The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
The first two questions the IRB faces is whether the activity involves research, and second, whether it involves human subjects. Research is defined by the regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. Human subjects are defined by the regulations as “living individual(s) about whom an investigator (whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.
In addition, some research that involves human subjects may be exempt from the regulations requiring IRB. Examples include educational testing and survey procedures where no identifying information will be recorded that can link subjects to the data, and disclosure of the data could not reasonably place the subjects at risk of civil or criminal liability or be damaging to the subjects’ financial standing, employability, or reputation; and research that involves the use of existing data, documents, or specimens, where no identifying information will be recorded that can link subjects to the data.
To all investigators
Thank you for your interest in conducting research at St. Barnabas Hospital. In order to expedite your application please carefully follow the instructions below. Prior to review of your study, the following completed documentation is required:
- Cover Letter
- Briefly describe the study. The Principal Investigator (PI), must be a licensed or certified health professional. He/she must sign the letter.
- Please include all investigators’ current email addresses
- IRB application
- Please delete application instructions that are written in italics when responding to each section.
- All investigators need to sign the application.
- Consent form(s)
- Use the St. Barnabas Hospital letterhead form.
- If you believe that your study does not require written informed consent, you must justify the reason(s) for your belief by letter to the IRB.
- CITI training certificates are required to meet HIPAA training requirements for each research/investigator on the study. (CITIProgram.org, register if you haven’t already, then login and go to SBH Health System).
- Application fee: $300.00
- A check is to be made payable to the St. Barnabas Hospital IRB.
- St. Barnabas Hospital Investigator(s) may request waiver of said fee.
- Additional document(s)
- Copies of questionnaires used in the study, if applicable.
- Copies of data collection tools, if applicable.
- Email the completed application to:
- Submit a hard copy of the entire completed application package
- Mail or hand deliver to Dr. David Rubin, fourth floor, Mills Building
Failure to submit or complete all of the above documentation will delay the reviewing process of the study and the entire application will be returned to you. Please also note that your completed application must be received 10 business days before the monthly IRB meeting, which is held the second Tuesday of each month, in order be considered to be reviewed that month. If you have any questions or need any help after carefully review the instruction above, please don’t hesitate to e-mail firstname.lastname@example.org at any time.
Application of the Health Insurance Portability and Accountability Act to Research Activities
In compliance with HIPAA regulations, all those who conduct research involving human subjects need to complete training with regard to privacy in the context of research. This training is required of any doctor, nurse or medical personnel who conduct or help to conduct a research project that has been submitted to the St. Barnabas IRB. The general HIPAA training session completed by all staff does not fulfill this requirement.
This research specific training is self-directed. It involves the viewing of a slide presentation and review of hospital policy as it relates to HIPAA and research. After the completion of the assigned tasks, a compliance letter needs to signed and submitted to the IRB. You should submit the signed and dated letter at the time the research project is submitted to the IRB.
Furthermore, at the time you submit your IRB application, you will attach a cover letter to the application. As part of that cover letter, you must describe how your study will comply with HIPAA (e.g. use of written authorization, de-identification, request for waiver etc.). The details are described within the slide presentation and specific hospital policies.
Each time a new project is submitted, a new copy of the compliance assurance letter is required. Please do not submit random compliance assurance forms without including either your study title or study number provided by the IRB.
Attached below you will find all the necessary documents or links:
SBH HIPAA-5 “De-Identifying and Re-Identifying Patient’s Health Information”
SBH HIPAA-9 “Use of Patient Information in the Conduct of Research Activities”
St. Barnabas Hospital Privacy Notice