RIO Roundtable 

Presented by Cristy McGoff From Harvard Univeristy

Special Guest Presenters:  John Carfora, Michelle Benson, Jennifer Ryan and Mary Walsh.

The RIO Roundtable began out of the need for a collective discussion and sharing of resources by those who are research integrity officers at their institutional or share these duties of the RIO in the New England region. It is open for those in these roles or those who engage in research integrity -related activities and/or charged with the duties of the RIO in the investigation of research misconduct at their institution. We are hoping to further enhance the RIO Roundtable as a place to share proactive approaches to policies and procedures that may foster a culture of research integrity at their home institutions. **The RIO Roundtable sessions are open to all who are attending the USM Research Integrity Symposium**

How to Communicate the Importance of Research Integrity to Your Institutional Leadership, presented by John Carfora

What strategies can we help introduce and enhance to assure that our colleges and universities have adequate systems in-place for managing, monitoring and overseeing research and scholarly integrity, the Responsible Conduct of Research and the Responsible Conduct of Scholarly Activity, along with larger compliance-related themes?

How might we better educate and align our efforts with a range of college/university constituents – and senior academic leaders in particular – around organizational ethics, research integrity, RCR and compliance-related issues?

Finally, how do we now if the system(s) we have developed are actually effective?

One University’s Approach to Promoting a Culture of Research Integrity, presented by Michelle Benson from Columbia University and Jennifer Ryan  from Harvard Medical School

Irreproducibility, research misconduct, and bias are serious issues that can discredit science, and, in some cases, damage the reputations of researchers and their institutions. Funders have responded to these concerns by, among other things, requiring Responsible Conduct of Research (RCR) training and implementing new “Rigor and Reproducibility” requirements. However, promoting a culture of research integrity requires additional institutional support at all stages of the research lifecycle. Columbia University implemented the Research and Data Integrity (ReaDI) Program in 2014 to enhance data management and research integrity for Columbia researchers at any level.
This interactive session will give a brief introduction of the ReaDI Program, including a “behind-the-scenes” look at what has and has not worked, followed by a discussion of how other institutions are addressing these issues, including Harvard Medical School’s efforts to build a new program. At the conclusion of the session, participants will have models and resources to help guide them in considering how to promote a culture of research integrity at their own institutions.

Learning Objectives: (1) Understand possible strategies for promoting a culture of research integrity; (2) Learn what resources may be available to researchers to support reproducible and robust results including resources both within and outside own institution; (3) Learn ways to effectively communicate with researchers on the practices that can affect research integrity

General Forensic Data Analysis: Initiation of an academic forensic data review at Harvard Medical School, presented by Mary Walsh from Harvard Medical School

Forensic data review and analysis in the academic setting is a unique process that is often associated with misconduct Inquiry(ies) and Investigation(s) at the institutional level. Although a fundamental element of the discussion and decision making process during the course of academic misconduct proceedings, there is no standardized approach in how we as investigators/research integrity officials approach this endeavor. To address this knowledge gap, the forensic team of the Office for Academic and Research Integrity (ARI) at Harvard Medical School have been working to create consistent workflows and identify best practices for how to initiate, track, analyze, present and report out on work product and findings specific to data analysis during the course of the academic forensic data review cycle. We propose to lead a discussion with the attendees around:

  1. The Sequestration process: documenting the who, what, where, how and when essential data have been collected
  2. Tracking: What are we as investigators/staff accessing and why are we accessing it?
  3. Analysis: How do we analyze data (especially if it is proprietary), primary/Raw data vs. everything else, and the importance of metadata
  4. Presenting your findings: Distilling core issues from the details
  5. Formal record of assessments: Capturing all of the above in a singular format

Within this structure, we note that every academic forensic review is different, as our researchers across our local communities are engaged in a wide variety of scientific and biomedical exploration in many fields. However, we hope that by preparing our own best practices on how we forensically assess research, we are mirroring the very concepts we are encouraging our scientific community to embody. Namely, a transparent assessment process which all parties have access to and can understand, that engenders thoughtful discussion around critical decisions concerning potential research misconduct. This has been an ongoing initiative in our office and we look forward to further discussions in the broader research integrity community.

ABC’s for IACUCs & IBCs: FRAMEWORKS FOR COMPLIANCE™ 

Presented by the Massachusetts Society for Medical Research

ABC’s for IACUCs & IBCs: FRAMEWORKS FOR COMPLIANCE™ is an MSMR training program designed and developed for the IACUCs and IBCs. Those who will profit most from this training program are IACUC and IBC administrators and staff, committee members (including non-affiliated members), research administrators, compliance staff, occupational health and safety staff, vivarium staff and attending veterinarians.

