Protocol Guidelines

A protocol is the precise and detailed design for conducting a research study; specifically, it is the study plan submitted to an IRB for review. Because of the ethical concerns of research involving humans, research that is not classified as exempt from federal regulations [45 CFR 46.101 (b) /or 21 CFR 56.104] must be conducted under an IRB-approved protocol. The following guidelines are provided to assist you in writing a complete research study protocol.

1. Table of Contents

It is often useful to provide a table of contents for your protocol, particularly if the content is long and/or complex. A table of contents organizes the information, allowing the user (e.g., the study investigator, the study staff, a Board member, etc.) to quickly access details such as study procedures or study drug storage.

2. Cover Sheet

On the protocol cover sheet, the following information should be provided:

    • Protocol title (usually a short description/explanation of the research study and the drug(s)/device(s) involved).
    • Protocol number (if applicable)
    • Date and version of the protocol
    • IND/IDE number (if applicable)
    • The name and contact information (i.e., address and telephone number) of the Sponsor and/or Monitor.
    • The name and title of the investigator(s) conducting the study (if applicable).
    • The contact information (i.e., address and telephone number) of the site(s) where research may take place with a participant (if applicable).
    • The names of all institutions that are involved with the research study.

3. Introduction

The introduction should provide a basic overview of the proposed study. The following information should be provided in this section:

A. Type of Research
State the type of research the study involves (drug, device, behavioral, registry, etc.).

    • If the study is a drug study, indicate whether an IND has been obtained, or if the drug is exempt from IND requirements [21 CFR 312.2(b)].
    • If the study is a device study, indicate whether the device poses a significant risk (SR) or non-significant risk (NSR) to participants, or if the research use of the device is exempt from IDE regulations [21 CFR 812.2(c)].

B. Purpose/Objective of the Study
State the full and specific scientific purpose of the proposed research and its objective(s)/goal(s).

C. Background of the Study
Provide an introductory overview of any research that is related to the design and conduct of your study, including both human and/or animal research, where appropriate. If new procedures, study medications, or methods are being proposed in the protocol, a description of earlier work in the area of study should be included. The background of the study should be thorough enough so that the basic study design and purpose of research is able to be understood by individuals who may not be experts in the protocol's specific field of study. Cite references as needed.

4. Participant Selection

A. Inclusion and Exclusion Criteria
The inclusion and exclusion criteria are essential elements of the protocol. Inclusion/exclusion criteria scientifically delineate a specific study population and allow a referring doctor to accurately determine whether or not a participant is eligible for a research study. Inclusion and exclusion criteria should be listed separately from each other, and should each be based upon scientifically valid reasons that are directly related to the study protocol. Ultimately, this section should define what objective characteristics a participant should exhibit to be included and excluded from the study.

B. Gender
Equal inclusion of both men and women in a study is important to ensure the equitable sharing of both the potential risks, and the potential benefits that may result from new research. If there are any gender-based enrollment restrictions, explain what these restrictions are and provide a thorough justification for them.

Pregnant women should be excluded from research unless there is a specific justification why they should be included (for instance, if the study relates to the health of pregnant females). Women of childbearing potential, however, should not be excluded. Provide a clear statement concerning the gender distribution of the potential study participants, as well as a clear statement about whether pregnant women are included or excluded from the study.

If women of childbearing potential will be involved in the study, a clear statement about acceptable methods of birth control should be outlined in the protocol. Abstinence, meaning a total lack of any sexual activity, may be an acceptable method of birth control, as well as the use of oral contraceptives (the "pill"), contraceptive injections, intrauterine device, double-barrier method (diaphragm or condom + spermicidal cream), contraceptive patch, or male partner sterilization.

C. Racial/Ethnic Origin
Equal inclusion of a diverse selection of participants from varying racial/ethnic backgrounds in a study is also important to ensure the equitable sharing of both the potential risks and the potential benefits that may result from new research. If there are any racial/ethnic enrollment restrictions, explain what these restrictions are and provide a thorough justification for them. A clear statement on the racial/ethnic distribution of the participants who will be enrolled in the study (taking into account the potentially limited ethnic/racial population of the study site) should be provided.

D. Vulnerable Populations
If any participants that are considered part of a vulnerable population are to be included in the study, thoroughly explain the rationale for the involvement of each class of vulnerable participants. Vulnerable participants include: pregnant women, children, fetuses, wards of the state, cognitively impaired individuals, as well as prisoners and institutionalized individuals. Procedures to minimize a vulnerable participant's susceptibility to being unduly influenced to join a study, as well as procedures to minimize any unnecessary risks (physical, psychological, social, economic, etc.) to the vulnerable participant, must be clearly explained in the protocol [45 CFR 46 (b)(c)(d)].

