IRB Frequently Asked Questions
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 new law refers explicitly to surveys and other instruments which the school district administers, but not to research which is not administered by the school district, cautious districts may interpret this law to apply to all research conducted in its 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 new legislation, and recognize that written parental permission may be required in districts that did not previously request it. 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] facility enables researchers with Rutgers, other institutions in the region and the business world to conduct a wide variety of studies. 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 and researchers should go to the Rutgers IRB Submission website for general submission information. 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.
If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the Rutgers IRB before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they wish any or all of the oral history archived.
An Additional Condition is an unmet requirement which may prevent all or some of your research from being conducted until it is fulfilled. Conditions will be noted on your Notice of Approval in the Additional Condition Section. Some Additional Conditions are ongoing and will require fulfillment throughout a research project. When an Additional Condition is fulfilled, you will receive a confirmation from the IRB, usually through e-mail. Once the PI receives this confirmation, he/she may commence research activities which were affected by the condition.
This may also effect the release of funds related to a funded grant. Please see Grant Congruency for more information.
To submit a document related to an additional condition, please submit an amendment form and include any additional required document(s).
- 12-345: The 12 indicates the fiscal year in which your study began.
- 12-345: The 345 is the number of your study.
- E12-345: The E indicates your study is Exempt.
- 12-345: If your study does not have a “E” in front, it is a FB or Expedited Study. Studies without a “M” or “R” have not been approved and will be added when approved.
- 12-345R: The R indicates your study is Greater Than Minimal Risk and requires Full-board review.
- 12-345M: The M indicates your study is Minimal Risk and is eligible for Expedited Review.
- 12-345M15: A number after your protocol number indicates when your study last complete a De Novo review. This will only be found on FB/Expedited Studies.
- 12-345Rp: The p indicates your study contains prisoners.
- 12-345Mc: The c indicates your study contains children under 18 years old (Letter is added For FB/Expedited Studies Only).
- 12-345Mx: The x indicates your study is in Data Analysis only (Category 8c). No interaction with study subjects is allowed.
None. This includes data analysis (with anonymous data as well). If you are collaborating with another school and you received a Notice of Approval from them and you are waiting for a Notice of Approval from Rutgers, you must not begin any research related activities before you receive a Rutgers Notice of Approval.
An official notice of approval will be sent to the PI as a PDF in an e-mail from the Rutgers IRB.
Files should be transported only by study personnel or by authorized parties in a secure manner. Contact the IRB for more information based on your situation.
When conducting research using Rutgers-New Brunswick students as your subjects, the IRB highly suggests that you coordinate data collection plans and recruitment efforts with the Student Affairs Research and Assessment office. This Division often collects direct and indirect measures of learning, benchmarks with peers, and uses assessment results to improve programs and services. This collaboration can enhance your scholarship by providing guidance and expertise on student development and reduce survey fatigue among students. Dr. Dayna Weintraub, Director, can be reached at (848) 932-8576 or by email at email@example.com.