FAQ'S
Please Note: The Tulane University HRPO website is an excellent source of information. The
Investigator Guidance tab includes General Guidance Documents, Checklists, Tips and
Templates, and Specific Guidance Documents. Under General Guidance, there is a very
helpful presentation entitled, “10 Steps to IRB Approval”; this presentation has proven to
provide assistance as new PIs apply for IRB approval of their human subjects research.
Please view our website: http://tulane.edu/asvpr/irb/
You may contact us via email at irbmain@tulane.edu or via phone at 504-988-2665.
1. What is an IRB?
An institutional review board (IRB) is a committee that has been formally designated to
approve, monitor, and review biomedical and behavioral research involving humans. They
conduct a risk-benefit analysis in an attempt to determine whether or not research should be
completed. The number one priority of IRBs is to protect human subjects from physical or
psychological harm. In the United States, the Food and Drug Administration (FDA) and
Department of Health and Human Services (specifically Office for Human Research ProtectionsOHRP) regulations have empowered IRBs to approve, require modifications in planned research
prior to approval, or disapprove research.
2. What qualifies as human subjects' research (and thus requires IRB approval)?
A. Definition of a Human Subject under the Common Rule, 45 CFR 46
Human Subject means 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.
Intervention 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. 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).
Citation from the Code of Federal Regulations—Section 102(f) of 45 CFR 46
Note: Private information must be individually identifiable in order for obtaining the
information to constitute research involving human subjects (i.e. the identity of the subject is or
may readily be ascertained by the investigator, whether an investigator at Tulane or at another
institution, or associated with the information).
B. Determination of Human Subject Involvement
The key questions to answer in determining whether a research activity involves a “human
subject” are:
1. Will data ABOUT a living individual be obtained through an intervention or interaction
with that individual?
2. Will identifiable private information be obtained about a living individual?
If the answer to either question is yes, the research involves “human subjects” and the
proposed research proposal must be submitted to the HRPO for the appropriate review
and approval prior to initiating the research.
C. Additional Aids to Determination of Whether “Human Subjects” are Involved in Research
Examples of Research Activities that do not involve “human subjects”

The study of individually identifiable private information about dead persons, and no
intervention or interaction with living individuals will occur;

the study of public information about living persons, and no intervention or interaction
with living individuals will occur; and

