IRB Frequently Asked Questions
Accordion Content
-
Effective January 7, 2002, New Jersey law requires that school districts obtain written parental consent prior to administering to students surveys or other specific study instruments which would reveal information concerning certain topics listed in the law (NJSA 18A:36-34). If written informed consentis not obtained, then students may not participate in surveys or assessments which fall within the scope of the law.
Although this law refers explicitly to surveys and other instruments which the school district administers, the law does not reflect research which is not administered by the school district. However, cautious districts may interpret this law to apply to all research conducted in their schools. Investigators who have approved or proposed protocols that include the administration of surveys, assessments, analyses or evaluations in a New Jersey school district should be aware of this legislation and recognize that written parental permission may be required in districts. In addition, it is possible that some districts will react conservatively and decide to restrict all survey research rather than attempt to obtain parental permission for each individual study.
Protocols that involve surveys in schools should be submitted to the IRB as usual; however, in spite of IRB approval, the final decision of whether or not to permit the survey to be conducted rests with the individual school district. Investigators are advised to secure permission from the district as early as possible so that consent procedures may be modified if necessary.
-
Rutgers University Brain Imaging Center (RUBIC) [Newark, NJ] enables Rutgers-affiliated researchers, other institutions in the region, and individuals/organizations in the business world to conduct a wide variety of studies at their facilities. RUBIC is run by Rutgers faculty and staff who bring extensive knowledge and experience to their research. The RUBIC Common Practices applies to all research with human subjects that will be performed at RUBIC. Protocols should be submitted to the Rutgers IRB via eIRB+. Researchers should go to the Rutgers IRB Submission website to submit their application. These common practices have been approved by the Rutgers IRB on 06/23/2011.
-
In accordance with the Rutgers University Federalwide Assurance #FWA00003913 “ensuring prompt reporting to the IRB, appropriate institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any: (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance with the Federal Regulations or IRB requirements, and (iii) suspension or termination of IRB approval” The Federal Office of Human Research Protections (OHRP) may also be informed of non-compliance.
-
When “Conditions Pending for Approval” is indicated on the memo issued by the IRB, you must address all conditions listed in the memo and resubmit the application to the IRB. You may not begin your research until you have received final IRB “approval” or “approval with stipulations”. The conditions typically involve unmet requirements which need to be addressed and approved by the IRB before you may begin your research.
This may also affect the release of funds related to a funded grant. Please see Research and Sponsored Program’s Compliance: Human Subjects (IRB) for more information.
-
When “Approval with Stipulations” is indicated on the memo issued by the IRB, you must address all stipulations listed in the memo via a modification application submission in eIRB+. In most cases, you may begin your research or part of your research, but the stipulations will outline exactly what can and what cannot be started. Once your stipulations have been met, the IRB will update the approval to “Approved”.
-
None. You may not begin the research until you have received an “Approval” or “Approval with Stipulations” memo from the Rutgers IRB. You must not begin any research related activities before you receive approval.
An official approval notification will be sent to the PI via e-mail from the Rutgers eIRB+.