Research Staff Profile -- Margaret Burggren

Enabling the Responsible Conduct of Research

The Office of Research Affairs, a subunit of the Research Area, provides services and training that promote external sponsorship. The Office also ensures that research is conducted in compliance with state and federal regulations. As Associate Director of Research Affairs, Margaret Burggren is currently involved in restructuring the Human Research Protection Office (HRPO) and expanding the Responsible Conduct in Research (RCR) program. As the University continues to grow as a research extensive institution, there has been an increase in the quantity and complexity of research involving human subjects, and Marg has led the way in building services and processes to help researchers move more easily through the compliance review process. Research Affairs expects to start using a new electronic system for both human subject and animal use protocols in the coming months.

Marg and her colleagues in Research Affairs are excited about the prospect of a new compliance management system. "This is a big change for the campus researchers," Marg explained. "Part of the reason we are moving toward a new system is to provide some efficiency and flexibility to the application process. If you are doing research that is biomedical in nature, for example, the electronic application will lead you through a series of questions that are specific to that type of research protocol." Those in the social, behavioral and educational research areas will have forms that exclude the extensive biomedical questions historically present in human subject materials. “Because individual researcher’s protocols tend to be similar" Marg said, "once their initial protocol has been entered in the system, researchers will be able to clone a protocol and just make the changes necessary for future submissions. It will be a great time saver for both the researcher and for those who review the protocol."

Much of Marg's efforts have gone into streamlining the work of the Institutional Review Board (IRB), a federally mandated board with twelve members that must review and approve the highest risk projects. Marg and several faculty serve on the board which is also required to have one member of the community who is not affiliated with the university and one non-scientist. Marg noted, "It is imperative to have a lay person and a non-scientist on the board as they are quickly able to recognize when information is too scientific for the typical human subject volunteer therefore ensuring that nobody gets involved in a project that they do not completely understand." Marg also works with IRB's from other institutions such as the Five Colleges , Bay State Medical, and Hartford Hospital when UMass researchers are collaborating with staff at one of these institutions.

The IRB, under the experienced leadership of the Chair, Priscilla Clarkson, oversees approximately two hundred protocols per year. Each protocol involving human subjects must be updated annually. In addition to the central IRB which is responsible for higher risk protocols, UMass also has several local boards that review protocols for their department. Marg will be working with both the central board and the local boards in anticipating the new application procedures. Various guidelines and commonly asked questions are currently available online with plans to expand the listings as needed to assist in the design of research that involves human subject protection.

Apart from overseeing the Human Research Protection Office (HRPO), Marg is also involved in working with the Research Council to develop Responsible Conduct in Research policies and a curriculum for the campus. "Ethics in research is more than just compliance with human and animal regulations," noted Marg, "there are many other issues such as authorship, data management, conflict of interest and research misconduct that we as a campus need to be responsible for especially when it comes to educating graduate students and new researchers." Marg and her colleagues are working on bringing an online training course to campus on the responsible conduct of research. “As with the on-line human subject training, we anticipate this to be a helpful addition to the curriculum for a number of classes, especially those involving research methods,” notes Marg.

With twenty-five years of experience in the Research Area, Marg has found working with the IRB and the HRPO to be a new and exciting challenge over the past three years. "It is not always clear-cut as to when a project requires human subject review and when it does not fit within the parameters of the federal regulations. I spend a lot of time studying the rules and analyzing different research scenarios to determine the appropriate level of review. This has probably been the most challenging aspect of the job to date.” Marg welcomes questions, even those that are not clear-cut. Contact Margaret Burggren or Nancy Swett, Assistant for Human Subjects Research (413-545-3428). Feedback is also welcome regarding a Responsible Conduct in Research curriculum and the office would gladly work with volunteers to try out the new online protocol system.