Educational Training Requirements
Under the University’s Federalwide Assurance with the HHS, all Investigators (i.e., principal investigators, co-investigators, faculty sponsors as well as other research personnel who have involvement with human subjects need to demonstrate a basic knowledge of human research ethics, regulations, laws and local policies prior to initiating research with human subjects. At NYU, educational training has been assured for all research personnel who are involved with human research subjects. All NYU Investigators are required to take the Collaborative Institutional Training Initiative (CITI) course for Social and Behavioral Research Scientists. Detailed information and links to CITI are available here.
Please note that the CITI course is the minimum requirement to conduct research with human subjects.
Full Board Review Process – New Applications
The Committee meets once a month to consider applications that require full board review. Prior to each monthly meeting, every new full board application is assigned to a primary and a second reviewer who present the results of their review to the convened board. The new application is then considered by the full Committee. Based upon its review and deliberations, the Committee makes a recommendation.
Notification in writing of the Committee's decision is sent via electronic mail to applicants approximately five business days after the meeting. This notification will:
- Detail the reasons that approval was not granted and what must be done (e.g., requests for revisions or additional information) to allow the protocol to receive final approval; or
- Grant approval to proceed with the proposed work. Notification of approval will include stamped consent, assent and parental permission forms (if applicable), copies of which must be used for all subjects. Unstamped forms may not be used; or
- Request the submission of a new Application because the Committee considers the Application not to be ready for review. Please see the UCAIHS Policy on Review and Return of Applications below.
Expedited Review Process – New Applications
Applications that are eligible for expedited review (minimal risk research as defined at 45 CFR 46.110(b)(1)) are considered for approval outside of the monthly board meetings. The list of expedited categories is available on the federal government’s Office of Human Research Protections website. Each application is assigned to one or more experienced UCAIHS members (designated by the chairperson) who conduct the review. The expedited reviewers determine whether the research does qualify for expedited review and either approve or request minor changes to the application. Expedited review findings are then reported to the UCAIHS at its convened meetings. If an expedited reviewer determines that a study cannot be reviewed via an expedited review procedure or finds that it cannot be approved, the study is referred to the full Committee to be reviewed and discussed at the next available meeting.
Notification in writing of the decision will be sent via electronic mail to applicants within five business days of the expedited reviewer’s determination. This notification will:
- Request minor revisions to the application and/or supporting documentation; or
- Detail the reasons that approval cannot be granted (did not qualify for expedited review and has been referred to the full board or application was incomplete and cannot be reviewed); or
- Grant approval to proceed with the proposed work. Notification of approval will include stamped consent, assent and parental permission forms (if applicable), copies of which must be used for all subjects. Unstamped forms may not be used.
Administrative Review Process-New Applications
Applications that fit the criteria for an administrative review must fall into one or more narrow categories of human subjects research (minimal risk as defined at 45 CFR 46.101(b) categories) that the federal government has determined are exempt from federal oversight. Although these categories of human research are exempted, each institution that conducts research with human subjects must provide assurance to the federal government that there is a review process in place in which someone other than the researcher makes the exempt determination. At NYU, the UCAIHS is the reviewing body that makes these determinations.
To determine whether your research may fall within one or more of the exempt categories of research, investigators should review the Office of Human Research Protections’ Human Subject Regulations Decision Charts.
If an application is deemed exempt from further review, the investigator receives notification within one to two weeks of submitting a complete application. No further reporting is necessary unless the investigator modifies the research. The UCAIHS maintains records of its administrative reviews in its active files for a period of three years. If the investigator intends to conduct research under the exempt protocol for more than a three year period, the UCAIHS should be notified.
Amendments to Approved Research Activities
Any changes to a previously approved research project, such as amendments to the inclusion/exclusion criteria, study population, study procedures, addition or deletion of investigators, or revisions to the consent process must be approved by the UCAIHS before the changes may be implemented. Depending on the level of risk to the study subjects, amendments may be reviewed through either an expedited or a full board review process.
If an amendment application is determined to fall within the parameters of the expedited review procedures as defined by the federal regulations at 45 CFR 46.110(b)(2), the investigator should receive notification within one to two weeks of submitting a complete application.
If an amendment application appears to increase the risks to study subjects to more than minimal risk as defined by the federal government, the application would be placed on the agenda for full committee review and recommendation at the next available meeting.
Applications other than those deemed exempt under the administrative review process require annual review as specified under the Federal regulations at 45 CFR 46.109(e). Depending on the level of risk to the study subjects, annual review may be conducted through either an expedited or a full board review process.
Review of an application by the UCAIHS takes a significant time commitment by volunteer full-time faculty, members from the community and the UCAIHS staff. It is therefore important that all submitted applications are clear, readable, complete, and consistent with federal regulations and University policies, and with the submission instructions posted on this website.
Because of the time demands involved in such reviews, applications that are unclear, unreadable, incomplete, inconsistent, or that are submitted on outdated forms (please ensure that current application forms are used) will be returned to investigators and a complete re-submission requested. The decision to return an application may be made prior to the meeting by the reviewer(s), by the UCAIHS Committee Chair, or by a UCAIHS administrator. Whenever feasible such notice will provide general feedback to assist investigators with the resubmission. If you have any questions concerning the review process or contents of the application, please contact the UCAIHS Office at 212-998-4808 or via e-mail at email@example.com.