All MPH students are required to prepare a Research Protocol outlining their planned fieldwork project. However, effective Spring 2016, only those that are considered human subjects research will be submitted to the IRB. The five categories of Fieldwork research projects that do not require IRB approval are outlined below.
1. Meta-analysis of published data
2. Analysis of de-identified, publically available data sets (e.g., US Census Bureau data, Youth Risk Behavior Survey, NHANES, BRFSS). The use of data from public data sets is not considered human subject research as long as the following criteria are met:
3. Grant proposals that do not include data analysis
4. Practicum experiences that do not involve data collection or analysis
5. Research on organizations (i.e., information about operations, budget, etc. from spokespersons or data sources; does not include identifiable private information about individual members, employees, or staff)
Students must consult with their Faculty Advisor, Site Preceptor and the Graduate Practicum Director on their campus to make the determination that their Fieldwork does not require IRB approval. After review of the student’s research protocol, the Faculty Advisor, the Site Preceptor and the Graduate Practicum Director must must sign the student’s Fieldwork Contract attesting to their decision that the project does not require IRB approval.
Students who were in Fieldwork I in Fall 2015, are planning a Fieldwork project that falls into one of the five categories of fieldwork research projects described above and who have already submitted their IRB but have not received a decision have two options:
Students who were in FW I in Fall 2015 who have received IRB approval should continue with their project as approved by the IRB. They should not withdraw their IRB.
The mission of the HSPP is to support the University's research enterprise by ensuring the protection of individuals who participate in research; ensuring compliance with all pertinent federal and state laws and regulations; fostering the ethical conduct of human subjects research; and providing education and other services to the University's researchers regarding regulatory requirements and best practices.
HSPP assures that the University fulfills its institutional responsibilities for the conduct of research involving human participants, under the University's three Federalwide Assurances filed with DHHS-Office of Human Research Protections (OHRP); the regulatory requirements of the Food and Drug Administration (FDA); state and local laws; institutional policy; and all applicable sponsor requirements.
HSPP consists of three University IRB Campus Systems, in Newark, New Brunswick and Stratford, under one Federalwide Assurance (FWAs); a contractual relationship with Western IRB (WIRB) for review of industry-sponsored protocols conducted by Rutgers faculty at Rutgers performance sites; a program of education for faculty and other researchers; and an audit/review program for oversight of studies in progress.
All Rutgers faculty, students, and other individuals involved in human subjects research are required to complete the Collaborative IRB Training Initiative (CITI) Basic Course and to complete the CITI Refresher Course every three years thereafter. This requirement also extends to all IRB members and Human Subjects Protection program staff.