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MP Guidelines -- Human Subjects
What Is "Human Subjects Research?"
If you are interviewing people or administering surveys
to them (by phone, mail, email, or in person), you may
be doing research on human subjects as part of your MP.
Such research must conform to federal and university standards
for protection of human subjects of non-medical research.
If you ask only questions such as "How many birds did you
see?" then that's not research on human subjects. If you
ask questions about your respondent's attitudes, opinions,
preferences, behavior, characteristics (e.g., "How often
do you visit the Duke Forest?" or "Would you pay a fee in
order to preserve this wetland?" or "What conservation organizations
do you belong to?") then you are doing research on
human subjects.
Certification
In this case, both you and your MP advisor must
be "certified" for research on human subjects and
you must obtain approval of your research protocol from
the Institutional Review Board before you begin any
data collection from human subjects. You and your advisor
can become certified by (1) attending the skills module
session on human subjects research given each year by staff
of the Human Protections program of the Duke Office of Research
Support , or (2) completing the online certification process.
To complete the online certification process, go
to the online module "Protecting
Research Subjects" register yourself, complete
the module, choose "IRB certification" (rather
than continuing education credit), and then notify
the IRB staff that you have completed the module.
If your advisor does this type of research, s/he should already be certified. If s/he is not certified, then either (1) s/he needs to complete the certification process, or (2) Charlotte Clark, who is certified, has agreed to fill this role as far as signing off on requests for approval of research protocols. She can do this only if you prepare your research protocol and complete the forms for requesting approval well in advance of when you intend to begin collecting data.
Approval of Research Protocol
The forms for requesting approval of research protocols
can be found online.
Most, but not all, NS research on human subjects qualifies
for exemption, but you must file the appropriate request
for screening for exemption and receive approval of that
request for exemption before you begin collecting
data.
Violations and Sanctions
The Human Protections program serves the worthwhile purpose
of protecting human subjects from invasion of privacy, embarrassment,
retaliation, discrimination or other harms that might result
if their responses to research questions were misused. If
you fail to follow the procedures required by federal and
Duke policies on human subjects when collecting data for
your MP, you will not be permitted to use those data in
your MP.
Data Collected Outside of Duke
Complications can arise for NS students who use data from
human subjects collected away from Duke. If you are the
one collecting the data, and if you are going to use those
data for your MP, then all the procedures above apply (advisor
and student certification, approval of research protocol
from Duke IRB). If you are working away from Duke (e.g,
in an internship), be sure that your internship supervisor
realizes that these Duke procedures must be followed and
that data collection cannot begin until approval has been
received.
If your internship is with a research organization (e.g.,
another university, a research think tank, such as Resource
for the Future), then ask if that organization has an IRB.
If so, your supervisor from that organization should take
the lead in obtaining approval from that IRB, rather than
from Duke's IRB, but the Duke IRB needs to see the letter
from your local IRB approving your protocol. Don't proceed
without it!
If the organization you are working for is not a research
organization (e.g., local government, consulting firm, nonprofit
organization), they probably do not have an IRB. Currently,
organizations that do not receive federal funding are not
subject to federal regulations for protecting research subjects.
However, as a Duke student you are subject to the regulations.
Thus if the organization has collected data for research
or for non-research purposes (such as improving their services
to clients) and you wish to use these data for your MP,
then you must follow Duke IRB procedures and get approval
of your research protocol before you begin working
with the data.
These situations can get quite complicated, so always check
to see if you have the necessary approvals before you begin
collecting data from human subjects, or before you begin
working with data from human subjects collected by someone
else.
For more information, contact Charlotte Clark
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