Protocol Template for Minimal Risk Studies not Regulated by FDA
INSTRUCTIONS:
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You may use this document as a guide to write a protocol.
You do not need to follow this document. You may use a different
format, order, outline or template provided the necessary information is
included.
Depending on the nature of what you are doing, some sections may
not be applicable to your research. If so, delete them.
For simple research, such as a retrospective chart review, less than a
page may be necessary to address the relevant sections.
If you use this template, delete the instructions.
If you already have a protocol:
o Review this document to ensure that the protocol addresses the
relevant information and add missing information.
o If you cannot add missing information to the protocol, provide the
information in a separate document.
o Do not duplicate information already present in the protocol.
1) Abstract of the study
Provide a summary of the study (recommended length: 250 words).
2) Protocol Title
Include the full protocol title as listed on the Application for Human
Research.
3) Investigator
Include the principal investigator’s name as listed on the Application for
Human Research.
4) Objectives
Describe the study’s purpose, specific aims, or objectives.
State the hypotheses to be tested.
5) Rationale and Significance
Describe the relevant prior research experience and the gaps in
current knowledge.
Describe any relevant preliminary data.
Describe how this research study will add to existing knowledge.
6) Resources and Setting
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Protocol Template for Minimal Risk Studies not Regulated by FDA
Note that the City of Philadelphia’s IRB may also require approval of
your study. Please contact its website for specific information:
http://www.phila.gov/health/commissioner/IRB.html
Beyond the required CITI training, describe how the investigator has
ensured that all persons assisting with the study are adequately
informed about the protocol and their study-related duties and
functions.
Describe the study facilities, including the site(s) where your research
team will identify and recruit potential subjects and the site(s) where your
research procedures will be performed.
7) Prior Approvals
Describe any non-IRB approvals that will be obtained prior to
commencing the research. (e.g., school, external site, or funding
agency).
8) Study Design
a) Recruitment Methods
Describe how many subjects will be needed.
Describe when, where, and how potential subjects will be identified
and recruited.
Describe materials that will be used to recruit subjects, e.g.,
advertisements.
Describe any payments to subjects, including the amount, timing (at
the end of the study or pro-rated for partial study participation),
method (e.g., cash, check, gift card), and whether subjects will
experience a delay in receiving the payment.
b) Inclusion and Exclusion Criteria
Describe the criteria that determine who will be included or
excluded in the study.
c) Study Timelines
Describe:
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The duration of a subject’s participation in the study.
The duration anticipated to enroll all subjects.
The estimated date that the investigators will complete the
study.
d) Study Procedures and Data Analysis
Describe the study procedures and how the data will be analyzed.
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e) Withdrawal of Subjects
Describe any anticipated circumstances under which subjects will
be withdrawn from the research without their consent.
Describe the consequences of a subject's decision to withdraw from
the research and the procedures for orderly termination of participation
by the subject (e.g., the subject contacting the investigator for an endof-study visit).
f) Privacy & Confidentiality
Describe whether the study will use or disclose subjects’ Protected
Health Information (PHI).
If the study uses or discloses PHI, the PI must do one of the following:
Submit a “HIPAA Authorization English (HRP-505)” or justify a waiver
of HIPAA authorization. The criteria for a waiver of HIPAA
authorization can be found in the “WORKSHEET: HIPAA Waiver of
Authorization (HRP-428).”
Additional information regarding PHI and HIPAA can be found in the
“references” section of the Temple IRB website.
Describe the steps that will be taken to secure the data (e.g., training,
authorization of access, password protection, encryption, physical
controls, Certificates of Confidentiality, and separation of identifiers
and data).
Describe whether results (study results or individual subject results,
such as results of genetic tests or incidental findings) will be shared
with subjects or others (e.g., the subject’s professor, teacher, advisor,
counselor, or primary care physician) and if so, describe how it will be
shared.
Describe the steps that will be taken to protect subjects’ privacy
interests. “Privacy interest” refers to a person’s desire to place limits on
whom they interact with or whom they provide personal information to.
Describe the steps that you will take to make the subjects feel at ease
with the research situation in terms of the questions being asked and
the procedures being performed. “At ease” does not refer to physical
discomfort, but the sense of intrusiveness a subject might experience
in response to questions, examinations, and procedures.
9) Risks to Subjects
List the reasonably foreseeable risks, discomforts, hazards, or
inconveniences to the subjects that are related to a subject’s
participation in the research. Consider the probability, magnitude,
duration, and reversibility of the risks. In addition, consider physical,
psychological, social, legal, and economic risks.
