Guideline for Writing a Research Protocol – Non-Biomedical
(RSRB Protocol Template Final v. 11/07/2014)
The format and information provided below is provided to assist in writing a protocol (study design) for
social, psychological, and social sciences research. Sections not applicable to the research may be deleted.
Study Title
Principal Investigator – Name and Address
1. STUDY OVERVIEW – PURPOSE AND BACKGROUND
Give a brief overview of your project.
a) What is your purpose in conducting this research? How does the project contribute to the
advancement of knowledge and why is it worth doing?
b) If your study has more than one phase, please clearly map out the different phases.
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. CHARACTERISTICS OF THE RESEARCH POPULATION
2.1. Subject Characteristics
Describe as best you can the population(s) you plan to work with, in the terms that are most
pertinent to your project so the RSRB may understand how working with them will further your
research objectives and what steps need to be taken in order to minimize risk of including this
study population.
a) Number of Subjects: What is the total (maximum) number of subjects to be enrolled (or
their records/specimens accessed) at the University of Rochester (and other institutions if
applicable to a multi-center study)? The total should include the number of evaluable
subjects (i.e., those who meet eligibility criteria), as well as the number of anticipated
screen failures necessary to obtain the enrollment goal. A subject is considered in the total
count once informed consent has been obtained (as applicable). If evaluable subjects who
withdraw from the study will be replaced to meet the enrollment goal, this should also be
stated here.
NOTE: If enrollment will exceed the number for which your study is approved, an amendment must
be submitted and RSRB approval of this amendment obtained before exceeding that number.
b) Gender and Age of Subjects: What is the intended gender distribution and age range of
the subjects? Provide justification for any gender based enrollment restrictions and provide
rationale for the selected age range. Equitable inclusion of both men and women in research
is important to ensure that both receive an equal share of the potential benefits of research
and that neither bears a disproportionate burden. Participation of adult subjects in research
should not be age-restricted unless there is scientific justification.
NOTE: The age of majority in New York State is 18. Special considerations apply to research with
children.
c) Racial and Ethnic Origin: What is the intended racial and ethnic distribution of the
subjects? Provide justification for any enrollment restrictions based upon race or ethnic
origin.
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NOTE: Within the limitations imposed by the population of the study site(s) and the purpose of the
study, research should include sufficient enrollment of persons of diverse racial/ethnic backgrounds to
ensure that the benefits and burdens of research participation are distributed in an equitable manner.]
d) Vulnerable Subjects [Remove section if not applicable]: What is the justification for
inclusion of subjects who are vulnerable to coercion or undue influence (e.g., children,
pregnant women, the elderly, students, employees, fetuses, prisoners and persons with
decisional impairments)? What are the additional safeguards that will be applied to protect
their rights and welfare?
2.2. Inclusion and Exclusion Criteria
NOTE: Enrolling a person who does not fit eligibility criteria listed here is a protocol violation and requires
notification to RSRB as a reportable event.
a) Inclusion Criteria: List (in bullets) the criteria that each subject must satisfy to enter the
study. Define the eligible subject population in terms of age, sex, race (as appropriate),
diagnosis requirements, method of diagnosis, ability to perform study-related functions, and
the ability to give informed consent.
b) Exclusion Criteria: List (in bullets) the criteria that will prevent inclusion of an
inappropriate subject into the trial. Consider existing or previous conditions, disorders or
disabilities, cognitive functioning, pregnancy.
NOTE: Women of childbearing potential may not be routinely excluded from participating.
3. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT
3.1. Method Of Subject Identification And Recruitment
How will subjects be identified and selected for the study and how will privacy of the
individuals be maintained? Are there specific populations that you will be targeting and if so,
why? Are there potential subjects that you will exclude from the study and if so, why?
The identification and recruitment of subjects must protect privacy and be free of undue
influence. Only research personnel with routine access to prospective subjects (or subject
records) may recruit those individuals directly (“routine access” meaning the investigator
already has a clinical/academic reason to know/review a study/patient’s record or is known to
the prospective subject). Research personnel who do not have routine access to prospective
subjects may not contact subjects directly (i.e., no “cold calls”); they must work through the
individual(s) with routine access.
Please provide all materials used to contact subjects in this study. These materials could
include letters, emails, flyers, advertisements, social media sites, etc. If you will contact
subjects verbally, include the recruitment script in the RSRB application Section 66.1.
NOTE: Recruitment of an investigator’s own students, employees or patients is considered potentially
coercive. Steps taken to minimize undue influence should be included in the study protocol.
