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| Training | Documents Needed | Submitting Materials | Resources |
The faculty, staff, and
students of SUNY Oswego are obligated to comply with
Federal Department of Health and Human Services regulations for the
protection of human participants in research. Any member of the campus
community participating in a research project --including but not
limited to laboratory experiments, field studies, and interviews -- is
entitled to be free from possible injury and/or psychological harm and
to maintain his/her personal privacy. The committee was formed to
ensure that these guidelines are followed, therefore protecting human
research participants used by researchers on our campus, which can include subjects off-campus and those not our students, such as K-12 students.
Membership for 2009-2010:
Barry Friedman, co-chair, Marketing and Management
David Bozak, co-chair, College of Liberal Arts and Sciences
Rebecca Burch, Psychology
Barbara Garii, Curriculum & Instruction
Michael Huynh, Campus Ministry
Mark Hardy, Technology Education
Joshua McKeown, International Education and Programs
Ernest Nickels, Public Justice
Matthew Spindler, Vocational Teacher Preparation
Glenn Wachter, Education Administration
Patrick Witmer, student
GUIDE FOR USING HUMANS AS RESEARCH PARTICIPANTS AT SUNY OSWEGO
by Stephen A. Wurst, Ph.D., Psychology Department, SUNY Oswego
In order to conduct research using humans as participants in
research at SUNY Oswego, you must first obtain approval
from the Campus Human Subjects Committee (HSC). A member of this
committee reviews the proposed research to determine if the research
follows the ethical standards set by the Code of Federal Regulations
(45 CFR 46). The committee member will review the proposal only in
regard to the ethical nature of the proposal; we do not review the
proposal critically for content unless it impacts on the ethical issue
(e.g., we may suggest a correlation strategy if we believe the
experimental manipulation is questionable ethically). You must obtain
approval before you recruit or run any participants.
How is this review accomplished? First, each researcher must have completed mandatory training in protection of human subjects in research. Then the researcher needs to submit four major documents to Barry Friedman.
Mandatory Training
To comply with a federal requirement to provide training and
education in the protection of human participants in research, SUNY
Oswego requires mandatory and continuing education for all
investigators and research personnel involved with human participants. To be certified, research personnel
must complete NIH (National Institutes of Health) Training, Sections 1 - 6 and print your certificate. This free training course should take approximately two hours to complete. NIH Certification is good for 2 years.
Register for the course or sign in
Documents needed
- Proof of Completion of Mandatory Training You should include a copy of the NIH Certificate indicating that you have successfully completed this training course within the past two years.
- Transmittal form You can download and
print a copy of the transmittal form
(31K .pdf) from this website. On this sheet, fill in the researchers' names and
the title of the research, and check "yes" or "no" for the questions
about your participant population and intended procedures. The
information for the protocol is supplied at the bottom of the
transmittal form. Also, for student research, obtain the signature of
the faculty sponsor.
Reminder to Students: Sign the transmittal form and have your faculty sponsor sign
the form. Also, make sure that you print the title of the research, and
all authors (and faculty sponsor when appropriate), in the space
provided at the top of the transmittal form.
- Research Protocol The protocol must contain the following and can be submitted
in paragraph form, or addressed point-by-point:
- A brief description of the research. Please present an overview of what your research entails (a statement of your design would be appropriate)
- A description of the potential benefits to the participants and to "science." if you are using undergraduate students in your
department, you can mention how participating in the research will help
them understand research better. Also mention how your results will
improve our knowledge of your research area.
- A description of how the participants will be used. What we are looking for here is
a statement of what the participant will be doing. Write what
manipulations the subject will be exposed to, and what the subject will be asked to do. If you are using a questionnaire or
personality test, please attach a copy. Writing that you
are using a questionnaire about "suicide" or "sexual behavior" won't
help us review research on these sensitive topics if we don't read what
is included in the questionnaire.
- A description of who the participants are. Briefly describe your participants. For many projects,
introductory psychology students, or students from other classes, are
used as participants. If you are using any other populations, specify
who they are (e.g., age, grade levels K-12, , elderly, etc.) and how they will be
recruited to participate. (Also see note below about other populations).
- A description of any
potential risks to the participant, and how
these risks will be minimized. Most projects may seem innocuous, but
have potential risks. For example, if you wanted to manipulate
"self-esteem", "frustration level", or "mood", you need to address how
the participant will be "un-frustrated", etc. You should mention any conceivable physical
risk. For example, if you instruct your
participants to do a task at a computer screen for two hours, the
possibility exists that eye strain and a headache might result.
However, this risk certainly would not occur if the participant did the
task for five minutes. Try to use your judgment as to what is
"conceivable" and what is "highly improbable".
