rev. 09/02/03
BOSTON COLLEGE
Institutional Review Board (IRB)
INSTRUCTIONS FOR INVESTIGATORS
This form has been revised in order to ensure that all research conducted at Boston College is in
compliance with all federal requirements and consistent with our ethical standard of conduct.
If you are planning to conduct a study involving human participants, please note the following:

For externally funded research, please wait until you have been notified that your project will be
funded before submitting a protocol application to the IRB. Submit documentation of funding
status with the protocol application.

Please refer to the BC Consent Guide for the required format for Consent and Assent Forms.

Each investigator listed on the IRB protocol must complete either the web-based human
participant protection tutorial or a program approved in advance by the BC IRB. The webbased tutorial may be found at http://cme.nci.nih.gov. Please submit copies of the certificates of
completion with the IRB application.

Principal Investigators who will be working with health information must complete the
“Statement on HIPAA PHI Use.” Submit this form with the IRB application, as applicable.

For student research projects, please note that the student’s advisor is required to sign the
application by which he or she is certifying that he or she will oversee the project in its entirety.

Submit the correct number of copies of the Application for Review of Research Proposal
Involving Human Participants and related documents (see checklist, last page). Be sure to keep
a complete copy of all materials for your records.

Please provide complete responses to all questions. This will help speed the review process.
Incomplete protocols will be returned to the principal investigator, resulting in delays in
protocol approval.

Questions about submissions should be directed to Rachel Krebs (Administrative Director,
Office for Human Research Participant Protection, 552-4778). Advance consultation can
facilitate the process of review. Protocols should be submitted to Rachel Krebs, Office for
Human Research Participant Protection, 21 Campanella Way, Rm. 551.
See the checklist matrix at the end of the form for complete documentation requirements.
PI’s Last Name:
rev. 09/02/03
Boston College Institutional Review Board
Office for Human Research Participant Protection
Carney Hall 116
Phone: 617-552-4778
FAX: 617-552-0948
APPLICATION FOR REVIEW OF
RESEARCH PROPOSAL INVOLVING HUMAN PARTICIPANTS
(Cells will expand as needed)
DATE
New [ ]
Resubmission [ ]
Principal Investigator
(Last, First, Credentials)
Investigator Rank (e.g.,
Professor, Graduate Student)
Faculty/Staff Advisor (if
appropriate)
Department or School
Interoffice Address (or home
address)
_________________________
Telephone Number
E-mail address
Title of Project (If there is a
sponsor, title must match the
sponsored title)
( ) University
( ) External (identify source and grant number)
*Wait until you have been notified that your project will be funded before submitting
Source of Funding
protocol application to the IRB. Submit documentation of funding status with protocol
application.
*If federally funded, submit copy of the grant application to the IRB
( ) None
Your signature below indicates that you accept responsibility and have followed the ethical guidelines set forth by the
Belmont Report, Declaration of Helsinki, the Nuremberg Code, or the Ethical Principles of your discipline in developing
the research described.
Signature of Principal Investigator
Date
Your signature below affirms that a scientific review of this research has been conducted, and represents your approval
of the research.
Signature of Dept Chair or Dean
Date
Your signature below affirms that you have reviewed this application and that you will oversee the project in its entirety,
including any final or termination report.
Signature of Faculty Advisor
Date
1
PI’s Last Name:
rev. 09/02/03
Note: If you will be working with data that has been collected anonymously or data that is publicly available, please first
review the Exemption Categories to see if your research qualifies for exempt status. If you think your research qualifies for
exempt status, please complete the Application for Exempt Status instead of the BC IRB protocol application.
IRB Review Category:
Does your research qualify for Expedited Categories or full Committee review?
*Research must present no more than minimal risk to human participants in order to qualify for
expedited review. Minimal risk means that “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 tests.” (45 CFR 46.102)
[ ] Full Committee Review
[ ] Expedited Review
If you are requesting expedited review, designate the category that qualifies this proposal for expedited review
Expedited Categories and provide a justification for the expedited review category. Include any information that will assist
the reviewer in making a determination. The text box will expand.
Category # _______
