Instructions for Completing the Tulane IRB Protocol Template
IMPORTANT – Please review the following as you prepare the protocol:
Note: A Protocol is REQUIRED when submitting an Initial Submission to Tulane University HRPO;
however, this format is NOT required, this format is recommended and to be used as guidance when
formulating a protocol.
If a sponsor protocol is submitted, this document is NOT needed. Any changes to the IRB
Approved Protocol must be submitted as an Amendment, reviewed and approved by the Tulane
IRB before initiation.
The major responsibility of the Committee for the Protection of Human Subjects is to review research
protocols and informed consent documents to ensure that risks to human subjects are minimized and
that the procedures and risks are clearly presented to the subjects. These requirements are based on
the Code of Federal Regulations 45 CFR Part 46.
Delete this instruction page and any template language in the final document.
If you have questions concerning use of the template or need assistance, please contact the Tulane
HRPO at 504-988-2665 or irbmain@tulane.edu.
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Study Title:
1. Study aim, background, and design
This section generally requires only 2 to 4 paragraphs. Clarify and condense the research
aim, purpose and design. This should be understandable to the layperson; do not use
discipline-specific jargon, acronyms or technical terms without defining them. Explain the
methodology. Describe how you will analyze the data. Will your data fulfill the research
purpose or answer the research question?
2. Subject Population
What inclusion/exclusion criteria are there for subjects? Why is this particular set of subjects
being recruited? How many subjects will there be?
If children are involved, (under 18) parental consent to participate in research will be necessary,
and a minor assent if the child is between 7 and 13 of age.
If other vulnerable subjects will be involved such as pregnant women, prisoners, cognitively
impaired subjects, etc, a rationale for their inclusion must be given.
How will recruitment take place? If the researcher will recruit participants in person or over the
telephone, we need to see a recruiting “script” to ensure that the researcher is not being
inadvertently coercive. The recruitment should be strictly an invitation to participate in a
research study.
If the researcher is using flyers or an advertisement to recruit subjects, the IRB needs to
approve the materials before they are posted or submitted for publication. If subjects are
recruited through a class, we need the instructor’s permission. Will the researcher use
personal contacts to recruit?
3. Procedure
These need to be detailed, but as clear, concise and brief as possible, attempt to use a
bulleted list format. If the researcher will audiotape the interviews, he/she should include that
information in this section.
Once the procedures are listed, state how long they will take. Give both a total time
commitment for the subject, and also break down the time for each step of the procedure.
Where will the research occur? What time of day?
A copy of all research materials/data collection tools must be submitted such as
questionnaires, surveys, focus group guides, or interview questions to be used. If the
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research activity will take place during class time, how will the regular work be made up? If
done for extra credit, the researcher must present alternatives for earning extra credit for those
students who do not wish to participate in the study.
4. Risks
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risk can be psychological (anxiety, depression), emotional (anger, sadness, fear), stress,
discomfort, or inconvenience. In most cases, the main risk could be loss of the subjects’
privacy, if the subjects can be identified in any way.
When the research raises the possibility of a risk in this section, he/she must then state how the
risk will be minimized. For instance, if loss of privacy is a possible risk, state how the subjects’
privacy will be protected, i.e., by using code names and keeping them separate from the data,
or by conducting a survey without names.
Once the data has been collected, how will the confidentiality of the data be protected? Will the
research material be locked in a secure room or cabinet? Will information be coded and only
the researcher will have the code? Will only the researcher or research team have access to
the data? Also, state what will happen with the raw data.
If inconvenience is the issue, state that the activity will be arranged to occur at a time and place
convenient to the subjects, or that research will be conducted after work or school, or
transportation will be arranged.
Discomfort can occur when a subject is asked to relive an uncomfortable time in his/her life, or
is asked potentially sensitive questions. Being observed can make individuals uncomfortable.
Being singled out in a class can be uncomfortable. More seriously, letting a superior have
access to an evaluation of your job performance can be risky. Admitting in an interview that you
are not doing your job, or that you use drugs, or that you think your boss is incompetent, could
be very risky to your employment status, if there is a chance your employer could find out.
Letting a researcher have access to school records may embarrass a child if damaging
information is revealed. Other risks may be far more obvious. Minimizing the risks in these
sensitive situations usually involves participants having the choice NOT to answer questions if
they choose not to or having the ability to withdraw from the study at any time without penalty.
Group discussions, or focus groups, contain an added risk of loss of privacy, because the
nature of the discussion process is such that the researcher cannot guarantee that participants
will not talk about what took place in the group once the group has dispersed. The “extra
privacy protection for focus groups” is that the researcher will discuss the need for keeping the
proceedings confidential with the group at the beginning, throughout the process, and again at
the end. A paragraph stating this should be included in protocols and consents for focus group
subjects. Some researchers ask the participants to sign a brief statement that they will not
discuss what happened in the group outside of the group. Possible loss of privacy is almost
always a concern in the kinds of research done at Tulane University. Consider the ways in
which this might happen: poor test results are revealed, survey answers can be identified if the
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participants’ names are written on the survey, private information revealed in group discussions
can become a source of gossip. All of these could be at the very least embarrassing for a
participant. The researcher’s responsibility is to take steps to protect the participants’ privacy,
and to state how that will be done in the protocol and the consent documents.
