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FAQs

What is the IRB?      
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 will the NIH training for Human Research Protection take?
If I know my project is exempt; may I begin interacting or intervening with human subjects?
May I begin to recruit subjects before I receive approval for my protocol?
Where do I find sample forms?
Does Oral History Research need IRB review?

Who can assist me with my IRB questions?
Where do I Submit IRB Materials?
How long will it take to get approval for my project?
I am in a rush. Can I get approved right away?
How long is IRB approval valid?
How do I go about making changes to a protocol?  
How long is my human subjects training certificate valid for?
What is a site permission letter?

How does informed consent work for research conducted online?
What are the deadlines for submissions?
Why does the training requirement apply to faculty advisors?

 


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 will the NIH training for Human Research Protection take?
The NIH training module takes approximately ninety minutes 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. As soon as you receive a written notification of Exemption from IRB review, you may begin your research.

May I begin to recruit subjects before I receive approval for my protocol?

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.

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 assist me with my IRB questions?
Call the Office for Research Protection at (617) 552-4778 or email us at irb@bc.edu . We are available during regular business hours. We are also happy to meet with you. Please call ahead to arrange a time to come in to Waul House. We are located on Hammond Street between Murray and Hovey House.

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

How long will it take to get approval for my project?
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 ORP. Approval for protocols that are expedited typically take twenty days while exempt approvals take less than ten and full board protocol are typically between thirty and sixty days. These are just estimates. Kindly note that approval of a project may take longer in the summmer.

I am in a rush. Can I get approved right away?
It has been our experience that all PI’s are in a rush to get their protocols approved. ORP must treat everyone equally. Therefore, protocols are processed in the order that they are received. ORP rarely accepts requests for fast approvals.  We encourage PI’s to carefully follow the instructions on submitting a protocol in order to avoid delays and submit their protocols as early as possible.

How long is IRB approval valid?
IRB approval for expedited and full board protocols are valid for one year. The expiration date can be found on the approval letter and on every page of the approved protocol materials. 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. ORP will issue a continuing review reminder letter to PI's so the protocol can be renewed and this can be avoided.

How do I go about making changes to a protocol?  
PI’s should complete an amendment form to make changes to an approved protocol. All changes, no matter how minor, must be approved by the IRB before being implemented.  Investigators must submit amendment forms to add research staff to their protocol. All research staff must comply with the IRB Training Policy and have a valid training certificate. The certificate should accompany the amendment form at the time of submission and all of the materials should be combined into a single PDF and emailed to ORP at irb@bc.edu.

How long is my human subjects training certificate valid for?
If the training certificate complies with the IRB training policy, the training certificate is valid for three years from the date of the training. If the training certificate is due to expire, PI’s 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 ORP or with expired training certificates should be removed from a study until they have updated their training.

What is a site permission letter?
If you are conducting research at a site e.g. a school, you must obtain letters of support from the Principal or Administrator. The letters must be on letterhead and must be signed. These letters should be submitted with the application. There is a sample site permission letter on this website.

How does informed consent work for research conducted online?
The IRB may waive the requirement to obtain a signed consent form in certain circumstances. If an investigator is administering an online survey, the consent form should appear on the first page of the survey and, to the extent possible, ask participants to click on a button indicating consent before they can begin the survey. Investigators should complete a consent waiver/alteration form and attach it to their IRB application at the time of submission.  

What are the deadlines for submissions?
Exempt and expedited protocols are reviewed as they are submitted. The only protocols that have any deadlines are full board protocols. Protocols that are more than minimal risk require the review of the full board at a convened IRB meeting.  Full board protocols should be submitted ten (business) days in advance of an IRB Meeting. IRB Meetings are held every 3rd Wednesday of the month.

Why does the training requirement apply to faculty advisors?
Faculty Advisors serve as mentors to student researchers and share the responsibility for the ethical conduct of the research with the student. It is therefore important that faculty advisors are fully trained in the protections of human subjects in research.