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Describe the procedures that will be taken to lessen the probability or
magnitude of risks.
If applicable, describe risks to others who are not subjects.
Describe the availability of medical or psychological resources that
subjects might need as a result of anticipated consequences of the
research.
10)
Potential Benefits to Subjects
Describe the potential benefits that individual subjects (i.e., not society)
may experience from taking part in the research or indicate that there
is no direct benefit.
11)
Costs to Subjects
Describe any costs that subjects may be financially responsible for due to
study participation.
12)
Informed Consent
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Indicate whether you will follow “INVESTIGATOR GUIDANCE:
Informed Consent (HRP-802).”
If not, provide a description of your consent process including:
o Where will the consent process take place
o Any waiting period available between informing the
prospective subject and obtaining the consent.
o Any process to ensure ongoing consent.
o The role of the individuals listed in the application as being
involved in the consent process.
o The time that will be devoted to the consent discussion.
o Steps that will be taken to minimize the possibility of
coercion or undue influence.
o Steps that will be taken to ensure the subjects’
understanding.
Non-English Speaking Subjects
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Indicate the language(s), other than English, that are
understood by prospective subjects or representatives.
If subjects who do not speak English will be enrolled, describe
the process to ensure that the oral and written information
provided to those subjects will be in that language.
Waiver or Alteration of the Consent Process (consent will not
be obtained, required information will not be disclosed, or the
research involves deception)
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Review the “CHECKLIST: Waiver of Consent HHS (HRP-300)”
to ensure you have provided sufficient information for the IRB to
make these determinations.
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If the Human Research involves a waiver of the consent
process for planned emergency research, please review the
“CHECKLIST: Waiver of Consent Emergency Research (HRP301)” to ensure you have provided sufficient information for the
IRB to make this determination.
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If the Human Research involves a waiver of the consent
process that includes use or disclosure of protected health
information (PHI), please review the “WORKSHEET: HIPAA
Waiver of Authorization (HRP-428)” to ensure that you have
provided sufficient information for the IRB to make these
determinations.
Subjects who are not yet adults (infants, children, teenagers)
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Describe whether parental permission will be obtained from:
o Both parents unless one parent is deceased, unknown,
incompetent, or not reasonably available, or when only one
parent has legal responsibility for the care and custody of the
child.
o One parent even if the other parent is alive, known,
competent, reasonably available, and shares legal
responsibility for the care and custody of the child.
Describe whether permission will be obtained from individuals
other than parents, and if so, who will be allowed to provide
permission. Describe the process used to determine these
individuals’ authority to consent to each child’s general medical
care.
Indicate whether assent will be obtained from all, some, or none
of the children. If assent will be obtained from some children,
indicate which children will be required to assent.
When assent of children is obtained, describe whether and how
it will be documented.
Cognitively Impaired Adults
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Describe the process to determine whether an individual is
capable of consent.
Adults Unable to Consent
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For research conducted in the state, indicate you will follow
“POLICY: Legally Authorized Representatives Children and
Guardians (HRP-021)”
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For research conducted out of the state list the individuals from
whom permission will be obtained in order of priority. (e.g.,
durable power of attorney for health care, court-appointed
guardian for health care decisions, spouse, and adult child.)
Describe the process for assent of the subjects. Indicate
whether:
o Assent will be required of all, some, or none of the subjects.
If some, indicate which subjects will be required to assent
and which will not.
o If assent will not be obtained from some or all subjects,
submit an explanation.
o Describe whether assent of the subjects will be documented
and the process to document assent.
Vulnerable Populations
If the Human Research involves individuals who are vulnerable to
coercion or undue influence, describe additional safeguards to protect
their rights and welfare.
Indicate whether you will include any of the following populations:
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Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
If the Human Research involves cognitively impaired adults, review the
“WORKSHEET: Adults Lacking Capacity (HRP-414)” to ensure you
have provided sufficient information for the IRB.
If the Human Research involves persons who have not attained the
legal age for consent to treatments or procedures involved in the
research (“children”), review the “CHECKLIST: Children (HRP-310)” to
ensure you have provided sufficient information for the IRB.
If the Human Research involves pregnant women, review the
“CHECKLIST: Pregnant Women (HRP-305)” to ensure you have
provided sufficient information for the IRB.
If the Human Research involves prisoners, review the “CHECKLIST:
Prisoners (HRP-308)” to ensure you have provided sufficient
information for the IRB.
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