- The informed consent form The last major document is a copy of the informed consent form that you
give each participant immediately before the research begins. The
"consent" form is signed by the participant to allow you to run the
participant in your research; "informed" means you must provide enough
information about the research so that the participant can make this
decision. The consent form must contain the following information
(Grunder, 1986):
- the names of the experimenters
- the nature, purpose, and expected duration of the research
- a statement that the research has been approved by the HSC
- how the data will be used
- a brief synopsis of the method
- any possible hazards or risks
- any benefits that may occur (for the participant or "science")
- a statement of confidentiality
- a statement that the participant may withdraw from the study at any time without penalty
- an offer to answer questions about the research, including phone numbers
- consent statement and blank lines for the participant's and the experimenter's signatures
These points should be written in a readable form. Remember, many of
your participants have not been in research studies before, and may be
apprehensive. Try to express this information concisely, but without
the jargon of your field. These points should all be included, but you
don't need to state each one in order. We have provided an example of an Informed Consent document.
You may have noticed many of these points are the same as in your
protocol. The risks and benefits (#5 and #6), the method (#4), and the
nature of the study (#2), can all be reworked from your protocol.
Additional clarification may be needed for some other points. Note
in (#2), the expected duration is required. It is important to let the
potential participant know how long he/she can expect to run. Someone
may consent to a 30-minute experiment, but not a 2-hour experiment. For
(#3), briefly state if group means will be used to report the results,
etc. For (#9), include your phone number in case the participant has
any later questions about the experiment. Also include the HSC
chairperson's name and phone number, but explicitly state that this number is for questions concerning the participant's rights as a research participant.
The nature and purpose of the research can also be a tricky issue if
you are using a cover story or deception. Try to state your purpose
broadly, without telling the participant exactly what your true purpose
is. If the deception is not risky, the proposal may receive approval. A
debriefing/dehoaxing statement will be especially important in these
situations. Refer to the document concerning debriefing participants. (Debriefing statements will be required for other research as well).
You must give the consent form to participants as they come to the
room to participate in your research. After verbally explaining the
consent form to the participants, and giving the participant ample time
to read it, the participant then decides to consent or not. You should
have the participant sign TWO copies: one is for the participant to
keep; the other is for your files. Label on the PARTICIPANT COPY, and
the other the EXPERIMENTER COPY. The experimenter should also sign both
forms. (Ideally, a third-party witness should sign, but this is not
feasible in most cases and is not necessary). In an effort to save
paper, you may be able to put both copies of the consent form on a
single 8.5" X 14: sheet, and simply cut the paper in half so both the
participant and the experimenter has a complete copy of the consent
form.
Also, if your department has a policy of allowing extra credit to
students who participate as participants in research, check with your
department to see what procedures are used to record extra credit. For
example, in the Psychology Department, experimenters fill out credit
slips and give these slips to the participants. It is then the
participants' responsibility to turn the credit slip to her/his
professor to receive the extra credit.
- SPECIAL CASES: Some populations are designated as special populations
of participants and require additional precautions. One of these
populations is children/minors. For example, when using children/minors
as participants, you must obtain the signed informed consent from the
child's parent or guardian, and obtain the child's verbal assent. Other
"special" populations are: prisoners; pregnant women; cognitively
impaired persons; elderly persons; and terminally ill or comatose
patients. Talk with your faculty supervisor or the HSC chair to find
out what additional measures must be taken with these populations.
Finally, you should also provide subjects with a Debriefing document.
Submitting your materials
Submit a PHOTOCOPY of the above
documents to the chair of the Human Subjects Committee. These documents
are kept on file and WILL NOT BE RETURNED. Four actions are possible at
this point:
- the proposed research will receive an "expedited review" and be accepted without revision
- The proposed research will receive an "expedited review" and
tentatively be accepted if the suggested minor revisions are made; or
- the proposed research is not approved, but more major revisions
will be suggested that would make the proposal acceptable when
re-submitted to the HSC; or
- the proposed research is sensitive enough that it requires review by the entire HSC
If accepted without revision, you will receive an "Expedited Review
Form" (ERF) and an "Acceptance of Review Form" (ARF). You keep the ERF
for your records; complete the ARF and return to the HSC chair.
If the proposal is tentatively approved with revisions, make the
appropriate revisions in your documents and resubmit. You will then
receive the ERF and ARF.
A full committee review is time-consuming and probably would not be
suitable for a semester course project. (If it is a project you are
interested in doing, but deals with sensitive issues or "special"
populations, a student could be encouraged to do the project as an
independent study that could span two or more semesters).
Any Questions?
We hope that this guide answers most of your questions about the
HSC's procedures. If you have any other questions, please contact a
member of the Human Subject Committee.
Resources
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