What needs IRB Review?
How do I know if my project needs IRB review?
What is the definition of Research?
What is the definition of a Human Subject for research purposes?
How long with the NIH training for Human Research Protection take?
If I know my project is exempt; may I begin interacting or intervening with human subjects?
Where do I find sample forms?
Does Oral History Research need IRB review?
Where do I submit IRB Materials?
What is the IRB?
The Boston College (BC) 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 BC or by affiliates of BC. 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 BC policies for the protection of human research subjects.
What needs IRB Review?
All data collected by an interaction or intervention with human subjects must be approved by the BC IRB or be exempted by the administration BEFORE the project begins. This applies to ALL data collection involving human subjects conducted at BC or by BC agents, including data collection in the humanities and behavioral and social sciences, whether the research is externally funded or not.
How do I know if my project needs IRB review?
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.
What is the definition of Research?
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 Boston College has) is also governed by this definition.
What is the definition of a Human Subject for research purposes?
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).
How long with the NIH training for Human Research Protection take?
The NIH training module takes approximately 2 hours to complete. When you sign on you will create a password (please write down the password) that will allow you to revisit the site and complete the training in small increments and may be used as a general refresher for the concepts covered in the training session.
If I know my project is exempt; may I begin interacting or intervening with human subjects?
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 at (link to forms). As soon as you receive a written notification of Exemption from IRB review, you may begin your research.
Where do I find sample forms?
Click here for sample forms.
Does Oral History Research need IRB review?
It depends.
If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the BC 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.
Who Can I speak with to help me?
Call the Office for Human Research Participant Protection at (617) 552-4778
Where do I Submit IRB Materials?
All applications must be submitted via irb@bc.edu . Investigators are encouraged to sign the application digitally using Adobe. If you are unable to digitally sign, manually sign the last page of the application and fax, scan (and send with electronic materials) or send the page by campus mail to the Office for Research Protections (ORP) located on the Chestnut Hill Campus, Waul House, Third Floor.
Mailing Address:
Office for Research Protections
Boston College
Waul House, Third Floor
270 Hammond St.
Chestnut Hill, MA 02467