1.
2.
A. STUDY OBJECTIVES: What are you hoping to learn as a result of this research?
B.
RATIONALE/JUSTIFICATION FOR STUDY: What is the scientific or scholarly reason for this study?
C.
PARTICIPANT POPULATION:
 What is the source of participants, materials, or data?
 How many people will participate in the study?
 What is the age range of the sample? If minors are excluded, provide justification.
 What is the gender representation of the sample? If either gender is excluded, provide justification.
 Will all racial/ethnic groups be included? Explain any exclusion.
D.
PROCEDURES:
 Describe in detail the procedures that will be followed with participants.
 Specify which procedures are for research and which procedures are part of standard treatment, care, or
interaction with the participants, as applicable.
 Where will the data be collected? (If data are to be collected at a public site, have appropriate permissions
been granted?)
2
PI’s Last Name:
 If video or audio recordings will be presented to participants, provide details about the nature of these
recordings and submit a copy of the media with your application.
rev. 09/02/03
 Does this research involve instrumentation (e.g., questionnaires, interviews, observational scales,
etc)? [ ] yes [ ] no
o If yes, submit copies of the instruments to be used.
 Could this research uncover any incriminating information (for example does it include drug testing,
questions about sensitive topics, etc.)? [ ] yes [ ] no
If yes, a Certificate of Confidentiality may be required. For more information on Certificates of Confidentiality,
visit the website at http://grants.nih.gov.grants.policy/coc/index.htm.
Does this research involve the recording of responses with audiotapes, videotapes, photographs, or
other electronic media?
[ ] yes [ ] no
If yes, specify how the confidentiality of the information will be maintained, explain how the media will be stored,
provide details about who will have access, and estimate how long the media will be kept before being destroyed. Be
sure to include this information in your consent form.
 Will you be working with health information?
[ ] yes [ ] no
o If yes, complete the “Statement on HIPAA PHI Use” form
o Send any agreements regarding the use of PHI (protected health information) to the Office for
Human Research Participant Protection
E.
F.
ANALYSIS PLANS:
Describe your plans for analysis of the data. Is the number of participants adequate? Provide a power
analysis when applicable.
INCLUSION/EXCLUSION CRITERIA
G. RECRUITMENT TECHNIQUES (indicate with an “X” all techniques which apply):
[]
Letters to professionals (Submit with application)
[]
Letters to prospective participants (Submit with application)
[]
Advertisements
(Submit copy of the advertisement)
[]
Telephone Script (Submit script)
[]
Brochures, flyers, and/or pamphlets (Submit with application)
[]
[]
*Note: If you will be distributing and/or posting brochures, flyers, and/or pamphlets at an off-campus location,
please submit an approval letter from the organization where the materials will be distributed/posted to the BC
IRB
e-mail messages or web postings (Submit with application)
Other
(Explain below)
How will the recruitment process take place?
Who will be responsible for recruiting participants? Are these people also responsible for providing participants
with any treatment or care?
How will recruiters be compensated for their recruiting efforts?
3
rev. 09/02/03
PI’s Last Name:
H. VULNERABLE POPULATIONS (Indicate which special classes will participate in the research)
[ ] Pregnant Women/ Fetuses (see 45 CFR 46 Subpart B
[ ] Healthy Volunteers
and contact the Administrative Director, BC Office of Human
Research Participant Protection, x24778)
[ ] Minors (0 through 17 years)
 Complete the “Studies Including Minors” form
[ ] Persons with Cognitive Impairment
[ ] Persons in drug rehabilitation or living in homeless
shelter
[ ] Prisoners (see 45 CFR 46.305 and contact the
[ ] Persons with Severe Illness
[ ] Third Parties
Administrative Director, BC Office for Human Research
Participant Protection, x24778)
[ ] Persons not fluent in English
Explain what additional protections will be in place for participants from a vulnerable population.
I.
INFORMED CONSENT (Provide information about all forms)
 TYPE (Indicate the type of consent with an “X”):
[ ] Standard Written Consent
Note: Please refer to the BC Consent Guide for the required consent format. Consent forms must also be
placed on BC letterhead.
[ ] Waiver or alteration of consent
 Complete and submit the “Waiver of Informed Consent” form
[ ] Waiver of written consent (i.e. verbal consent, implied consent)
 Complete and submit the “Waiver of Written Consent” form
[ ] Non-English speaking (submit consent form in English and consent form in the language of participant.
Explain procedures used for the translation of the consent form).
[ ] Third Party
 PROCESS
 When (in what time frame) and where will consent take place?

