IRB and the Office of Sponsored Programs. Sponsored programs must learn of IRB approval before they can release funds connected to research that involves human participants. The IRB needs to know about specific provisions that are negotiated in the contracts, in particular the arrangements for payment of treatment expenses for research-related injuries so that the consent process and document are approved with appropriate language.
Dr. Vasilenko presented the AAHRPP Standards related to contracts and funding agreements and passed out copies of the AAHRPP Advance article entitled “Contract Provisions Help Protect Research Participants” and the newly released Tip Sheet 25 on “Provisions in Contracts and Funding Agreements.” These materials can be found on the AAHRPP Web site at http://advance.aahrpp.org/2011/11/contract-provisions-help-protect.html and http://www.aahrpp.org/Documents/D000310.PDF.
The first discussant, Amy Barelli, is the research process manager at Stanford University (an AAHRPP-accredited organization). She previously worked in the IRB office and understands the need for all parts of the HRPP, including sponsored programs and the IRB, to communicate. Ms. Barelli acknowledged Stanford’s long history of good communication among units but highlighted a current successful program she calls “HRPP Office Hours.” Once a month representatives from all units of the HRPP hold an open meeting where any researchers, staff, or administrators can come and ask questions. Since every HRPP unit attends, the answers are comprehensive, representing all points of view and special requirements of each unit. Another added benefit is that the individual units themselves learn about the others, which has fostered more communication, understanding, and cooperation. The HRPP Office Hours have become a popular and successful institution at Stanford, creating an excellent forum for communication at a very large university.
Another discussant from Stanford University, Caroline Jones, a contract and grants officer, talked about the Office of Sponsored Research’s process for incorporating AAHRPP language into contracts. Because Stanford has integrated the AAHRPP Standards into its contract templates, most of the time the officers are able to simply insert the appropriate paragraphs from their template into contracts under negotiation. When they receive some pushback about the exact language, they explain the conditions to the sponsor and negotiate modified language that both sides can agree to but that covers the general requirements of the AAHRPP Standards.
Lisa Benson, the director of research administration and sponsored programs at Connecticut Children’s Medical Center (another AAHRPP-accredited organization), also talked about her experience interacting with the IRB and making sure that contracts reflect the required AAHRPP language. In contrast to a very large organization, this smaller facility has sponsored programs staff who are situated near the IRB staff and have regular communications. Ms. Benson explained that she has inserted the AAHRPP required language into contracts with relatively little resistance.
Overall, this excellent and productive discussion demonstrated that offices of sponsored programs and IRBs can work together to apply the AAHRPP Standards to protect human research participants. Both very large and smaller organizations have reported success. Enhanced communication among units of the HRPP is one of the key changes that organizations attribute to accreditation.
Even before the formal presentations started, the participants had a lively discussion about the necessity for good two-way communication between the IRB and the Office of Sponsored Programs. Sponsored programs must learn of IRB approval before they can release funds connected to research that involves human participants. The IRB needs to know about specific provisions that are negotiated in the contracts, in particular the arrangements for payment of treatment expenses for research-related injuries so that the consent process and document are approved with appropriate language.
Dr. Vasilenko presented the AAHRPP Standards related to contracts and funding agreements and passed out copies of the AAHRPP Advance article entitled “Contract Provisions Help Protect Research Participants” and the newly released Tip Sheet 25 on “Provisions in Contracts and Funding Agreements.” These materials can be found on the AAHRPP Web site at http://advance.aahrpp.org/2011/11/contract-provisions-help-protect.html and http://www.aahrpp.org/Documents/D000310.PDF.
The first discussant, Amy Barelli, is the research process manager at Stanford University (an AAHRPP-accredited organization). She previously worked in the IRB office and understands the need for all parts of the HRPP, including sponsored programs and the IRB, to communicate. Ms. Barelli acknowledged Stanford’s long history of good communication among units but highlighted a current successful program she calls “HRPP Office Hours.” Once a month representatives from all units of the HRPP hold an open meeting where any researchers, staff, or administrators can come and ask questions. Since every HRPP unit attends, the answers are comprehensive, representing all points of view and special requirements of each unit. Another added benefit is that the individual units themselves learn about the others, which has fostered more communication, understanding, and cooperation. The HRPP Office Hours have become a popular and successful institution at Stanford, creating an excellent forum for communication at a very large university.
Another discussant from Stanford University, Caroline Jones, a contract and grants officer, talked about the Office of Sponsored Research’s process for incorporating AAHRPP language into contracts. Because Stanford has integrated the AAHRPP Standards into its contract templates, most of the time the officers are able to simply insert the appropriate paragraphs from their template into contracts under negotiation. When they receive some pushback about the exact language, they explain the conditions to the sponsor and negotiate modified language that both sides can agree to but that covers the general requirements of the AAHRPP Standards.
Lisa Benson, the director of research administration and sponsored programs at Connecticut Children’s Medical Center (another AAHRPP-accredited organization), also talked about her experience interacting with the IRB and making sure that contracts reflect the required AAHRPP language. In contrast to a very large organization, this smaller facility has sponsored programs staff who are situated near the IRB staff and have regular communications. Ms. Benson explained that she has inserted the AAHRPP required language into contracts with relatively little resistance.
Overall, this excellent and productive discussion demonstrated that offices of sponsored programs and IRBs can work together to apply the AAHRPP Standards to protect human research participants. Both very large and smaller organizations have reported success. Enhanced communication among units of the HRPP is one of the key changes that organizations attribute to accreditation.
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