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)
Complete the Health Insurance Portability and Accountability Act (HIPAA) Training Course
Complete a Good Clinical Practices (GCP) Training Course
Submit a new Conflict of Interest (COI) Disclosure Statement annually
Obtain an NIH eRA Commons ID and verify and/or update their personal information in the eRA Commons
Verify and/or update personal information at MyColumbia (CU Human Resources System)

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.

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: If you are in the School of Nursing do not have an eRA Commons ID, please contact Kristine Kulage as soon as possible. If you are in another School or Department at Columbia University, PLEASE CONTACT YOUR PROJECT OFFICER in the Sponsored Projects Office).
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.

Verifying and/or Updating Personal Information at MyColumbia

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.”

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.

RASCAL 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 can be completed online. It is estimated that the length of time to complete this requirement is 5 minutes.

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 “YES” to the question, “Would you like to file a Conflict of Interest Disclosure Statement?”
Answer the 14 “Yes/No” questions, as applicable, and click the “Submit” button

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”

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”

Training in Research with Minors

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.

Directions

Go to: http://www6.miami.edu/bb/sunyreg/
Select “The “Core” CITI Course http://jaguar.ir.miami.edu/%7Ecitireg/page2core.htm”.
Select “Columbia University” from the drop-down menu in the “Participating Institutions:” box.
Create your username and password, following the CITI instructions, enter your name and email address(es), then “submit”.
Complete all required fields on the CITI Registration page, then “submit”.
On the “Select Curriculum – Columbia University” page, select “yes” under item #2, “Do you conduct research with children?”. [Do not make any selection under item #1.] Then “submit”.
On the “Select your institution or organization” page, you may select “yes” or “no” as applicable to your individual situation.
On the “Learner’s Menu” page, select “Enter” in the “My Courses” section. [You may want to review the “Columbia University Instructions page” although it is not required. The link is on the “Learner’s Menu” page.]
Select “Introduction” under the Required Modules. This describes the Belmont Report and provides links to the Report. Review the information provided, then take the quiz by selecting “Take the Quiz….”
After you take the quiz:
a) If you passed the quiz, select “Go to the next module – Columbia University”.
b) If you did not pass the quiz, select “View this module again” to re-take the quiz.
Review the information provided in the “Research Involving Minors” section, then take the quiz by selecting “Take the Quiz….”.
After you take the quiz:
a) If you passed the quiz, select “Go to the next module – Columbia University.
b) If you did not pass the quiz, select “View this module again” to re-take the quiz.
Review the information provided in the “Columbia University” section, then select “Go to the Main Menu”.
The IRB Office will be notified electronically of your successful completion of the module. In addition, the IRB Office may download a list of individuals who have completed the module, as needed.

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 blr2102@columbia.edu.

NIH Public Access to Publications Resulting from NIH-Funded Research – This Requirement is Now Mandatory

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
Please contact Kristine Kulage, Director of Research Resources, should you require assistance
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