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Columbia University Human Research Protection Program

Policy & Guidance Refresher

 

July 2014

Protocol Deviations and Violations

All deviations from and violations of Columbia IRB policies or IRB determinations, including departures from the requirement for adherence to the approved protocol, must be reported to the IRB.

• A protocol deviation is defined as a variation from the approved protocol for one subject or to address a temporary situation that is identified by the research team and approved by the IRB before implementation.

• A protocol violation is defined as a variation from the approved protocol that was implemented without prospective approval by the IRB (and was not implemented to avoid or minimize imminent harm*). Protocol violations may be considered as noncompliance with the federal regulations and institutional policies for the protection of human subjects. If the violation is noncompliance, the provisions of the IRB Noncompliance Policy will apply.

May/June 2014

Data Security Plans Involving the Use, Storage or Transmission of
Electronic Research Data Constituting Sensitive Data

 

This Policy provides standards for IRB review and approval of data security plans involving the storage of electronic research data constituting Sensitive Data in human subjects research conducted at Columbia University, including Columbia University Medical Center (“CUMC”), or by Columbia University researchers. The intent of this Policy is to ensure that the protection of the privacy of research subjects and the confidentiality of identifiable research data is in accord with the requirements of HHS, NIH and FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA).

March/April 2014

GUIDANCE ON RESEARCH INVOLVING GENETIC TESTING

This guidance applies to all human subjects research that involves Genetic Testing, as defined below. It provides background information on New York’s Civil Rights Law § 79-l, which governs the confidentiality of Genetic Testing records, and discusses the implications of this law for institutional review boards (IRBs) that review human subjects research involving Genetic Testing, particularly with respect to the criteria for IRB approval of such research and the requirements for obtaining informed consent and laboratory certification.

January/February 2014

Consent Form Template for Minimal Risk Research

The minimal risk consent form template was developed as a tool to facilitate the development of consent forms that include elements required by federal regulation. It is a guide but the language that is provided can and should be customized to apply to your study. You are not required to use this template or consent format, however readability and health literacy factors have been considered and incorporated into this template.

Minimal Risk Consent form template

 

Minimal Risk Consent form template for studies involving audio/video recording

December 2013

Clinical Trials Registration in ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more About Clinical Studies, including relevant History, Policies, and Laws.

November 2013

Disclosure of Social Security Numbers Outside of Columbia for Research Purposes

Disclosure of Social Security Numbers (SSNs) to entities outside of Columbia for research purposes requires authorization from institutional officials and high level security precautions, in addition to approval by the IRB.

October 2013

Enrollment of Non-English Speaking Subjects

 

This Policy sets forth the IRB requirements for recruitment and informed consent of human subjects who are not fluent in English (“Non-English Speaking Subjects”) in all research studies conducted by Columbia faculty, employees, and students.  This Policy is intended to ensure that Non-English Speaking Subjects are (a) included in research studies with accommodations for their lack of fluency in English and (b) adequately provided with the information necessary to exercise informed consent.

July 2013

Responsibilities of Sponsor-Investigators

Sponsor-Investigator (S-I) means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational product is administered, dispensed, or used.  When an Investigational New Drug (IND) exemption or Investigational Device Exemption (IDE) is held by the individual who is conducting the clinical investigation, the individual is considered to be an S-I.

When a Principal Investigator (PI) is acting as a Sponsor-Investigator, additional consideration must be given as to how compliance with FDA requirements will be maintained. The Columbia FDA Compliance Program for FDA-regulated Human Subjects Research outlines the institutional oversight of S-I research.

The IRB and CTO work together, under the provisions of the FDA Compliance Program for FDA- regulated research, to ensure that regulatory requirements are met.

June 2013

GUIDELINES FOR SHORT-TERM VISITORS IN RESEARCH-RELATED ACTIVITIES

Columbia University benefits from the presence of many visitors who come to the University for limited periods of time to participate in its research and, at the Columbia University Medical Center, its clinical programs. In many cases, such visitors are appointed as officers of research or instruction or designated as visiting scholars or visiting scientists, as set forth in the Columba University Faculty Handbook.  In a few exceptions, short-term visitors have no appointment, formal affiliation, or designation with the University (“Non-Affiliated Visitors”). Non-Affiliated Visitors may include high school students, visiting undergraduates, post-baccalaureates, and other observers (who observe, but do not practice, research or clinical techniques or processes) or trainees (who receive training in research or clinical techniques or processes, including practice with appropriate supervision).

While the presence of visitors promotes the mission of the University, we have an obligation to ensure that their activities are conducted in a safe, professional and responsible manner.  All visitors are subject to University policies and procedures, as well as applicable federal, state and local laws that may apply to their activities.  These Guidelines are designed to facilitate adherence to these policies and procedures. 
May 2013

WITHDRAWAL OF SUBJECTS FROM FDA-REGULATED STUDIES

This guidance provides insights on how to best handle subjects who voluntarily drop-out from a clinical trial or are withdrawn from the study by the clinical investigator. It also helps to clarify FDA’s longstanding policy that data that has already been collected from subjects must be retained in the study data for the given clinical trial even if the subject voluntarily drops-out of the study. Based on the FDA’s October 2008 “Guidance for Sponsors, Clinical Investigators, and IRBs – Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials”, it provides additional guidance to the Columbia University “Informed Consent Policy”.
April 2013

Additional Requirements for Research Involving Pegnant Women

Pregnant women, fetuses, and neonates are a vulnerable population and, as such, require additional protections when they are research subjects. It is recognized, however, that pregnant women, fetuses, and neonates should not be denied the benefits of participating in research. Distinction must be made between studies for which the reproductive status of the pregnant woman or the unique characteristics of fetuses and neonates are criteria for inclusion in the research, and studies for which the pregnancy status of the woman is incidental.

During their review of research that involves pregnant women, the Columbia IRBs consider the requirements of the DHHS and FDA regulations for the protection of vulnerable human subjects and must make specific determinations related to risk, benefit, and informed consent

Awareness by researchers of the regulations and affiliated required determinations will facilitate inclusion, in the submission to the IRB, of the information that must be considered before these determinations can be made.

March 2013

Additional Requirements for Protocols Funded by Specific Federal Agencies or Subject to Specific Federal Policies

During the review of research that is supported or conducted by specific federal agencies, and/or is subject to the requirements of those agencies, or is subject to specific federal policies, the Columbia IRBs consider the respective requirements as they relate to the protection of human subjects and must make specific determinations, e.g., consent, reporting, monitoring. These requirements are in addition to the requirements for approval of research that the IRB considers for all research involving human subjects.

Awareness by researchers of these regulations, policies, and affiliated required determinations will facilitate inclusion, in the submission to the IRB, of the information that must be considered before these determinations can be made.

 

                                                             

    

  

  

  

  

  

 


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