From: Tim [mailto:sparklin@umbc.edu]
Sent: Monday, July 2, 2018 4:49 PM
To: Business Managers/Research Administrators Group listserv <business_resource_group-group@umbc.edu>
Subject: From the [business_resource_group-group] Kuali COI Module Implementation

 Dear Colleagues,  

 As part of UMBC’s transitioning from the research management format in PeopleSoft to the cloud-based Kuali system, the Office of the Vice President for Research is ready to implement  the next steps of the Kuali COI module.

 Investigators who are considered “Key Persons” in grant proposal submissions to funding agencies (e.g., PHS or NSF) are required to disclose any potential significant financial conflicts of interests to ensure there is no reasonable perception of a conflict in the design, conduct, or reporting of research.  While the current UMBC policies have not changed; the procedure to disclose has changed.

 What This Means For You? 

 Kuali COI replaces the Office of Research Protections and Compliance (ORPC) paper document/email notification disclosure routing process. This means all COI disclosures will now be handle via the Kuali COI module. Many faculty colleagues have already been using the Kuali COI module during the transition to using Kuali Proposal Development.

 Effective July 9^th 2018, the Kuali COI module will be updated. For those already using Kuali COI, you will see the  COI certification question in Kuali Proposal Development has been eliminated.  All COI related questions are now housed in the Kuali COI module. The Annual Disclosure status under Key personnel in Proposal Development must state “Up to Date”. If the Annual Disclosure says “Update Needed” or “Expired”, the identified Key Personnel must go into the COI module to complete or update their COI answers before the Office of Sponsored Programs (OSP) can approve the proposal.  Kuali will send an automated email notification to any named Key Person once the proposal has been saved in Kuali. At a minimum, all “Key Persons” named on a proposal will be required to answer  5 core COI questions.

The ORPC will work with faculty who have submitted paper COI disclosures for previously submitted proposals (via the PeopleSoft Finance process) to ensure that all disclosures are current and up to date.

Also note, if you plan to submit a proposal to a Public Health Services (PHS) entity [e.g., NIH], the requirement to take the CITI FCOI training is still in effect.

 Next Steps

 Self-Study Option:  Go to COI Training page to read the Kuali COI User Guide - a Power Point presentation that includes step-by-step instructions and screen shots.  This should give you enough information to understand, certify, route, COI disclosures via workflow.

Still not comfortable?  Then sign up for one of the multiple in-person training options that are offered monthly.

 Please keep an eye out for information regarding Phase Two, which will focus on OSP functionality (awards, negotiations, sub-awards), but will also  include information and modules of interest to the broader UMBC community using Kuali (protocols - IRB & IACUC, reporting, unfunded agreements – MTAs, NDAs, DUAs, etc.).  

 For more detailed information regarding Kuali, please visit the OVPR Kuali page at http://research.umbc.edu/kuali-research-at-umbc/.

The Department of Health and Human Services (HHS) published a final rule today to delay the general compliance effective date to update the federal regulations that protect the rights and welfare of human research participants (AKA the 2018 Requirements). These updates seek to modernize, strengthen and make more effective the federal policies for the protection of human research participants. The effective date for compliance with these requirements is January 21, 2019.  

The UMBC Institutional Review Board (IRB), along with the Office of Research Protections and Compliance (ORPC) will continue preparations for the 2018 Requirements implementation. The IRB and ORPC are revising procedures and forms for UMBC investigators to comply with the January 21, 2019 effective date. 

Common Rule changes include:

• ·       What is NOT considered human subjects research
• ·       New exemption & revised exemption categories
• ·       Continuing review changes for minimal risk studies
• ·       Single IRB review for multi-site research (effective January 20, 2020)
• ·       Consent form changes

The ORPC has created a document that describes how the 2018 Requirements impacts human subjects​ ​research​  at UMBC.  Staff from the ORPC will provide educational outreach (via the IRB website, the ORPC myUMBC page as well as in-person education sessions) to provide investigators guidance about procedures and application processes and forms.