The researcher should also state how the confidentiality of the data will be maintained, for
instance, a survey will be posted online through a third party like Survey Monkey, so that email
addresses or web URLs will not be noted by the researcher. Or, the data will be kept in a
locked cabinet or office, and the original material will be kept for the duration of the study then
destroyed, or all identifiers will be removed and the data will be kept for a number of years in a
safe place, or archived in a safe place (describe).
Include the ultimate fate of the data, especially audio and videotapes. (A common procedure
with tapes is to keep them locked in a secure place for one year after the study, and then
destroy them or erase them. This must be included in the risks section.) Transcripts of the
tapes may be kept with identifiers removed. Studies in which audio and/or videotapes are
utilized are not eligible for exempt status. Such studies will be considered for expedited
review.
If the researcher intends to use the data later in conjunction with another study, the
consent form must reflect this. The usual wording is: “The data will be retained by the
researcher without identifiers for possible use in a future project, which will be consistent with
the original research purpose.”
5. Benefits
Research does not need to have direct or guaranteed benefits to the subjects to be approved.
“Benefits” are very specific, such as a particular drug treatment or therapy for the research
subject, or that their medical costs will be paid. Remote possibilities or potential altruistic value
should not be stated as benefits. There is a standard line that should be use here: “There will
be no direct benefits to subjects for participating in this research, but the knowledge gained from
the study may benefit society in general.”
If you want to mention anticipated benefits, use the conditional tense, because you cannot
guarantee that these benefits will happen until the research has been completed and the data
analyzed. For instance, say that “Anticipated benefits might include a participant’s greater
understanding of this subject matter.”
Note: Payments in return for participation cannot be included as a benefit of participating in the
research.
6. Remuneration
This includes cash payments, gift certificates or anything else a researcher might give subjects
in exchange for their participation in a research study.
If there will be remuneration, state what it is and the payment schedule to be followed.
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If there will be none, state that: There will be no payment for participation in this research study.
7. Academic or Extra Credit
If subjects will receive academic credit or extra credit for participating in the research study,
state that here. In addition, state that alternative methods of earning extra credit will be made
available to those who do not want to participate in the research study. If this is not applicable
to your project, write “NA” or do not include this section.
8. Costs
If there are costs, state them: “Subject will be required to pay for transportation to the research
location, and parking.”
If there will be no costs to the participant, state that: “There will be no costs to the subject for
participating in this research study.”
9. Alternatives
If the researcher is proposing a treatment or therapy, a disclosure of appropriate alternative
courses or treatment that might be advantageous to the subject, if any, is required here.
Generally, the alternative is that the subjects do not have to participate in the research.
10. Consent process and documentation
Research needs some form of informed consent to the procedures from the human
subjects, in accordance with the Belmont Report.
Obtaining informed consent is a process, not just a document. The consent process begins with
the recruitment of participants, and continues with a full description of the research purpose and
personnel, procedures, risks and benefits, and the reiteration that research is voluntary. If the
risks change during the course of the project, it may be necessary to re-consent the participants
to ensure they are fully informed and still agree to participate.
Consent to participate in a research project is generally documented by a signed consent form.
The IRB must approve the final consent form that will be presented to the participants. Do not
have anyone sign the consent until you have received an official letter of approval from the IRB
office. The researcher is obligated to keep them for at least three years, or more as determined
by their discipline. If a researcher is conducting a telephone survey, verbal consent may be
obtained, and the IRB must approve the telephone script.
Written consent is waived under very specific circumstances, as when the existence of a written
consent document itself is the only material linking the subject to information that may cause
loss of employment, life, or reputation.
11. Qualifications of the investigators
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Student qualifications should include any relevant work, volunteer or research experience. Any
life qualifications are also useful to know, such as:
The researcher is a member of the group he/she wishes to study and has insight into the
question being investigated, or
The researcher has had experience with sensitive interviews as a social worker, or
The researcher is certified in a particular field, or
The researcher has volunteered with the organization being studied, etc.
Sometimes the addition of investigator qualifications makes the difference in getting approval for
participant contact that may otherwise be too risky, for either the subjects or the student
investigator.
Also mention the supervising instructor’s qualifications, i.e., a full/associate/assistant professor
at TU; PhD in ___, x years of experience as a researcher in the field.
Faculty and staff qualifications should be stated concisely and clearly.
12. References
Some ongoing faculty research protocols may require lengthy bibliographies, but most student
research requires no more than 10 bibliographical references. Be sure that any sources cited in
the Study Aim, Background and Design section are included in your bibliography. Conversely,
make sure that you have included references in this section that support your hypothesis or
research purpose.
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