The program comprises a series of modules and exercises developed by collaborations of MSMR volunteer experts with long experience in IACUC and IBC structure, operation, mission and program management. The program is delivered on-site at an MSMR member facility which also hosts employees from other MSMR members for the training. An important goal is bringing representatives of the IACUC and the IBC together, to better understand their shared mission and one another’s work.

ABC’s for IACUCs & IBCs: FRAMEWORKS FOR COMPLIANCE™ gives a detailed overview of the laws, regulations and policies that govern the work of these two important oversight committees. Presentations are intermingled with pertinent team exercises and sample protocols. This program is designed to help meet the requirement stated in the Guide for the Care and Use of Laboratory Animals 8th edition, 2011, that states “All personnel involved with the care and use of animals must be adequately educated, trained, and/or qualified in basic principles of laboratory animal science to help ensure high-quality science and animal well-being”. It will also address USDA/APHIS/AC Policy 15.

Both the IACUC and the IBC are committed to ensure the protection of the research staff, the animal husbandry staff, veterinarians and all others involved in research or who may have contact with or exposure to biohazardous agents. Those completing the program will:

  1. Have a clear overview of the laws, regulations, and policies that govern the human care and use of laboratory animals
  2. Learn about the NIH OBA, the contents of the NIH Guidelines for Research Involving Recombinant DNA Molecules, and the history of IBCs and develop an understanding of the range of responsibilities that IBCs have under the NIH Guidelines
  3. Examine the relationship of IBC and IACUCs in terms of their respective roles and responsibilities
  4. Discuss obstacles and other issues that both committees experience in meeting their ongoing research efforts and objectives
  5. Review the key components of an integrated program through case studies and protocol review; Engage in discussion with colleagues to share ideas about best practices, resources, innovative approaches, and collaborations.

Government Procurement & Export Controls 

Presented by Danielle Conway the Dean of University of Maine School of Law and Scott A. Felder Attorney at Law, Wiley Rein LLP

The first part of the workshop will introduce attendees to government procurement. Specifically, the session will address the regulatory requirements for Department of Defense contracts such as those found in the Department of Defense Federal Acquisition Regulation Supplement (DFARS). A portion of the presentation will be reserved to answering questions attendees have both in the area of DOD contracts and procurement law in general.

The second part of the workshop will introduce attendees to the Arms Export Control Act and the Export Administration Act and their export control regimes, specifically The International Traffic in Arms Regulations (ITARS), The Export Administration Regulations (EAR), The Office of Foreign Assets Control Regulations (OFAC) and their corresponding sanctions and sanction programs.  Attendees will be guided through a discussion of these export control laws and regulations, the importance of an export management and compliance program, and the risks and burdens associated with the dissemination of technical data and technology.   Specifically, the session will address the implications of sharing technical data and technology and the best practices for handling and safeguarding such information as well as controlling and managing dissemination of it.

Mock IRB

Presented Carol Mickelson & Sara Tenorio from FHI 360 (Family Health International)

The purpose of the MOCK IRB interactive session is to focus on the process involved in the initial review of human subject research submitted to an Institutional Review Board (IRB). Throughout this workshop presenters will provide instruction and guidance in the application of the federal regulations for the Protection of Human Research Subjects (45 CFR 46). Presented topics will include an Overview of the IRB Review Processes: Criteria for Approval, Assessment of Risks / Benefits and Required Elements of Consent.

For the Mock IRB’s, attendees will be assigned to small groups (representing an IRB) and each IRB is given the task of reviewing a research study. A final discussion will include the identification of ethical issues and recommendations to meet the criteria for approval. A Review Checklist, including the required elements of consent, will be provided to guide the review process and document the IRB determination.

MOCK IRB I: Review Process involving a Social Behavioral Research

A social behavioral protocol and informed consent (in this study a minor assent and parental permission form) that purposefully contains several ethical issues will be reviewed.

MOCK IRB II: Review Process involving Biomedical Research

A biomedical protocol and informed consent form that purposefully contains several ethical issues will be reviewed.

Important Note: Since the MOCK IRB reviews are interactive sessions, workshop attendees are requested to review, both social behavioral and biomedical study materials, before coming to the workshop. These materials will be provided to attendees in time for this requested pre-review.