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Institutional Review Board
Teachers College, Columbia University
Teachers College
Columbia University

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THE IRB OFFICE IS LOCATED INSIDE THE OFFICE OF INSTITUTIONAL STUDIES AT 407D RUSSELL HALL.

IRB Electronic and Paper Submissions
The Teachers College Institutional Review Board (IRB) currently requires an electronic and a paper-based version of each IRB application to be submitted to our office for review.  The paper-based application should include all documents and forms as well as original signatures.  The electronic version of the application does not need to include signatures. 

Electronic submissions
(as a single PDF file for each application) should be sent via email to Sarah Hersch at: hersch@tc.edu

Paper-based submissions (with original signatures and all supporting documents and forms) should be either

Delivered to:

The IRB Office within the Office of Institutional Studies, Room 407D Russell Hall

Or sent to:

Teachers College, IRB

525 West 120th Street, Box 151

New York, NY 10027

For New Study Applications, no matter what the category of Review, we will require the following:

  • one (1) paper-based Application with original signatures, all supporting documentation [including relevant Informed Consent, Participants Rights and Assent for Minors Forms, translations, surveys, questionnaires, instruments, scales, interview scripts, permission letters, recruitment documents, text or materials], and a copy of researchers' certificates or proof of Human Subjects Research training unless training has been done through or affiliated with the Teachers College, Columbia University CITI online training program (see Training and Certification for more information). Please note: any individual who has not yet been a Principal Investigator on a TC research study is required to take the CITI training.
  • one (1) single PDF document containing the Application and all of the above supporting documentation with the following exceptions: 
    • NO translations of Informed Consent, Participants Rights and Assent for Minors Forms  
    • NO permission letters from institutions or organizations
    • NO Certificate/s or proof of having taken Human Subjects Research training
    • The PDF version does not need signatures

For Changes/Modifications to a previously approved protocol, we will require a MEMO (submitted with faculty sponsor's signature if Principal Investigator is a student, and sent electronically as a PDF file to Sarah Hersch at: hersch@tc.edu) that includes the following information:

  • PI name, project title and protocol number
  • Faculty advisor's name, if applicable
  • Reference specific sections of the original protocol and summarize the contents of those sections and the changes you wish to make and why the changes are necessary.
  • Attach new Informed Consent/Participant's Rights Forms, surveys instruments, recruitment materials, and/or IRB approvals/permissions from cooperating institutions if new institutions have been added, as applicable.

For Continuing Review Applications we will require the following:

  • one (1) paper-based Application with original signature/s and new supporting documentation [Informed Consent, Participants Rights and Assent for Minors Forms (including translations), surveys, questionnaires, instruments, scales or interview scripts, permission letters, recruitment documents or flyers] so they can be stamped with the updated expiration date when the Continuing Review is approved.  We also require copies of the previously IRB-stamped and approved Consent Forms, Approval letter/s, and copies of the last two (2) Consent Forms as signed by subjects.  After your study receives Continuing Review Approval, you will be sent a new Approval letter and new IRB-stamped and approved supporting documentation [Informed Consent, Participants Rights and Assent for Minors Forms, etc.] for distribution to your potential participants.
  • one (1) single PDF document containing the Continuing Review Application and all of the above supporting documentation with the following exceptions: 
    • NO translations of Informed Consent, Participants Rights and Assent for Minors Forms 
    • NO permission letters from institutions or organizations

Important Resource: 
  • COMMON ERRORS GUIDE FOR FIRST TIME APPLICANTS: To better serve first-time applicants for IRB review, OSP has published the first ever Common Errors Guide at Teachers College. Using samples taken from IRB applications over the last three years, the guide addresses how investigators can avoid recurring pitfalls in the area of human subjects research.

All current versions of Microsoft should be capable of using PDF-making software in order to produce a single PDF document.  The college also has Adobe Acrobat Professional software for making PDF documents, available in the Computer Labs located in Rooms 345 Macy and 242 Horace Mann.

PLEASE NOTE:  There are no IRB materials available in the office.  All information and materials are available on our website.  Please contact the Research Compliance Manager, Sarah Hersch [hersch@tc.edu or T: 212-678-4105] if you have questions about this or any other IRB matter.

