In order to conduct or be involved in any research activities at Columbia University School of Nursing, all faculty, staff, and students are required to:
In addition, depending on your role research projects, the research funder, or the type of research activities you will be involved in, you may additionally be required to:
All Research Compliance Training Courses can all be accessed through RASCAL website. If you are uncertain as to which compliance course(s) you are required to complete, please visit the Columbia University Medical Center Research Compliance Training Finder.
NOTE: You will be unable to participate in research activities until you have completed the HIPAA and GCP Course. In addition, any grant applications you are participating on will not be approved by the Grants & Contracts Office until you have completed the Financial Conflicts of Interest, HIPAA and GCP courses and have an up-to-date COI disclosure statement submitted. Finally, if you are named as a Key Personnel on a grant application, you must obtain an eRA Commons ID.
If you have a Columbia University UNI and password but have never logged into the RASCAL system, you will need to do this before you can complete HIPAA, CGP, or COI. In order to do this, please follow these steps:
A Columbia University Medical Center Faculty and/or Affiliated Hospital Staff Member is considered to have a Conflict of Interest (COI) when he, any of his Family, or any Associated Entity possesses a Financial Interest in an activity or Business which may have an inappropriate influence, or appear to have such an influence, on his activities as a member of the Faculty or Affiliated Hospital /Staff. Included in these responsibilities are all activities in which the Faculty or Affiliated Hospital Staff Member is engaged in the areas of teaching, research, patient care, or administration.
Completion of a new COI Disclosure Statement is required annually and is completed online. NOTE: If you have not updated your COI since 7/23/12, you are required to submit a new one immediately.
All Investigators must complete Rascal TC1450, “Financial Conflicts of Interest and Research for PHS Researchers.” This course fulfills the training requirement for Columbia University researchers who are funded by the U.S. Public Health Service (PHS) or who plan to apply for such funding. NOTE: PHS-funded researchers must read through the course material prior to completing the quiz. NOTE: Grant applications will NOT be submitted by SPA if any investigators have NOT completed TC1450.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandates that Columbia University Medical Center conduct training for all its employees and affiliates who access, use, manage, control, disclose, and/or release patient Protected Health Information (PHI). The purpose of this training module is to educate CUMC faculty and staff engaged in human subjects research on the HIPAA privacy rule requirements and to help insure that these research activities are compliant with the HIPAA requirements.
Completion of the HIPAA training module and course (with a score of 80% or better) is a one-time requirement and can be taken online. It is estimated that the length of time to complete this requirement is 30-45 minutes.
All faculty, staff, and students conducting or involved in research in epidemiology, behavioral sciences, or patient-oriented research at Columbia University must take an online course in Good Clinical Practices (GCP) to ensure that they have a working knowledge of the principles and ethics associated with good clinical practices.
Completion of the GCP training module and course (with a score of 80% or better) is a one-time requirement and can be taken online. It is estimated that the length of time to complete this requirement is 30-45 minutes.
Effort reporting is the federally-mandated process by which the salary charged to a sponsored project is certified as being reasonable in relation to the effort expended on that project. All Officers of Instruction and Officers of Research (except for postdoctoral Officers of Research) who receive sponsored project funding or apply effort to any sponsored projects are required to certify their own effort.
First time effort self-certifiers must take a mandatory one-time 20-30 minute online course prior to the completion of his/her own individual annual effort certification. The course is designed to familiarize individuals with Federal regulations and Columbia University policies and procedures that govern effort reporting and certification. Individuals who do not complete this course cannot certify their own time.
Investigators must disclose all sponsored or reimbursed travel within 30 days of travel by sending an e-mail to TravelUpdate@columbia.edu, except:
The full policy on “Reporting Sponsored Travel” can be found at: http://www.columbia.edu/cu/compliance/docs/conflict_interest/PHS_COI/PHS_Travel.html
If you have any questions about types of travel that this policy would apply to, please contact TravelUpdate@columbia.edu or the Office of Research Compliance and training at firstname.lastname@example.org.
In the InfoEd grant submission system, many fields are pre-populated based on personal information in the Columbia University Human Resources PeopleSoft system. Some pre-populated information is showing up incorrectly on the SF 424 R&R face page because information needs to be updated in PeopleSoft. In order to correct this information on the grant face page, Principal Investigators need to verify and/or update their personal information in “My Columbia.”
With the transition to electronic grant submissions, it has become mandatory in the grants.gov system that ALL investigators, as well as ALL faculty and staff (e.g., Co-Investigators, Project Directors, etc.) who are named as “Key Personnel” on grant applications, obtain an eRA Commons ID. In addition, it is essential that all individuals verify and update their “Personal Information” stored in the eRA Commons.
NOTE: Empty mandatory fields and incomplete/inaccurate information in the eRA Commons WILL cause delays in grant submissions, warning messages, and even error messages. To assure a smooth grant submission through grants.gov, please be sure to verify and/or update your Personal Information the eRA Commons prior to submitting a grant.
In accordance with Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008), the NIH voluntary Public Access Policy (NOT-OD-05-022) is now mandatory. The law states:
The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.
Please be sure that, as a Principal Investigator, you and your NIH-funded project are in full compliance. This mandatory policy directly affects the procedures of the Office of Research Resources because Effective May 25, 2008, anyone submitting a Grant Application, Proposal or Annual Progress Report to the NIH must include the PMC or NIH Manuscript Submission reference number when citing applicable articles that arise from their NIH funded research.
Compliance with this Policy is a statutory requirement and a term and condition of the grant award and cooperative agreement, in accordance with the NIH Grants Policy Statement For contracts, NIH includes this requirement in all R&D solicitations and awards under Section H, Special Contract Requirements, in accordance with the Uniform Contract Format.
NEW: The CUMC library has applied for publisher status which means that they can now assist faculty members with obtaining the required PMCIDs for their publications resulting from NIH-funded projects. Library staff will also be able to tell you if a particular journal has started the process or if they need to start the process for you. Although there isn't a formal procedure for requesting help with PMCIDs, faculty can e-mail email@example.com or Dina Matsoukas, Head of Reference and Education Coordinator, directly at firstname.lastname@example.org, to request PMCID-related services at this time. They are very responsive to these requests and can also consult on the best workflow practices for gathering PMCID info using citation management tools, such as Endnote. For more information, visit: http://library.cumc.columbia.edu/nih-public-access-policy-compliance
Send questions concerning this Notice or other aspects of the NIH Public Access Policy to:
Office of Extramural Research
National Institutes of Health
1 Center Drive, Room 144
Bethesda, MD 20892-0152