Research Compliance Requirements

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:

Register their UNI in Columbia University’s Research Administration System (RASCAL)
Submit a new Conflict of Interest (COI) Disclosure Statement annually NOTE: Must submit after 7/23/12
Complete the Financial Conflicts of Interest and Research for PHS Researchers Course (TC1450)
Complete the Health Insurance Portability and Accountability Act (HIPAA) Training Course (TC0019)
Complete the Good Clinical Practices (GCP) Training Course every three years (TC0087)
Complete the Effort Reporting Policy and Process Course (TC0068)
Disclose all sponsored or reimbursed travel within 30 days

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:

Verify and/or update personal information at MyColumbia (CU Human Resources System)
Obtain and NIH eRA Commons ID and verify and/or update their personal information in eRA Commons
Complete the Training in Research with Minors Course
Comply with the Mandatory NIH Public Access to Publications Resulting from NIH-Funded Research (PMCIDs) Policy NOTE: Library now offers assistance.

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.

RASCAL UNI Registration

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:

Directions

Go to https://www.rascal.columbia.edu
On the top drop-down menu on the right side of the screen, choose “My Rascal”.
In the fields below that, enter your Columbia University UNI and password. The password to use is the same password you use to access your Columbia e-mail.
You will then be asked to complete some administrative/demographic information about yourself.
After, you will be prompted to complete your first “Conflict of Interest” statement.
After complete these steps, you will be able to login in RASCAL and complete the necessary HIPAA and GCP courses.

Conflict of Interest

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.

Directions

Go to https://www.rascal.columbia.edu
Log in with your Columbia University UNI and password
Click “Conflict of Interest” tab on the top menu of the page
Click “Start New Disclosure”
Answer all questions and thn click the "Certify" button

Complete the “Financial Conflicts of Interest and Research for PHS Researchers” Course

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.

Directions

Go to https://www.rascal.columbia.edu
Log in with your Columbia University UNI and password
Click “Training Center”
Click “Course Listings”
Scroll down to “TC1450 – Financial Conflicts of Interest and Research for PHS Researchers”
Read through the required course material by clicking “Take Course”
Take the quiz by clicking “Take Test”

HIPAA

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.

Directions

Go to https://www.rascal.columbia.edu
Click the “Training Center” tab on the left menu
Log in with your Columbia University UNI and password
Click “Course Listings”
Click on the course listing entitled “TC0019 HIPAA: Health Insurance Portability and Accountability Act Training Course”
Choose “Take Course” from the left menu
Once you have completed the online course, choose “Take Test” and score 80% or better to pass. Note: You can re-take the test if you do not pass the first time.
To print proof of your HIPAA certification at any time in the future, select “View Certificate Test History” and select “Generate Certificate”

Good Clinical Practices

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.

Directions

Go to https://www.rascal.columbia.edu
Click the “Training Center” tab on the left menu
Log in with your Columbia University UNI and password
Click “Course Listings”
Click on the course listing entitled “TC0087 Human Subjects Protection Training”
Choose “Take Course” from the left menu
NOTE: There is no longer a Rascal test for this course. Rather, the course includes short tests following each module.
To print proof of your GCP certification at any time in the future, select “View Certificate Test History” and select “Generate Certificate”

Effort Reporting Policy

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.

Directions

Go to https://www.rascal.columbia.edu
Click the “Training Center” tab on the left menu
Log in with your Columbia University UNI and password
Click “Course Listings”
Click on the course listing entitled “TC0068 Effort Reporting Training”
Choose “Take Course” from the left menu
NOTE: There is no test associated with this course. To receive credit, the system must register that you reviewed all slides in the course. After successful completion of the course, your grade will be represented as “100.”
Be sure to print a copy of the last screen and retain it for your records.

Disclose All Sponsored or Reimbursed Travel within 30 Days

Investigators must disclose all sponsored or reimbursed travel within 30 days of travel by sending an e-mail to TravelUpdate@columbia.edu, except:

travel funded through the University, or
travel reimbursed or sponsored by a Federal, state or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S. institution of higher education.

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 research-compliance@columbia.edu.

Verifying and/or Updating Personal Information at MyColumbia

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.”

Directions

Go to: https://my.columbia.edu
At the top left of the page, click on the link "Log in with your Columbia UNI"
You will be sent to the log in screen where you will log in with your Columbia UNI and password. You will then be sent back to the My Columbia page.
Back on the My Columbia page, click on the 3rd tab at the top "Faculty & Staff"
Scroll down 1/2 page and on the left under the blue heading "Faculty & Staff Self-Service" click on the 3rd link, "Update your Personal Information".
You will be sent to the PeopleSoft page where you should verify all information, including your work mailing address and phone numbers. There are buttons to click to change addresses, phone numbers, degrees, etc. Please go into these and verify/update information as needed. Changes made on this screen will be automatically updated on the InfoEd face page within 2-3 days.

Verifying and/or Updating Personal Information in NIH eRA Commons

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.

Directions

Go to the NIH eRA Commons home page at: https://commons.era.nih.gov/commons/index.jsp
On the left side of the page, login with your eRA Commons ID and password. NOTE: You must have an eRA Commons ID if you are submitting a grant OR if you are named as Key Personnel on a grant submission. If you have forgotten your password, click on the “Forgot password?” link under the login boxes)
Click on the “Personal Profile” tab at the top of the page
Go through each subcategory under the Personal Profile tab (Personal Information, Race/Ethnicity, Employments, Reviewer Address, Residential Address, Degrees, Publications, etc.), verifying that all information is correct and that ALL mandatory fields (with a red * asterisk) have been completed.

Mandatory NIH Public Access to Publications Resulting from NIH-Funded Research (PMCIDs) Policy

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.

Details

The NIH Public Access Policy applies to all peer-reviewed articles that arise, in whole or in part, from direct costs funded by NIH, or from NIH staff, that are accepted for publication on or after April 7, 2008.
Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.
PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal articles. Its content is publicly accessible and integrated with other databases (see: http://www.pubmedcentral.nih.gov/).
The final, peer-reviewed manuscript includes all graphics and supplemental materials that are associated with the article.
Effective May 25, 2008, anyone submitting an application, proposal or 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. This policy includes applications submitted to the NIH for the May 25, 2008 due date and subsequent due dates.

Compliance

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.

Directions

To begin the process of complying with the new requirement, visit http://publicaccess.nih.gov
Follow the instructions for submitting your journal articles resulting from NIH-funded research

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 hs-library@columbia.edu or Dina Matsoukas, Head of Reference and Education Coordinator, directly at km2056@columbia.edu, 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
Email: PublicAccess@nih.gov
Website: http://publicaccess.nih.gov