WPUNJ Institutional Review Board for Human Subject Research
Training and Certification of Researchers and Educators in the Use of Human Subjects in Research
To insure that investigators and instructors involved in human subject research have an adequate background in the ethical principals and requirements governing research involving human subjects as well as the requirements and processes related to the conduct of human subject research at WPUNJ, investigators and instructors must provide certification of human subject research or research ethics training to the IRB. Certification must be received prior to the acceptance of a research protocol for review. Protocols from students of an instructor who has not been certified will not be accepted. (WPUNJ IRB Policy, Part V (1))
The WPUNJ IRB Training and Certification Program is primarily the web-based CITI Program that provides information and a competency test on the current Federal IRB regulations as well as WPUNJ's IRB Policy, procedures and forms. The IRB will offer occaisional workshops to assist in the completion of the CITI Program and "brown bag seminars" for the discussion of IRB-related issues.
Certification of Training is required for all William Paterson University faculty, staff and outside investigators who are serving as the principal investigator, co-principal investigator or senior-level support of research involving human subject, as well as
Certification of Training will be determined on a project-by project basis for other research project support staff who have direct contact with subjects, with original data collection tools/resources, or with information that identifies subjects.
Proof of previous Certification of Training will be accepted for individuals who fulfilled this requirement at another institution. A WPUNJ-specific certification will be required to fully meet this requirement.
Certification of Training is required for faculty teaching courses that include instruction related to human subject research and/or requiring students to undertake human subject research will be required beginning with the Fall 2006 Semester. Certification will be required prior to the receipt of student research protocols.
Proof of previous Certification of Training will be accepted for individuals who fulfilled this requirement at another institution. A WPUNJ-specific certification will be required to fully meet this requirement.
Certification of Training is required for all members of the IRB, the Responsible Institutional Official, the IRB Chair, and the IRB Administrator.
Certification of Training is strongly suggested for Deans and Department Chairs of academic units that include faculty who are involved in human subject research and/or have courses and/or students that include or undertake human subject research, as well as Vice Presidents, Associate and Assistant Vice Presidents, and Directors of administrative units that include staff who are involved in human subject research. Certification should be provided to the IRB prior to the approval of research involving human subjects.
Graduate and undergraduate students who are undertaking human subject research AND when the course faculty has provided Certification of Training to the IRB. A sponsor of undergraduate or graduate students may require their students to obtain Certification of Training.
CITI Program: This educational program consists of a Basic Course for Social & Behavioral investigators and Basic Course for Biomedical investigators as well as courses and related resources for other investigators. The WPUNJ component directs researchers, investigators and administrators to specific modules in both Basic Courses and to a module on WPUNJ's IRB policy and process. Following completion of the program, certification is provided to both the person completing the module as well as WPUNJ's IRB Administrator.
Click here to access the CITI Program to register and begin the program. You may exit and return as many times as needed to complete the program. A score of 80% is required to obtain certificiation. Please be sure to select the appropriate certification program.
If you would like to review the modules included in the CITI Program, please click here: modules list.
If you would like to preview the test which follows the module on WPUNJ's concerns and processes, click here: WPUNJ IRB Module test
There are many web-based resources for educators instructing students in the use of human subjects in research. These can be found on the Internet through Google or another meta-search tool, as well as through the DHHS Office of Human Research Protection (www.hhs.gov/ohrp), offices at particular Federal agencies, and WPUNJ Office of Sponsored Programs. Resources should be selected based on particular course needs and the expectations of your particular discipline. One general item would be: