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Rules and Regulations Are Not What Research is All About

by Sharon J. Glazer, MPH, Editor, Academics@Baystate newsletter | May 01, 2012
 

Baystate's Research Integrity Officer Anita Sarro, RN, MS, JD, is spreading the word that she is a resource for the ethical dimensions of research, not just the legal ones.

 

Anita Sarro, Research Integrity Officer, Wants to Take on a More Supportive Role, Rather Than Being Perceived Only as an Enforcer.


Helping Keep an Eye on the True Purpose of Research

Hot Topics for
Federal Grantees

A preview of Anita Sarro's presentation at Academic Week on May 16 at 9 am.


Financial Disclosure

On August 24, 2012, the definition of significant financial interest will change dramatically. Learn how Baystate is implementing the new federal regulations that affect applicants for federal grants.


Required Training

Researchers with any NSF and some NIH grants must document a minimum of 8 hours of CMEs in COI, authorship, human subjects research, peer review, and mentoring. Learn how Baystate meets this requirement, and how do address it in your applications.

"Sometimes researchers see regulations as an end in themselves, rather than as an attempt to embrace the ethical principles that need to be included in every research protocol," states Sarro.


"From the minute investigators design their research, they have to show how it will benefit people and how to create the study to minimize risks. That’s where the ethical and legal principles and the regulatory requirements come in."


Ms. Sarro is available to work one-on-one with researchers to help interpret policies such as interactions with industry and conflict of interest, and to assist them in demonstrating Baystate's compliance with federal grant requirements. She has already made presentations to department chairs and the Physician Leadership Team around specific legal, ethical or regulatory principles.


In addition, she is presenting a talk on new regulations for federal grants at Academic Week (see "Hot Topics" sidebar).


Engendering Public Trust While Contributing to Scientific Knowledge

Ms. Sarro admits that initially she didn't grasp the entire scope of her role, and her focus was around policy research, development, and implementation for Human Research Protection Program, Sponsored Programs Administration, and the Institutional Animal Care and Use Committee. According to Sarro, there was neither an interactions policy nor a fully-compliant misconduct policy in place until she developed them. "Misconduct, interactions with pharma, conflict of interest – that’s the core of what most research integrity offices pay attention to."


Now, she has a deeper appreciation of all the dimensions of her role, saying it's not " just working in the deep background and once in a while emerging for high profile misconduct cases."


Purview is Institution-wide and Across All Scholarly Activity

"[Research Integrity] is about doing the best medicine we can, the best science we can, so we can further the health of the people we serve.”

—Anita Sarro, RN, MS, JD
Research Integrity Officer

Ms. Sarro feels that the designation 'Research' Integrity Office may be too narrow, because Academic Affairs encompasses both research and education.


Sarro now wants to bring her energy and focus to the education side. She has come to believe that every educational opportunity is a chance to incorporate ethical principles.


"How can we insinuate the knowledge and appreciation of ethical principles into research and other scholarly activity in a way that won’t be perceived as 'another thing you’re asking me to do'?" she asks. Instead of imposing from above, she believes that it's better to work from the bottom up—to collaborate with educators to identify resources to build into educational programs.


Sarro can help program directors, the Office of Continuing Education, and others who are putting together grand rounds and CME programs to look more deliberately at ethical aspects when creating their objectives.


Vision is to Strengthen and Perpetuate Research Integrity Office

"Baystate never had this function before," says Sarro. " Other than the IRB, there was no place to look at some very difficult issues." She would like to see the Research Integrity Office become stronger and be a more valuable contributor to the larger research picture.


The Research Integrity Officer position is part-time—she also serves as a risk manager. But she would like to see the position evolve to full-time.


"One reason I'm coming forward a little more is that this function can’t die when I retire. I'd like to see this position evolve into a full-time position."

This article was published in the May 2012 Academics@Baystate newsletter.

 
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