E. Age
Adult participants should not be restricted from enrollment because of age. If there are any age-based enrollment restrictions, explain what these restrictions are, and provide a thorough scientific or medical justification for them.

F. Total Number of Participants to be Enrolled
State the total number of participants to be enrolled at a study site. If a study will be a multi-center study, provide the number of participants expected to enroll at each specific site, as well as the total number of participants expected to be enrolled in the study as a whole.

5. Study Design / Method / Procedures

A. Summary of the Research Design
Describe and sequentially identify all procedures to be used in the study. These include (but are not limited to):

    • Initial evaluation process
    • Screening tests
    • Study phases
    • Type of design (blind, double blind, genetics, etc.)
    • Time spent by participant at each visit.
    • All procedures that will be performed at each study visit, including procedures that are considered experimental, procedures that would occur normally outside of the research context (such as standard of care), and standard of care procedures that are performed specifically for research purposes (such as extra routine tests).
    • Safety monitoring procedures
    • Dose adjustments
    • Randomization process (if applicable)
    • Criteria (stop points/end points) for withdrawing participants from the study.

Provide a list and description of any alternatives to experimental therapy if they are available, and note any procedures/devices/materials that may pose a risk to the participant's safety.

If applicable, describe how participants who end their participation in the study will be transitioned back to their usual medical care (for instance, participants who need to be returned to normal study medication/treatment after stopping study drug/treatment).

B. Analysis of Study Results
Describe the exact results to be measured and analyzed, including any specific statistical or analytical methods that will be used.

C. Monitoring
If a study involves a separate monitor/monitoring committee, its membership, rules of operation, purpose, and frequency of review, should be described. The following types of studies may especially require a monitor or monitoring committee.

    • A blind or double-blind study
    • A genetics study
    • A study that involves potentially serious risks to the participant.
    • A study that involves a vulnerable population.
    • A study that requires participants to discontinue participation at a certain endpoint.

D. Storage of Data
Describe how all data from the research will be stored (e.g., electronically, in paper files, etc.), who will have access to the data (and for what purposes), and how data will be kept secure. The storage of study data includes both the time period during the study and after the study. Any data management plans, monitoring boards, and/or data management computer programs should be listed.

If biological or genetic samples are to be taken and/or kept for future use, describe plans for storage, use, and management.

E. Confidentiality of Data
It is the investigator's responsibility to keep data gathered from research confidential. Describe methods/procedures for securing the confidentiality of data, including:

    • Procedures for storing data to prevent unauthorized access.
    • Procedures for coding data (e.g., patient's name, randomization number, etc.).

6. Risk/Benefit Assessment

Please note: Although a risk/benefit assessment is a required protocol element, ultimately, Sterling IRB determines the risks and benefits to human research participants.

A. Risks
A protocol must specify whether the risk and discomforts involved are minimal, or greater than minimal. Minimal risk is defined as, "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" [45 CFR 46.102(i) /or 21 CFR 50.3 (k)]. If there are risks involved in the study that a reasonable person would likely consider to be harmful, or that go beyond what is defined as minimal risk in any way, then the protocol poses a greater than minimal risk.

If the risks presented to the enrolled participant will be greater than minimal:

    • Define all such risks. Risks can be physical, social, economic, psychological, and legal.
    • Estimate (if possible), the likelihood of each specific risk, its impact to the participant, and the possible reversibility of specific risks. Provide a justification as to why these risks are acceptable in relation to the possible benefits of the study and its importance to scientific knowledge.
    • Provide a description of any alternative treatments or procedures that are available should the participant choose not to participate in the study, or that may be in the participant's best interest.

B. Prevention of Risks
Describe how the study design, and/or specific procedures, will prevent or minimize potential risks or discomforts to the greatest extent possible. This section will include items that may have been described in earlier sections (e.g., monitoring procedures, participant withdrawal criteria, etc.).

If a placebo is to be used, provide a thorough justification of its importance to the study, especially if there are alternative treatments that may be available to the participant.

C. Adverse Events
Explain what constitutes an adverse event in relationship to the study, as well as the time frame that such events must be reported to the IRB and Sponsor(s). All Serious Adverse Events (SAEs) that are unexpected and related or possibly related to participation in the research should be reported to Sterling IRB within 10 business days of when the site becomes aware of the event. All fatal or life threatening events should be reported immediately to Sterling IRB. Describe provisions for ensuring that medical or professional help is available in case an adverse event occurs.