HIPAA

The Health Insurance Portability & Accountability Act (HIPAA) contains provisions that protect the privacy of medical records, including records reviewed or created in the context of research. The new provisions took effect on April 14, 2003. The information below details the actions TC is taking to ensure compliance with HIPAA and provides some guidance to help you determine if your research is subject to HIPAA, and the actions to take if it does.


Institutional Compliance with HIPAA:

1. HIPAA requires that all institutions appoint a privacy committee to review research protocols for compliance with HIPAA privacy mandates. Effective March 24, 2003, Acting Dean Aaron Pallas appointed the Teachers College Institutional Review Board (IRB) as our Privacy Committee for HIPAA purposes.

2. New, revised IRB application forms addressing HIPAA compliance are available online.

Determining if HIPAA applies to your research:

3. Determining whether or not HIPAA applies to you depends first and foremost on where you are doing your data collection. HIPAA will apply if you are collecting personal health information (PHI) in or from a HIPAA-covered entity. HIPAA-covered entities include:

  • Hospitals, including teaching hospitals and medical research centers
  • Private medical practices or facilities
  • Mental heath care practices or facilities
  • Social service agencies that provide either medical or mental health assistance (for example, hospices, welfare program offices, drug and alcohol treatment centers, nursing homes, rehabilitation facilities)
  • Insurance companies and HMOs

Are you collecting information in or from a HIPAA-covered entity?

4. If you answer “yes” to the above, will you be collecting or reviewing private, identifiable medical information, such as diagnosis, treatment, medical history, etc?

5. If you answer “yes” to the above, will the identities of the individuals from whom you are collecting data be known to you?

If the answer to all three of the above is “yes,” then your research is subject to HIPAA. In practical terms, this means you must do one of two things: 1) obtain consent from research subjects to create, use and disclose Private Health Information (this consent is a separate form and is given to participants in addition to your previously approved Informed Consent Document) or 2) request a waiver of HIPAA authorization.

If you desire to obtain a HIPAA waiver, to determine that your study qualifies for such a waiver the following conditions must be met:

  • The research involves no more than minimal risk to the subjects
  • The waiver will not adversely affect the rights and welfare of the subjects
  • The research could not practicably be conducted without the waiver
  • The research could not practicably be conducted without access to and use of the PHI
  • The use or disclosure of the PHI involves no more than minimal risk to the privacy of the subjects as a result of:

o    An adequate plan to protect the PHI from improper use and disclosure;

o    An adequate plan to destroy any identifiers contained in the PHI at the earliest opportunity consistent with the research;

o    Adequate written assurances that the PHI will not be reused or re-disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted; and

o    Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Please note: In general, "identifiers" means information about an individual or his or her relatives or employer that alone or in combination with other information could identify the individual.

Again, it's important to recognize that most research conducted under TC's auspices will not be subject to HIPAA. The two questions to ask are 1) where am I collecting this data? and 2) are there identifiers linking the data to an individual? Also bear in mind that just because your research is exempt for IRB purposes doesn't mean it's exempt from HIPAA. The most common example of IRB exempt research that is subject to HIPAA is a review of medical or health care records that was exempt under category 4): Review of archival data.

 

ANNOUNCEMENT

Proposed Changes to the Common Rule

To improve rules protecting human research subjects and to enhance effectiveness of oversight

The U.S. Department of Health and Human Services (HHS) announced on July 22, 2011 that the federal government is considering making changes to the regulations which have been in place since 1991 and are often referred to as the Common Rule. 

The changes under consideration, designed to strengthen protections for human research subjects and keep pace with current challenges in a number of ways, can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register.    

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at only a single site.  Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects.

The government is seeking the public's input on an array of issues related to the ethics, safety, and oversight of human research, and public input will be considered by HHS as it develops new proposed rules, which will also be made public for comment.

Comment is sought on the following:

  • Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  • Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  • Updating the forms and processes used for informed consent.
  • Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  • Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  • Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  • Providing uniform guidance on federal regulations.

To view the ANPRM, please visit http://www.hhs.gov/ohrp.

To submit a comment, visit http://www.regulations.gov, enter the above ID number, and click on "Submit a Comment."

For additional information about the changes under consideration, visit
http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.