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3.2. Process of Consent
Consent is an on-going process that starts when you first inform potential subjects about the
study and ends when the subject’s study participation is completed.
a) What is your method for providing information about the study to the potential subject
(e.g., consent form, assent form, information letter, oral script) and documenting that
consent was obtained? Is a waiver of consent or a waiver of documentation of consent
being requested for part or all of the study? If so, provide justification. Who will present
the study information and how will it be presented (note that all research personnel
involved in the consent process should be listed on the RSRB application Section 1.6
and/or Sect. 85.1)? If applicable, describe under what conditions a witness or translator will
be used.
b) Vulnerable Populations [Remove section if not applicable]: What is the plan to assess
subject comprehension during consent or assent (the subject’s agreement) when inclusion
of children, pregnant woman, prisoners or subjects with diminished capacity are proposed
for the research? If subjects will be capable of providing initial consent to enroll, but will
possibly or probably lose that capacity as the study progresses, provide provisions for the
subject to designate an authorized representative or research proxy. See OHSP policies
regarding review of research requiring special consideration.
c) Deception/Withholding [Remove section if not applicable]: If applicable, justify why
deception and/or withholding information from subjects is necessary and describe the
deception and post-study debriefing.
Deception: Intentionally misleading research subjects or withholding full information about the
nature of the experiment. When a subject is purposefully and deliberately misled about the purpose
of the research or the procedures, then the subject is being deceived.
4. METHODS AND STUDY PROCEDURES
The manner in which the data are collected, how they are stored, and how the data are reported in
your research is an important part of determining the risk to subjects. When developing study
procedures, consider minimizing or eliminating the collection of identifying information where
possible and provide justification as to why it needs to be collected.
4.1. Study Procedures and Assessments
Describe procedures/assessments/measures/experiments that will be performed to meet the
study objective(s), indicating who is responsible for performing the activities (e.g., Investigator,
Coordinator, Subject, Counselor, etc.) and the location (facility or institution) where the
research activities will be conducted. If home visits will be conducted, ensure the procedures in
the Guideline for Conducting Home Visits are addressed. Will you use audio recordings,
photographs, video recordings or other similar data recording devices? If so, justify why it is
necessary to use these devices, how you will use them, and what you will do with the data after
they are collected. Procedures/tests/interventions which are performed exclusively for research
purposes must be identified and differentiated from that which would occur regardless of the
research (i.e., routine clinical standard of care or classroom instruction procedures).
4.2. Data & Specimen Banking for Future Research Use [Remove section if not applicable]
Will data and/or specimens be banked for future research use? What is the purpose for storing
the data/specimens, the type of research that will be conducted with the data/specimens, where
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the data/specimens will be stored, who will have access to the data/specimens, and the
conditions (if any) under which they will be released to investigators outside the study team?
How long will the data/specimens will be stored and will it be destroyed at any time point?
What are the procedures for maintaining confidentiality of subject information (i.e. will the
data/samples be coded to allow subjects to be identified)? Will subjects be able to withdraw the
sample and/or data and what is the process for doing so? Will subjects be re-contacted
regarding the banked data/specimens?
4.3. Costs to the Subject [Remove section if not applicable]
What are the costs (i.e., study procedure and/or standard of care) that the subject, or the
subject’s insurance, may incur as a result of participating in the study? Who will pay for
procedures associated with the study (e.g., agency grant versus departmental funds)? No
charge may be made to subject if the study costs are already covered by a grant, contract, or
other payment method.
4.4. Payment for Participation
Are there any reimbursements or payments (e.g., cash payments, coupons, course credit) that
the subjects will receive for participation? What are the condition(s) that must be fulfilled by
subjects to receive these payments? The amount must be justified and not constitute undue
inducement of the subject to participate in the research or to continue beyond a point that they
would have otherwise withdrawn. If there are no payments for participation planned, state that
in this section.
NOTE: The RSRB requires a prorated system for financial payments. This means that payments are accrued
as the study progresses and that subjects do not have to complete the entire study to be eligible to receive a
payment. This is to protect the subject’s right to withdraw without penalty.
4.5. Return of Individual Research Results [Remove section if not applicable]
Will research results be provided back to the subject (e.g., research test results, psychological or
neurological assessment results, genetic test results), and if so, when they will be provided (e.g.,
not until the study is completed, at the time the Investigator receives the result, etc)? How will
incidental findings that might have health consequences for the individual subject be managed?
5. SUBJECT WITHDRAWALS [Remove section if not applicable]
Subjects will be advised during the consent process that they have the right to withdraw from the
study at any time without prejudice. If applicable, describe anticipated circumstances under which
subjects will be withdrawn from the research without their consent (e.g., non-compliance, termination
of funding, failure to continue to meet inclusion criteria).
6. REPORTABLE EVENTS [Remove section if not applicable]
Describe the process for reporting any symptom, sign, illness, or experience that occurs (or worsens)
during the course of the study, whether subject reported or by assessment of study assessments or
labs. The study period for reporting study events (e.g., from the time of signing consent to final study
visit) should be indicated, who needs to be notified and the time frame for notification, as applicable.
If there are any specific reporting forms to be completed, this should be indicated here.
7. RISK/BENEFIT ASSESSMENT
Almost any intervention into other people’s lives carries with it the potential to cause them social,
psychological, sociological, economic, physical, or legal harm. However, not every interaction will
put a subject at risk beyond what is considered minimal. Consider the following information when
describing the potential risks and benefits to the subjects:
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7.1. Risks to Subjects
 Describe the risks to subjects in your study including any potential risks to individuals
other than the subject. Risks are not only physical, but psychological, sociological,
economic and legal as well.
