Office of Research and Sponsored Program Services
Electronic Review of Human Subjects Research Protocols (e-IRB)
All research conducted by faculty and students from the School of Nursing involving human participants or their health or medical information must obtain the approval of Rutgers Biomedical Health Sciences (RBHS) e-IRB to comply with University and Federal policies regarding human research participation. The RBHS IRB website provides helpful information including sample forms, a standard protocol format, calendar meeting dates, information on translations, training, etc. To ensure faculty and students at the School of Nursing receive timely approval of protocols, we provide the following guidance:
Use this downloadable checklist to avoid common mistakes in filling out your online application at eIRB
1. Non-Human Subjects:
Project data is not generated directly by individual participants; nor is it drawn from medical or health records of any individual. Examples include:
- Systematic Reviews
- Policy Research
- Studies of Organizational Structure that do not involve interviews or surveys of behavior, attitudes and opinions of individuals.
The link below is an example of an approved SYSTEMATIC REVIEW at the School of Nursing:
Systematic Review: The association between prenatal exposure to environmental tobacco smoke and childhood obesity: a systematic review protocol
Exempt protocols are one of the more common protocols at the School of Nursing. Qualitative research proposals may be exempt if they meet certain criteria. Exempt protocols are characterized by very low risk and either anonymous responses of participants or publicly observed behavior of participants. Secondary data analysis may be exempt if there are no HIPPA defined Public Health Identifiers (PHI) collected and the population recruited is not considered vulnerable by the IRB. Vulnerable populations include pregnant women, prisoners, those with cognitive limitations, minorities, and students among others.
The link below is an example of an approved EXEMPT PROTOCOL at the School of Nursing:
Exempt Protocol: Evaluating the Effect of Expanded Child Welfare Nursing Services on the Health Care Outcomes of Children in Foster Care
This is also a very common review type at the School of Nursing. Qualitative proposals that are not exempt; to which most survey research fall under this category. Expedited protocols must involve minimal risk to participants as well as low participant burden. They must include standard protections of confidentiality and data security. Any correspondence between PHI, including medical record numbers, and the data set must be stripped before data analysis, be limited to as few individuals as possible and destroyed as soon as possible.
The link below is an example of an EXPEDITED PROTOCOL at the School of Nursing:
Expedited IRB Approval - Social Networks and Health Outcomes (SNaHO) in SSA Immigrants
Written Protocol | Application
4. Full Board Review:
A limited number of studies at the School of Nursing typically require a full board review, however, the IRB may decide that some expedited protocols require full board review if the population or nature of the data collection is warrant. Usually this happens when they believe there is more than minimal risk, the population is vulnerable, the data being collected is sensitive, or the confidentiality of participants will require special attention in order to be adequately protected.
The link below is an example of an approved FULL BOARD protocol at the School of Nursing:
Full Review - Empowering Daughters and Mothers
Written Protocol | Application
Qualitative Research Support Tool
Qualitative Research is the most frequent type of project developed at the School of Nursing by both DNP students and faculty. “IRB Boards and Qualitative Research” presentation is produced by the Principal Investigators Association. It is a 60-minute webinar by seasoned PI, Jo Ann Schneider, PhD, on how to prepare effective IRB applications for qualitative research projects. For those who wish to read instead or to print out the slides in order to take notes, the accompanying pdf includes all of the slides, plus sample consent forms and other materials from the projects discussed during the presentation. An index for the pdf is provided for your convenience. These sample documents show the level of detail and how to clearly demonstrate adherence to definitions and criteria that all IRBs must follow, although for any given project, the local IRB may identify specific issues.
Consent Form Samples:
- Pp. 1-9 Power Point Slides used during the Webinar
- 20 Bonus Handouts Begin
- 21 IRB Regulations for Exemption and Expedited Protocols
- 26 Sample Approved Documents for an Expedited Protocol
- 37 Sample Approved Documents for an Exempt Protocol
- 68 Ethical Concerns and Informed Consent for Students
- 72 GWU IRB sample forms, including elements of a research protocol
E-COI is an electronic system which allows faculty to disclose actual and potential financial conflicts of interest and develop management plans if necessary, so that their research maintains objectivity and is free from bias. Faculty must disclose such conflicts at least annually. E-COI communicates directly with IRB and faculty can certify or update their disclosures at the time a new protocol is submitted.
Rutgers Office of Research and Sponsored Programs – Conflict of Interest Guidance
RAPSS is the electronic gateway for the submission, review, approval and tracking of all federal proposals and their related budgets at Rutgers University. The RBHS Central Office of Research and Sponsored Programs (RBHS ORSP) provides additional information, training, and support.
Grant Submission Process
Internal budget and compliance reviews are required for all federal, state, discretionary and foundation proposals. RAPSS handles most federal proposals (NSF is an exception). The submission process for other mechanisms are undergoing change. Please consult our office for specific direction or consult downloaded from the RBHS Central Office of Research and Sponsored Programs . A snapshot of PI/PD responsibilities and how to interface with our office appears here PROPOSAL SUBMISSION SNAPSHOT