Guideline for Writing a Protocol – Exemption Requests
(RSRB Protocol Template Final v. 11/07/2014)
IMPORTANT NOTE: If it is determined that your study does not meet the review level of exempt, additional protocol
elements may be required. Refer to the Guideline for Exempt Status Determination for activities that may qualify for
exemption.
For record/specimen reviews, see the Protocol Template – Specimen and Record Review.
Title:
Principal Investigator/Advisor:
1. Purpose of the Study:
State the purpose of the study.
NOTE: Investigators conducting research in foreign countries should refer to the Guideline for Conducting
International Research to ensure that items are addressed and additional protocol elements are considered
and adequately described.
2. Background:
What is your research topic and question? What is the justification and rationale for the proposed
study? If known, provide a summary of prior experience and/or history important to understand
the proposed study. Include any relevant literature citations.
3. Study Population:
 How many subjects/records are needed to conduct the study? Is the number an appropriate size
to achieve meaningful scientific and statistical results?
 What is the gender and/or age range of subjects?
 What are the inclusion and exclusion criteria that define who will be eligible and who will not
be eligible for the study (should support the purpose of the study)?
o If vulnerable populations are included (e.g. children, elderly, students, employees, persons
with decisional incapacity), provide justification for inclusion and any extra protections in
place, e.g.,
 Students –
 Professors not involved in requesting participation.
 Students who receive extra credit for participation in research must have the option
of earning extra credit through an alternative route. For example, professors can
provide assignments with a research focus that involve about the same investment in
time per point as participation in the research. The protocol must explain how
students are notified of this alternative method of obtaining credit. If the subject
chooses to exit the study before completion, the extra credit points must still be
provided.
 Employees – supervisors not involved in requesting participation
 Persons with decisional incapacity – authorized representatives involved in requesting
participation
 For Mechanical Turk (Mturk) users, will subjects be tracked by Human Intelligence Tasks
(HIT) completed or by worker ID #? Tracking by HITs may account for fewer subjects
completing multiple HITs, whereas tracking by worker ID # will indicate the actual number of
subjects participating.
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4. Recruitment:
 How will subjects be identified (e.g. flyers, emails, websites, announcements (e.g., schools),
SONA listing, Mechanical Turk)? Does the study team have routine access to the potential
subjects being recruited and/or data being reviewed? If not, how will the study team recruit
subjects or obtain the data? If a secondary analysis of pre-existing data, indicate the database to
be used or where the data is coming from and how eligible subjects will be identified from the
database.
 What is the process for determining a subject’s willingness to participate and the method for
documenting, e.g.,
o Information letter and completing the survey
o Consent form/assent/parent permission
o Note: If a secondary analysis of pre-existing data, it is not necessary to include information
about determination and documentation of a subject’s willingness to participate.
5. Study Activities:
 Provide a detailed description of all study activities:
o What is the duration of the study (e.g., one semester, one year, until enrollment is reached)?
o Who will conduct each activity (e.g., session, focus group, interview, experiment)?
o How long will each activity (e.g., session, focus group, interview, experiment) take?
o Where will the study activities (e.g., session, focus group, interview, experiment) take
place?
o If the study involves more than one visit, provide a sequential description of each study
visit including what will occur at each visit and how long each visit will take.
 What type of compensation will be provided to subjects (e.g., class credit, Mechanical Turk
payments, or no compensation will be provided)? If using SONA, indicate whether identifiers
will be used to track payment for class credit and whether or not research data will be linked to
payment information/identifiers.
6. Risks and Benefits of Participation:
a) Risks: What are the potential risks of each study activity? Risks can be physical,
psychological, sociological, economical or legal. How will any risks be minimized (e.g.,
referral to University Counseling Center at 275-3113)?
b) Benefits: What are the possible benefits from participation in the research? If there are no
possible benefits, state no benefit. Please note: Payment is not a benefit.
7. Data Analysis:
What are the statistical methods that will be used to analyze the data obtained during the study?
8. Data Storage and Confidentiality:
Where will research data be stored and who will have access to the data? How will the stored data
be identified? Note: UR data security requirements must be followed
(http://www.rochester.edu/it/policy/index.html and
http://www.rochester.edu/it/policy/MobileDevice.html)
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