 How will the study design prevent and/or minimize any potential risks or discomfort (e.g.,
procedures such as appropriate training of personnel, monitoring, or withdrawal of the
subject upon evidence of difficulty or adverse event; referral for treatment, counseling or
other necessary follow-up)? Indicate the process for managing any additional medical
evaluations or treatments that may be deemed necessary. Indicate whether referrals will be
made (e.g., if a harmful situation occurs, medical condition discovered).
 Describe what you will do to minimize those risks. Describe what you will do if a harmful
situation occurs.
 Would a loss of confidentiality of any of your materials put subjects at risk? If so, how will
you prevent this from happening?
 Will information be obtained during the conduct of the study that would require mandated
reporting (e.g., Department of Health Services)? Will a Certificate of Confidentiality
(COC) be included to conduct the study and what is the justification for use of the COC?
7.2. Benefits to Subjects
Benefits help to outweigh the risks to subject, though not every study will have direct benefits
to the subjects. Will there be any direct benefits to the subjects in your study? If so, what are
they? Do not include subject payments or benefits to society or others. If there are no
anticipated benefits, this should be stated.
7.3. Alternatives to Participation
Are there any alternative courses of action which are available should the subject elect not to
participate in the study? If the subjects are students who will receive academic credit for
participation, what are the alternatives available to earn equivalent academic credit? Academic
alternatives must be approximately equal in time and effort required. If there are no
alternatives, this should be stated.
8. CONFIDENTIALIATY OF DATA AND INFORMATION STORAGE
Confidentiality is the ethical and/or legal right that information, such as research data, will be held
secret and safeguarded from disclosure unless consent is provided permitting disclosure.
Private information includes information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, and information
which has been provided for specific purposes by an individual and which the individual can
reasonably expect will not be made public (for example, a medical record).
What will you do to protect the privacy and confidentiality of your subjects? Will subject data be
identified in the research data set with a random sequential numbering or unique identifiable code (a
random unique code is not considered an individual identifier if the code is not derived from or
related to the information about the individual, could not be translated to identify the individual, and
the key is securely retained)? How will research samples be labeled (e.g., the same subject ID
number, barcode, etc.)? How you will protect against disclosure of any individual subject identifiers
that are collected?
How will your materials be stored (includes coding data and choosing an appropriate and secure data
storage mechanism which will prevent unauthorized access to data)? Discuss both how you plan to
store it while you are collecting and actively analyzing it, who will have access to the data, and your
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long-term plan for maintaining it when the active research phase is finished. If internet based research
is planned within the protocol, the level of encryption used by the online survey tool must be
described as a protection against the risks of loss of confidentiality (see Guideline on Computer and
Internet Based Research). How will your data be reported in your study? Will you report the results
in aggregate or will individual data be discussed? If you are storing electronic files, make sure that
your data storage plan complies with University IT policies.
NOTE: To ensure adequate encryption of files stored on portable devices such as laptops, tablets, memory
sticks, etc., contact Information Technology (URMC website or UR website). For instruction regarding
encryption of emails containing PHI see the Information Systems Email guidance. For information regarding
maintaining subject privacy, the HIPAA website provides frequently asked questions, or contact the HIPAA
privacy officer for assistance.
Examples for maintaining confidentiality of data and protecting against unauthorized disclosure
include:
 not storing identifying information in the research database (i.e., keep any identifying information
separately from the research database and use a subject ID number)
 assign a random unique code to each subject (see definition of random unique code above)
 locking research files while they are unsupervised
 using screensavers
 using acceptable methods of data storage (e.g., server, encrypted CD or DVD, network drive)
 shredding excess copies of paper documents
 protections for codes that link subjects to their data
 electronic and physical security of data storage devices and networks (i.e., encryption)
9. RESEARCH INFORMATION IN MEDICAL RECORDS
Indicate if any research data will be included in the subject’s medical record (e.g., indication of study
participation, copy of signed consent, research test results).
10. DATA ANALYSIS AND DATA MONITORING
10.1. Planned Statistical Analysis
What are the statistical/analytical methods to be used for the collected research data and to meet
the goals of any specific endpoints that will be analyzed?
10.2. Data and Safety Monitoring
See OHSP Data and Safety Monitoring Plan policy for more information regarding data
monitoring requirements that may be applicable to this study (i.e., this section may not apply to
studies qualifying for exemption). A data and safety monitoring plan must be established
appropriate to the nature, size, and complexity of the protocol. A plan is developed to assure
that an adequate process is in place for the appropriate oversight and monitoring of study
progress to ensure: 1) the safety and welfare of subjects, and 2) the continued validity, scientific
merit and integrity of the data. Data and safety monitoring of the study may be in the form of
the Investigator or other assigned study personnel reviewing data on a specified interval to an
established monitoring committee. If a Data and Safety Monitoring Committee is used, the
plan should provide a detailed description of the operations of the committee or board (i.e.,
membership, function, frequency of review, stopping rules).
11. REFERENCES
Provide complete, numbered references for all citations listed in the order that they appear.
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