the study of publicly available information files, such as publicly available census files, in
which persons are not identifiable (including, but not limited to, the presence in the file
of names; social security numbers; codes which the owners of the file or a researcher
could reasonably use to identify a living individual; combinations of information from
which a person’s identity could easily be determined, such as zip code and birth date)
and no intervention or interaction with living individuals will occur
Note: The preceding bulleted activities would meet the Federal regulatory definition of “human
subject” if anyone, at any point in time, beginning with the commencement of the proposed
research, holds information necessary to link a file record to the identity of any living person and
the information in that record would be considered private information.
D. Definition of Human Subject Decision Chart
A decision chart entitled, “Chart 1: Is an Activity Research Involving Human Subjects Covered by
45 CFR 46?” from the Office of Research Protections (OHRP) of the U.S. Department of Health
and Human Services (DHHS) may be helpful in determining whether a research proposal
involves “human subjects” as defined in HHS Regulations (45 CFR 46 Common Rule). You can
find this and other decision charts on the OHRP website:
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
3. I need to obtain IRB approval, where do I start?
Complete human subjects research training (CITI Training). Before beginning research at Tulane
University, all research personnel must complete the CITI Training Program. A Certificate of
completion is to be submitted for all research personnel when applying for IRB approval.
CITI Training can be completed online at:
www.citiprogram.org
If the research is Biomedical, all study team members should complete the Biomedical (group 1)
Research for Investigators and Key Personnel course.
If the research is Social Behavioral, all study team members should complete the Social and
Behavioral (group 2) Research for Investigators and Key Personnel course.
CITI Training certificates expire four years from the completion date and the completion date is
listed on the certificate.
Please see the CITI Training Guidance Document on our website for more detailed information
regarding completing CITI Training and how to submit the Certificate(s) for review.
4. What do I need to submit?
The Tulane University HRPO has created a thorough Initial Submission Checklist for
Expedited/Full Board submissions and a Checklist for Exempt submissions. These can be found
on our Website by clicking the Investigator Guidance tab, under the heading ‘Checklists’
http://tulane.edu/asvpr/irb/
5. How do I know if I am applying for Expedited/Full Board review or for Exempt Review?
The OHRP has issued categories of research. The Tulane University HRPO has Guidance
Documents to assist you in determining if your research may qualify as Exempt or for Expedited
review. The research may be referred to the Full Board for a determination if the research
involves a greater than minimal risk to subjects or involves a vulnerable population.
Please see the Guidance Documents on our website under Investigator Guidance entitled:
Types of Review
Criteria for Exempt Determination
Criteria for Expedited Determination
http://tulane.edu/asvpr/irb/
6. How do I submit an Application for IRB review?
All Tulane submissions are made through IRBNet, an electronic submission and study
management system. Use of the system requires you to create an account with IRBNet. You
will find all our Forms, Checklists, Templates, etc. on the IRBNet system.
www.irbnet.org
The Tulane University HRPO has constructed an IRBNet Users Guide, which walks users through
the submission system step-by-step. This can be found on the HRPO website. In addition,
there is a short video of how to put together an initial submission. This helpful video can also
be found on the HRPO website.
http://tulane.edu/asvpr/irb/
7. When is my submission going to be processed?
The length of time that it takes to review an IRB submission depends significantly on the quality
of the application, when it is received by the IRB, and the type of review that it requires.
Submissions that are incomplete will not be processed until all documents have been submitted
to the IRB. Please see the Review Timeline Table below. For Full Board submissions, there are
submission Deadlines; please see our website and click the Deadlines and Meetings link.
Keep in mind that incomplete submissions will delay the amount of time it takes to process and
review your application.
8. How will I know that I have approval to conduct my research?
Once your Application is reviewed by a board members, a Decision Letter will be published
within IRBNet. You will receive an email notification that a letter has been published.
To locate decision letters:
INSTRUCTIONS FOR LOCATING YOUR ACTION/DECISION LETTER
Step 1:
Login to IRBNet; www.irbnet.org. This will take you to the MY PROJECTS page.
Step 2:
Click on the Title of the project for which you would like to retrieve the action letter.
Step 3:
Click on PROJECT HISTORY and then the PACKAGE TYPE of the specific submission
(package #).
Step 4:
Click on PROJECT OVERVIEW and then REVIEW DETAILS. The action letter is located in
the BOARD DOCUMENTS section at the bottom of the page.
9. Once IRB Approval has been obtained, do I have to maintain it?
Yes, any Amendment to the research (Protocol, Consent Documents, Questionnaires, etc.) are
to be reviewed and approved by the IRB prior to implementing. Continuing Reviews are
required of all Expedited and Full Board studies, as these studies will expire. Any Protocol
Deviations and Unanticipated Problems are to be submitted to the IRB for review. In addition,
once all research has been completed, including all analysis of collected study data, a Study
Closure is to be submitted.
Please see our website under Investigator Guidance, the Specific Guidance Documents contain
information on these types of submissions.
http://tulane.edu/asvpr/irb/
10. Can an investigator begin research on human subjects without prior IRB approval?
No, all research involving human subjects must obtain final IRB approval prior to beginning any
and all research activities (including subject recruitment). Human subjects research conducted
without IRB Approval is considered investigator non-compliance.
Other Topics:
What if I were to forget to submit my application for continuing review?
As a courtesy to investigators, the IRB sends investigators study renewal reminder(s) prior to
the expiration of the study. It is the responsibility of the Principal Investigator to ensure that
the continuing review submission is submitted via IRBNet in sufficient time to be reviewed prior
to the study's expiration. You may submit continuing review applications 60 days prior to the
expiration date, and you should ensure that a continuing review has been submitted at least 30
days before the expiration date to allow enough time for the IRB review. If an investigator has
failed to provide continuing review information to the IRB, or the IRB has not reviewed and
approved a research study by the continuing review date, IRB approval expires automatically
and all research activity must cease, unless the IRB finds that it is in the best interests of
individual subjects to continue participating in the research interventions or interactions.
The continuation of research after expiration of IRB approval is a violation of the regulations 45
CFR 46.109(e), and 21 CFR 56.103(a). However, if the investigator is actively pursuing renewal
with the IRB and the IRB believes that an over-riding safety concern or ethical issue is involved,
the IRB may permit the study to continue for a period of 30 days following the expiration date.
If a renewal request is received within 30 days of expiration, the request will be processed as
continuing review. After 30 days following expiration, the study is officially closed and cannot
be reopened. The IRB will administratively close expired studies and send the principal
investigator a closure notification.
Do HIPAA regulations apply to data sets containing protected health information (PHI)?
Yes. Protected health information is any information that relates to the past, present or future
physical or mental health or condition of an individual. HIPAA regulations require researchers to
have valid authorization for all uses and disclosures of research-related PHI. A valid
authorization must include specific elements:
- A description of the PHl being used.
- A statement of the purpose of the use of PHI.
- A list of those who can use the PHI.
- A list of those who can receive the PHI, including the possibility of re-disclosure.
- A statement that once PHI is disclosed by the recipient it may no longer be protected by the
Privacy Rule.
- Information about the expiration of the authorization.
- Information about the right to revoke the authorization.
- Individual identifiable health information consists of:
Names
- Social security numbers
- Geographic information including street address, city, county, precinct, zip code, and their
equivalent geocodes.
- Voice and fax telephone numbers
- Web universal resources locators ( URL ) and Internet Protocol (IP) address numbers
Email addresses
- Health plan beneficiary numbers, medical record numbers, or other health pla11 account
numbers
- Vehicle identifiers and serial numbers, including license plate numbers
- Device identifiers and serial numbers
- Biometrics identifiers, including finger and voice prints
- Full face photographic images and any comparable images
- All elements of dates (excluding year) including birth date; admission date, discharge date,
date of death
Information is considered de-identified if all of the above identifiers have been removed, and
there is no reasonable basis for belief that the remaining information could be used to identify
a particular person