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QUESTIONS
Who must submit a protocol?
What is the purpose of the IRB approval process?
Why does The College of Saint Rose require me to get my research
approved by the IRB?
Who evaluates protocols?
What criteria are used to evaluate protocols?
How do I know which form to use?
What are possible risks?
What is informed consent?
How can confidentiality be maintained?
How are revised protocols handled by the IRB?
What should I include in the brief summary that is to be attached to
my exempt protocol?
If I have questions about filling out the appropriate IRB form and how
to create the appropriate consent forms, debriefing scripts, etc, who do I
contact? Can I ask for help from the IRB committee?
ANSWERS
1.Q: Who must submit a protocol?
A: College policies and federal laws require that every research project
involving human participants be reviewed. Anyone affiliated with The College of
Saint Rose (as faculty, staff, or student) who is conducting research with
human participants, or anyone outside the college who is obtaining research
participants though the participants' affiliation with the college, must get
approval from the IRB before initiating the collection of data.
Federal guidelines define research as a formal investigation designed to develop
or contribute to generalizable knowledge and a human participant as an
individual about whom an investigator (whether professional or student)
conducting research obtains a) data through intervention or interaction with
the person, or b) identifiable information.
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2. Q. What is the purpose of the IRB approval process? Why does
The College of Saint Rose require me to get my research approved by the IRB?
A. The policies and laws described above are for the protection of the research
participants, the researcher(s), and the institution. The role of the IRB is to
ensure that the welfare and rights of participants have been properly
safeguarded. By having a system in place that requires researchers to assess
risk and provide safeguards for participants, the college also helps protect
researchers and the institution from liabilities posed by those risks.
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3. Q: Who evaluates protocols?
A. Protocols are evaluated by members of the Institutional Review Board (IRB).
Faculty representing each of the four schools are appointed for three year
terms to the IRB by the Vice President of Academic Affairs. Members of the IRB
review protocols to ensure that the rights and well being of human participants
are protected.
Exempt protocols are usually reviewed by a faculty member from your school.
Expedited protocols are reviewed by a subset of the IRB consisting of one
faculty member each from the School of Education and the School of Math &
Sciences, plus a faculty member from at least one other school. Full reviews
involve all IRB members.
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4. Q: What criteria are used to evaluate protocols?
A. The IRB uses federal guidelines outlined in the Belmont Report and by the
Office for Human Research Protection (OHRP) to evaluate research protocols. The
actual criteria that are applied differ across the exempt and expedited/full
forms. The differences between the forms are explained in FAQ 5.Office
for Human Research Protections, U.S. Department of Health and Human Services
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5. Q: How do I know which form to use?
A: Depending on the nature of the research, you must submit an exempt,
expedited or full protocol for review. The issue that determines which form you
should submit is the level of risk for potential psychological and/or physical
harm posed to research participants. Greater risk implies the need for a
formalized process for ensuring informed consent from participants and specific
efforts from the researcher to mitigate potential risks.
Exempt protocol: If a study involves independent adult participants and poses
minimal risks (see FAQ 6 for more information on what constitutes a risk), then
the exempt form may be appropriate. If the participants are minors, an exempt
form may be appropriate if the research is conducted in a standard educational
setting and is part of standard educational practices for that setting (see the
exempt form for more information). The exempt form assesses risk through a
series of questions. If your research meets the criteria of minimal risk set
forth in the form, then you may submit the exempt form in order to get your
research approved. Research that presents a minimal risk and falls under the
exempt category usually does not require informed consent and/or assent.
Expedited protocol: If your research exposes participants to potential risks
(either psychological or physical), then you must submit the expedited form.
This form requires researchers to provide detailed information about potential
risks, informed consent procedures, and efforts to mitigate risks to
participant. Keep in mind that questionnaires and interviews often bring up
issues that are emotionally sensitive or threatening to respondents, and
therefore would require careful attention to informed consent procedures,
maintaining confidentiality, and procedures to mitigate risks posed by the
experience. These are the issues addressed by the expedited form.
Full review: Should a study pose significant physical or psychological risk to
participants that can not be readily mitigated, the expedited form is used, but
goes to full review, meaning that all IRB members will meet to review the
protocol. Medical research involving treatments with unknown side effects would
be an example of a protocol requiring full review.