To summarize, the compliance schedule to adhere to the 2018 Requirements is as follow:

Previously approved ongoing protocols, prior to January 21, 2019

 UMBC protocols will continue to follow all pre- 2018 Requirements - current IRB protocol processes -for the duration of the approved study. The ORPC will verify with investigators the intended end-point of a study to ensure close out occurs on a timely basis.

Protocols approved on or after January 21, 2019

 UMBC protocols will follow the 2018 Requirements for all protocols submitted to or approved by the IRB on or after 01/21/2019. IRB website guidance, procedures and application forms will contain updates prior to the 2018-2019 winter break to use for new protocol submissions.

Investigators – please take note of the following:

 EXISTING FULL BOARD PROTOCOLS

Protocols reviewed by the full board and are open to enrollment or still in an intervention phase will see the fewest changes under the 2018 Requirements. At the time of the next renewal that occurs after 01/21/2019, the ORPC will request you to update the waiver and consent form to meet the new requirements.

EXISTING EXPEDITED PROTOCOLS

Most studies that originally expedited by the IRB under the pre- 2018 Requirements will now be eligible for less frequent review beginning on 01/21/2019. At the time of the next renewal that occurs after 01/21/2019, the ORPC will request you to update the waiver and consent form to meet the new requirements.

EXISTING EXEMPT PROTOCOLS

There will be no changes to these protocols. If you have an exempt study that has ended, it is important to close the study with the IRB.

For more information, please contact the ORPC staff at compliance@umbc.edu or 5-2737.

Dear Colleagues, on August 23 UMBC/OSP will be hosting an NCURA workshop called "Building Blocks for Research Administration". This full-day workshop (9 AM to 4 PM) will provide you with knowledge, strategies, and tools needed to manage sponsored projects effectively.  The discussion will cover the federal regulations upon which institutional compliance is based;  the administrative concepts of proposal submission; costing issues; the concept of effort; post-award management; project closeout; compliance and audits.  

Learning Objectives: 

• Provide participants with a broad overview of the various aspects of Research Administration;
• Overview of pre-award processes;
• Gather basic understanding of post-award activities such as allowability of costs, effort reporting, cost sharing, closeout, and audits.    

This workshop is dedicated to everyone who has a basic understanding of the management of sponsored projects. Participants will benefit from a better understanding of the various concepts of Research Administration.

The registration form is available at https://ncuraregionii.org/wp-content/uploads/2018/06/UMBC-Building-Blocks-WORKSHOP-FORM.pdf

We are moving from our temporary location in the RAC to our newly remodeled digs on the 4th floor of the admin building next week!

Beginning Monday, June 18 we will have no access to phones and limited access to email. We expect to be fully functioning by Wednesday, June 20. The best way to reach us is by email.

Come by to see our new makeover!

We are moving from our temporary location in the RAC to our newly remodeled digs on the ^4th floor of the admin building next week!

Beginning Monday, June 18 we will have no access to phones and limited access to email. We expect to be fully functioning by Wednesday, June 20. The best way to reach us is by email.

Come by to see our new makeover!

I am not sure if we have any of these proposals going in but just in case wanted to make sure you are aware of these requirements.

Stan

NIH Science Education Partnership Award (SEPA)(R25)

PAR-17-339

Applicants must provide plans to address these two topics. 

1.    Recruitment Plan to Enhance Diversity.  Applications lacking a diversity recruitment plan will not be reviewed.

2.    Training in the Responsible Conduct of Research.  Applications lacking a plan for instruction in responsible conduct of research will not be reviewed

Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. 

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended.  See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.    

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double

Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and mathematics   http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments.

o    For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment plan will not be reviewed.

1. Plan for Instruction in the Responsible Conduct of Research.  

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). 
• The plan must address the five, required instructional components outlined in the NIH policy:
  • 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups
  • NOTE: a plan with only on-line instruction is not acceptable
  • 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics;
  • 3) Faculty Participation - the role of the program faculty in the instruction;
  • 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and
  • 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also  NOT-OD-10-019.
  • The plan should be appropriate and reasonable for the nature and duration of the proposed program.
  • All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.