D. Benefits
Explain any potential medical benefits to a subject participating in the study. If no benefits are expected, this should be clearly stated in the protocol.

7. Participant Recruitment and Informed Consent

A. Recruiting
Explain how the identification and recruitment of participants will take place, along with what information will be provided to prospective participants. This process should not violate a potential participant's privacy, nor be coercive. Examples of coercion include, but are not limited to:

    • An investigator recruiting her/her own students, employees, or patients (though there are certain exceptions where this is not considered coercive).
    • Offering an unjustifiably large amount of money to a participant, such that he/she might be coerced to participate in a study (or continue in a study from which he/she otherwise may have withdrawn).
    • Facilitating the belief that possible benefits of the study are definite.

B. Informed Consent / Assent
The Informed Consent of a participant is the most essential aspect of a research study involving human participation. It is an investigator's legal and ethical responsibility to make sure that a participant, or participant's representative (in the case of minors, or other vulnerable populaces), has sufficient knowledge of a study as it is presented throughout the Informed Consent process. Sufficient information is given to allow the participant to make an informed decision as to whether or not they want to be a participant in the research study. If a study (such as a psychological study) requires any information to be purposely withheld from a participant, state the information that will remain undisclosed, as well as the justification for the non-disclosure, and describe what information will be given to the participant post-study.

Participant Informed Consent/Permission Documents should be written at an 8th grade reading level (or lower) in order to maximize understanding for participants.

Written consent must be obtained for each adult participant in the study, or their legally acceptable representative (LAR). Minors and individuals who are not competent to provide consent should be given the opportunity to assent (affirmational agreement) to participate in the research study.

Sterling's policy is that a separate documented assent must be obtained from all children ages 7–11; verbal assent must be obtained from all minors. The Sponsor may increase the required age range for a separate assent to either younger than 7 or older than 11. All other minors will document assent using the consent form. The Assent Document should be written in language appropriate to the age or cognitive ability of the group giving assent.

Sterling IRB provides descriptive guidelines for writing a Participant Informed Consent/Permission Document and an Assent Document. Sterling IRB also offers a template for both the Participant Informed Consent/Permission documents and Assent Document. Please call 1-888-636-1062 (toll-free) or email us to request a Sterling IRB template.

The proposed Participant Informed Consent/Permission Document and/or Assent Document must be submitted with the protocol.

C. Obtaining and Documenting Consent
For all enrolled participants, the investigator must ensure that a valid Informed Consent /Assent is obtained and documented before any study procedures are performed. The following information should be provided in this section:

    • How the Informed Consent/Permission and/or Assent will be documented.
    • Who will be documenting the Informed Consent (i.e., the person authorized to obtain consent).
    • Where the documentation will be stored.
    • Auditor/Witness roles (if applicable)

D. Participant Comprehension and Capacity
Describe the means that will be taken to determine whether a participant or participant's representative has clearly understood all of the information presented in the Informed Consent (or Permission)/Assent Document(s). This section should provide a detailed plan as to how the investigator will ensure that the participant or participant's representative receives and comprehends the study information prior to the Participant Informed Consent/Permission /or Assent document(s) being signed.

If children or decisionally-impaired adults are to take part in the study, provide a specific plan for assessing their comprehension during the assent process.

E. Costs to Participants
In this section state who or what will be covering the costs of all procedures and necessary follow-ups associated with the study (e.g., sponsor(s), research grant(s), participant insurance plan, etc.).

Normally, participants should not have to pay for any procedures associated with a study (nor any necessary follow-ups). In such cases where the participant will incur financial costs, an explanation and thorough justification of these costs should be provided.

Clearly state if a participant is expected to be covered by his/her own insurance for any procedures.

A participant may not be charged for any costs that are already covered by another person/entity. Participants may not be charged for investigational drugs without the written permission of the U.S. Food and Drug Administration.

F. Compensation to Participants
Participants may receive compensation or payment for their participation in a study. Describe any payments or forms of compensation that participants may receive for participation. The amount of payment/compensation and the proposed method and timing of disbursement must be justified, and must not be coercive nor present undue influence.

Types of compensation include (but are not limited to):

    • Monetary payment
    • Academic credit
    • Coupons/Gift Certificates

List all of the conditions that must be fulfilled by a participant to receive payment (e.g., completing a certain number of visits, arriving at visits on time, etc.).

Generally, payment/compensation should accrue as the study progresses, so that a participant does not have to complete the entire study to receive payment. Furthermore, any amount paid as a bonus for completion must be reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.

8. References

Include selected references which relate to or highlight any information that is pertinent to the study, as well as the study's potential outcomes.

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