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6. Q: What are possible risks?
A. Risks include anything that can cause emotional distress or physical harm to
the participants. A breach of confidentiality is also a risk. Participants are
at risk if their participation or breach of confidentiality may compromise
their emotional state, physical health, employment or education. Invasion of
privacy, use of personal information, deception and embarrassment are also
potential risks.
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7. Q: What is informed consent?
A: Potential participants must give their informed consent before
participating. Research that presents some risk and requires an expedited or
full review always requires informed consent and/or informed assent. Research
that presents a minimal risk and falls under the exempt category usually does
not require informed consent and/or assent. For a potential participant to give
informed consent, that participant must be given the following information:
1. a fair explanation of the purpose of the study (it is not necessary that you give away
your research hypotheses to the participants up front, but if you withhold this
information, it should be provided afterward in your debriefing).
2. a description of the procedures to be followed
3. a description of potential risks to the participants
4. a description of the potential benefits to the participants
5. a statement that the participant should be at least 18 years of age
6. the researcher's offer to answer any questions about the study
7. an instruction that the participant is free to withdraw from the study and
discontinue participation at any time without penalty
8. instructions that the participant is not required to respond to all
questions in surveys, interviews, etc.
9. a statement that participation is confidential
10. a statement that participation is voluntary
Include all these elements in your consent form or your verbal consent script.
Click here to view a sample consent form.
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8. Q: What is informed assent?
A. Potential participants are often unable to give consent for reasons of
mental state, legal restrictions or age (under 18). In these cases a parent or
legal guardian must give consent. The individual who is a minor can give
assent. Provisions for oral or written assent should include all elements
contained in informed consent.
Click here to view a sample consent/assent form.(Word format)
Click
here to view a consent/assent form template. (Word format)
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9. Q: How can confidentiality be maintained?
A. When participation is confidential it means that the researcher knows the
identity of the participants and can trace information from interviews,
surveys, etc. back to individual participants. The identity of participants and
sources of information are not known to anyone other than the researcher.
Confidentiality can be maintained through the use of pseudonyms or codes to
conceal identity. A researcher can also maintain confidentiality by keeping all
records and identifying information separate from data. It should be noted
that, depending on the number of participants and the demographics of the
group, certain demographic information can reveal the identity of participants.
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10. Q: How are revised protocols handled by the IRB?
A.
Sometimes expedited or full review protocols will receive an "accepted pending
revisions". When this occurs, the researchers should make the changes set forth
by the IRB and resubmit these changes to Ginny Von Behr. Researchers can submit
changed protocols for re-review at any point if they have received an "accepted
pending revisions" notification from the IRB (i.e., they do not have to wait
until the following Wednesday). The IRB chair will review the changed protocols
within 1-2 business days of resubmission and the researcher will be notified if
the changed protocol is accepted. Please note that the researcher cannot begin
to collect data until she/he has received IRB approval of the changed protocol.
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11. Q: What should I include in the brief summary that is to be
attached to my exempt protocol?
A. Keep in mind that the purpose of this
brief summary is to help the IRB assess the extent to which your research
project is actually in compliance with the federal guidelines for exempt
research. Thus, you should describe your research question, describe the
participants (such as who they will be and how you will obtain them), and
briefly describe the research methodology (such as explaining clearly what will
be done to participants and data). Basically, the IRB is looking for more
detail about your study in relation to what you've indicated on your exempt
form. Thus, you should make sure that your responses to questions about
demographics, confidentiality, risk and the identity of your participants on
your form correspond clearly to what you write about in your description.
Additionally, for educational research make sure that your responses to K.1 and
K.2 correspond clearly to what you write about the setting and activities in
the methods used in your study. Also, don't forget to please attach copies of
surveys or interview questions (if applicable to your study).
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12. Q: If I have questions about filling out the appropriate
IRB form and how to create the appropriate consent forms, debriefing scripts,
etc, who do I contact? Can I ask for help from the IRB committee?
A. Yes. The members of the IRB are listed on the home page of the IRB website.
It is suggested that you contact one of the members from your school, since
those members are more likely to be familiar with the issues particular to your
research study. You may also contact the IRB committee by calling the Secretary
for Math and Sciences at 454-5140, and asking to be put in touch with a
committee member from your school.
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