Information
Regarding Requirement
for
Institutional Review Board Approval
All UND research involving
human participants and conducted by university personnel or students must be
reviewed following UND IRB procedures, and must be approved prior to the initiation
of research activity and contact with potential human participants. There are
no exceptions to this policy. If you are
going to complete research with human subjects and collect the data at another
institution (hospital, clinic, etc.), you may also be required to obtain
approval from the institution's review board.
Obtaining Required IRB Approval:
Step 1. Overview of Requirements: The Office of Research and Program Development website will provide an overview for preparing and submitting an IRB proposal and a link to the Researcher's Handbook. A careful review of this information will simplify the approval process.
Step 2. Complete
Required Human Subject Education:
a. Why is
training necessary? As a result of recent suspensions of research
organizations because of noncompliance with regulations governing human
subjects research, the Department of Health and Human Services (DHHS) has
emphasized the need for those individuals involved in this kind of research to
understand their obligations under the regulations. Recent regulations have
specified that an educational program must be provided for investigators by
institutions operating under the federal regulations governing human subjects
research.
b. Who has
to take the training? Principal Investigators and those individuals
in contact with subjects and/or data and identifiers (key personnel) will need
to complete the training.
c. When do
I need to complete this training? All investigators and key personnel
submitting proposals or Research Project Review and Progress Reports will be
required to complete the training before approval of their proposal is granted
by the IRB. The Principal Investigator should ensure that all key personnel have
completed the training prior to submitting their Research Project Review and
Progress Report or proposal. Approval will be suspended until all key personnel
have completed training.
d. How do I
complete this training? The training is done by
completing the IRB On-Line Educational Modules. Individuals may register on the
website to complete the
required modules. The required modules are listed. For most research
projects students will want to complete the medical modules,
however some students may have to complete the social-behavioral module
depending on the research topic. Researchers
will be asked to complete additional modules if they are using vulnerable
populations as subjects such as prisoners, international, workers as research,
conflicts of interest, pregnant women or genetic research. It will take approximately 24 hours to receive your
password and log in. Each Module will take 10 to 30 minutes. The total required
time is estimated to be two to three hours. The course does not have to be
completed in one sitting and can be completed in any order. The passing score
required is 80% (required modules only). If you fail the training or want to
improve your score you may retake any or all of the modules. This process may
take a couple of days.
If you have forgotten your password or ID please call (701) 777-4279.
Step 3. Complete HIPPA
Training: The School of Medicine and Health Sciences requires
that each enrolled student must complete HIPPA
Training. An online program is available
for your use to access this training on the UNDSOM web page or at the
HIPAA training site. You may need to submit a "Student HIPPA
Form" or verification of the completion of HIPPA training with your IRB
Proposal. (Check with the IRB where you
submit your proposal.)
Step
4..
Determine the approvals needed
for your project:
a. Research completed by UND
students: If you are collecting data at UND or another
location/facility that does not have an IRB, you will submit your proposal to
the UND IRB. The forms you will use will
be on the UND IRB web page (http://www.und.edu/dept/orpd/regucomm/irb/Default.htm). Refer to the Researcher's Handbook (UND IRB
web page) to determine the type of approval needed and which forms to use.
b. Research completed by UND students at
another site with an Institutional Review Board: If
you are collecting subject data at a site (hospital, clinic, etc.) that has an
IRB, you may be required to obtain approval from the facility IRB. In this situation, you have two options to
consider.
(1) IRB Authorization Agreement. You may complete an "IRB
Authorization Agreement" which will allow UND IRB to rely on another IRB
outside of a UND for the review of a project.
The form is documentation of who has responsibility for the project
review and approval and must be signed by both authorized agents of both IRBs (see
sample form attached). You would then
submit this signed and a copy of your approved IRB proposal to the UND IRB
office.
(2) Submission to More than One IRB: If you are not able to obtain a
signed IRB Authorization Agreement, you will submit your proposal to both the
institution's and UND's IRB. Generally,
you will submit the proposal to the institution where you will be collecting
the data initially. However, you should
check with the IRB coordinator at both facilities for directions regarding the
procedure to follow.
Step 5. Prepare the IRB Proposal: Follow the Researcher's Handbook when developing the
text for your IRB proposal. The
IRB
Forms can be downloaded from the ORPD website. Use the IRB Checklist form to verify that you have completed
the proposal appropriately. If you are
planning on using the Internet to obtain data, you will also need to review
section entitled Internet Research and comply with the criteria that applies to your
research project.
a. Consent Form
b. Letter of
Willingness to Cooperate from cooperating institution(s) or individual(s)
c. A copy of
instrument(s) such as surveys, etc. and or interview questions (if applicable)
d. Release
of Student Educational Forms for each student researcher
e. HIPPA Student Form (if applicable)