Who will be responsible for obtaining initial and ongoing consent? When this
responsibility is delegated to someone other than the PI, explain how the individual(s) will
be prepared to obtain informed consent for the research activity.
J. POTENTIAL RISKS
 What are the potential risks to participants? Be sure to address emotional, social, and financial risks.
 Are there any risks to family, school or social group? If so, please specify.
 Does this research qualify as minimal risk or greater than minimal risk?
[ ] minimal risk
[ ] greater than minimal risk
Minimal risk means that 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 tests.
Provide justification for risk category:
K.
MINIMIZING POTENTIAL RISKS
 How will risks be minimized?
4
PI’s Last Name:
rev. 09/02/03
L.
DESCRIBE POTENTIAL BENEFITS OF PARTICIPATION IN RESEARCH (note: compensation is not a benefit)
 To participants:

To society:

Discuss how the above stated benefits to participants and/or society outweigh the risks inherent in the
research.
M.
ALTERNATIVES (Address only if experimental therapy or intervention are involved)


What alternatives are there for the prospective participants other than choosing not to participate in the
study?
If alternatives will not be included, why will alternatives (above) not be used?
[ ] No alternatives exist
[ ] Current available alternatives are not proven to be effective
[ ] Current available treatments are known to be effective however research treatment has the potential
for being more effective
[ ] Other (explain)
N. CONFIDENTIALITY
• Specify how confidentiality will be maintained:
•
Where will the data be stored and who will have access to the data?
•
Will identifiers be stored with or separate from the data? Also, when will identifiers be destroyed?
•
How long will raw data be kept and what are the plans for the destruction of raw data?
•
What are the plans for dealing with identification of illicit or abusive behavior?
Note: It is important to state in the consent form(s) how confidentiality will be maintained. Please incorporate the
answers to the above-listed questions into the consent form(s).
O. Financial Components of the Research
Will there be any additional costs to participants? [ ] yes
 Will participants be remunerated? [ ] No [ ] Yes
[ ] no
Amount:
• When will participants be remunerated?
 How will remuneration be affected if participation terminates before the end of the study?
P. FOR MULTI-SITE RESEARCH OR RESEARCH NOT CONDUCTED AT BOSTON COLLEGE:
5
PI’s Last Name:
rev. 09/02/03

List all Research Site(s)
[ ] Site has an IRB - It is the responsibility of the BC PI to ensure that IRB approval has been obtained and that the BC IRB
has a copy of the approval.
[ ] Site does not have an IRB.
Is BC acting as the coordinating center for other study sites?
[ ] yes [ ] no
If yes, it is the responsibility of the BC PI to ensure that all collaborating sites have obtained IRB approval. Be sure to submit a
copy of all external IRB approvals to the IRB staff.
Federally funded research: Please note that for federally funded research, all research sites must have an FWA on file with the
Department of Health and Human Services (DHHS), Office for Human Research Protection (OHRP). If a site does not have an FWA
and will be involved with federally funded research, please call the Administrative Director, BC Office for Human Research Participant
Protection (x24778) for guidance on how the other site(s) may obtain an FWA.
Research with Schools: Please submit copies of approval letters from the principal of each participating school or an IRB approval
letter from the school board, if applicable. These documents must be submitted to the BC IRB before IRB approval can be released.
Research with Hospitals: Please note that an IRB application must be submitted to the participating hospital’s IRB in addition to
submitting an IRB application to the BC IRB. Once an IRB application has been submitted to the participating hospital’s IRB, please
contact the Administrative Director, BC Office for Human Research Participant Protection (x24778) as an additional agreement may
need to be signed between BC and the participating hospital. Please wait until the hospital’s IRB has granted IRB approval before
submitting the IRB protocol application to the BC IRB along with a copy of the hospital’s IRB approval letter.
Q. RESEARCH PERSONNEL
Please list the names of all individuals who will interact with the research participants and/or review participantidentifying information. Please note that evidence (i.e., certificate of completion) of completion of a human
research participant protection program is needed for each individual.
Name and credentials (Expand table
E-mail Address
Research Role
University/Department
as needed.)
R. CONFLICT OF INTEREST
Do you or will you, your spouse or dependent children, or any investigator
participating in this study have, or anticipate having, any income from, or
financial interest in, the sponsor of this research protocol or supporting
organization (Financial interest includes but is not limited to consulting, speaking
or other fees; honoraria; gifts; or licensing revenues, and equity interests/stock
options of an annual or fair market value of $10,000)?
Do you or will you, your spouse or dependent, or any investigator participating in
this study have, or anticipate having, any income from,
or financial interest in, a company that owns or licenses the technology being
studied (technology includes but is not limited to pharmaceuticals, procedures or
devices)? Income and financial interest is defined above.
If yes, please specify the extent of involvement.
For those projects funded by NIH, NSF, or commercial entities, do you
have a current, up-to-date Conflict of Interest Disclosure on file with the
Office for Sponsored Programs that describes this financial relationship?
[ ] No
[ ] Yes
[ ] No
[ ] Yes
[ ] No
[ ] Yes
S. To your knowledge has this research study been reviewed by any IRB? [ ] yes [ ] no
6
rev. 09/02/03
PI’s Last Name:
If yes, provide information about which IRB reviewed the study, when it was reviewed, and what the outcome was.
T. Are there other relevant issues or considerations that may affect or be present in your research project of
which the IRB should be made aware? If so, please specify them:
Materials needed for submitting an IRB Protocol Application:
1. Submit a packet that includes the original BC IRB application with all signatures, spell checked, and typed
along with the following materials, as applicable:
 All consent/assent forms to be used, in 12 point font minimum
 Instrumentation (e.g., Interviews, questionnaires, telephone scripts, etc.)
 Recruitment material (e.g., letters to professionals, letter to prospective participants, brochures, flyers,
pamphlets, etc.)
 All appendix forms that are relevant to your study
2. Expedited Review: Submit the original protocol application and relevant materials plus 2 copies
or
Full Committee Review: Submit the original protocol application and relevant materials plus 20 copies
3. Submit copies of human research participant training certificates for the PI and all research personnel, as
listed in Section Q of this protocol application.
4. Federally funded research: submit a copy of the federal grant application.
5. Research with health information: complete and submit the Statement on HIPAA PHI Use form [add hyperlink]
6. Research in hospitals: submit copies of the IRB approval letter and IRB approved consent form(s) from the
participating hospital(s).
7. Research in schools: submit copies of the approval letter(s) from the principals of participating school(s)
or IRB approval from the school board, as applicable.
Any applications that do not meet the above standards will be sent back to the PI without being reviewed.
7