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:
HIPAA, GCP, and COI can all be accessed on the RASCAL website.
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 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.
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 the new 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.”
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 can be completed online. It is estimated that the length of time to complete this requirement is 5 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.
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.
On March 1, 2006 the IRB implemented a new education training requirement for all investigators and research staff involved in human subjects research with minors. The new training involved the completion of the "Research with Minors" module within the Collaborative IRB Training Initiative (CITI) program. Approval for any protocol that involves children as subjects is contingent upon receipt of documentation that the "Research with Minors" module has been completed by the individuals engaged in the research. Please note that completion of this training is mandatory for individuals engage in any research with minors. The CITI program is a comprehensive education and training program that is utilized by many institutions and is comprised of online modules addressing various human research topics. The procedures for accessing and documenting completion of the required module have recently been revised by CITI.
CITI administrators have estimated that the process of accessing, reviewing and completing the module will take about 20 minutes. Individuals who are interested in reviewing additional modules in the CITI system, whether Biomedical or Behavioral, are encouraged to do so by selecting Group 1 or Group 2, respectively, via the “Change Group” link. CITI will provide documentation of completion of both the required module and optional modules to the IRB office.
If you have any questions, please contact Brenda Ruotolo, Associate Director, CU IRB, by telephone at 212.342.1218 or by email at firstname.lastname@example.org.
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.