FAQs & Glossary Terms

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A living individual 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

Includes communication or interpersonal contact between investigator and subject.

Includes both physical procedures by which data are gathered (for example venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or test.

Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

Federal regulation 45 CFR §46.102 defines research as:

“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Virtually all federally funded research with human subjects is governed by this definition. In addition, all human subjects research conducted under a Federwide Assurance (which Bentley University has) is also governed by this definition.

45 CFR §46.102 defines a human subject as:

“A living individual(s) about whom an investigator (whether professional or student) conducting research obtains: data through intervention or interaction with the individual, or identifiable private information.” Intervention includes both physical procedures by which data are gathered (for example, electrodes, venipuncture, collection of saliva) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Note: For research involving health or medical information (and/or the electronic transmission of this type of information) the definition of “private information” is not the same as the definition of “protected health information” (PHI) as defined under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The Bentley University Institutional Review Board (IRB) serves as the primary institutional body to protect the rights and welfare of individuals recruited to participate in research conducted at Bentley University or by affiliates of the University. The IRB is a federally mandated board (45 CFR part 46, the "Common Rule". 1991) that prospectively reviews and approves research that involves human beings as research subjects. Each research study that proposes interactions with human subjects must be prospectively reviewed and approved by the Institutional Review Board (IRB) or exempted from IRB review by the administration prior to the onset of data collection. All human subjects research, even if found exempt from IRB review, must follow the Bentley University policies for the protection of human research subjects.

All data collected by an interaction or intervention with human subjects generally should be reviewed and approved by the Bentley University IRB or be exempted by the administration BEFORE the project begins. This applies to ALL data collection involving human subjects conducted at Bentley or by Bentley agents, including data collection in the humanities and behavioral and social sciences, whether the research is externally funded or not.  If unsure, please contact Susan Richman, IRB Chair, by email at srichman@bentley.edu or by phone at 781.891.2660.

1. Does your project involve human subjects?
As an investigator, will you interact or intervene with a human subject or any identifiable private information on individuals? If yes, see #2 below. If no, then no IRB review is required.

2. Is your project "research" as defined under the Common Rule (45 CFR 46)?
Is your project a systematic investigation designed to contribute to "generalizable" knowledge? This means the data will be made publicly available either through presentation or publication of some sort (e.g., Web sites, tapes, archives, forum, publications, etc.)? If the answer is yes, then your study involves "human subject research". The project must be reviewed by the IRB or exempted from IRB review by the administration prior to human subject interaction or intervention.

Federal regulation 45 CFR §46.102 defines research as:

“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Virtually all federally funded research with human subjects is governed by this definition. In addition, all human subjects research conducted under a Federwide Assurance (which Bentley University has) is also governed by this definition.

NO. ONLY THE HUMAN PROTECTIONS ADMINSTRATION MAY EXEMPT A STUDY FROM IRB REVIEW IN STRICT ADHERENCE TO THE COMMON RULE 45 CFR 46. Forms to request an exemption from IRB review are available on this web site. As soon as you receive a written notification of Exemption from IRB review, you may begin your research.

The answer is no. No research or recruiting can commence until PI’s have received an approval letter for their protocol. The same holds true for amendments and continuing review applications.

It depends. If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the Bentley 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 do not wish any or all of the oral history archived.

Please submit your IRB materials via email to Susan Richman, IRB Chair, at srichman@bentley.edu.

How long a project takes to be approved depends on how complete the application is, what level of review the project qualifies for and how long it takes for a protocol to be revised and returned to IRB.

IRB approval for expedited and full board protocols are valid for one year. The expiration date can be found on the approval letter.  If a PI would like to continue with the research for an additional year, the PI must seek IRB approval by submitting a Continuing Review application sixty days prior to the expiration date of the protocol. Protocols that are not renewed will expire and be closed. A PI may not work on an expired protocol. IRB will issue a continuing review reminder letter to PI's so the protocol can be renewed and this can be avoided.

Training certificates obtained through the CITI program are valid for three years from the date of the training.  If the training certificate is due to expire, PIs should complete either the CITI refresher course or the NIH training course prior to the expiration date of their training.
 

All research staff without proper training certificates on file with the IRB, or with expired training certificates, should be removed from a study until they have updated their training.

In most cases (NIH, NSF, Dept. of Education) you will be submitting the approval information “just in time”, when you receive a fundable score, or when the agency requests the IRB approval information. All of these time frames occur prior to the release of the award to the Office of Sponsored Programs. For the most accurate information, the PI should consult the agency for guidelines for the use of human subjects.