Guidance Sheet: Completing the IRB Review Form

In most cases the IRB will need four documents to use in its review of a research project (submitted as pdf, doc, or docx files only, no zipped files, please):

• The IRB Review Form. Download that form (click here). Detailed instructions for completing that form are listed below.
• The consent form you will be using for your study.
• For self-report studies (surveys, interviews), verbatim copies of all survey items and interview questions
• Recruitment Information: If you plan to recruit subjects via email, Spiderbytes, SONA, and so on, verbatim copies of recruiting materials are required

After downloading and opening the IRB Review Form for editing, refer to this page for information about the information needed for each section of the form.

Section One: Investigator Information

This section of the Review Form asks you to provide some background information about the individuals who are conducting the project. Note that all individuals identified as engaged in the research should complete the CITI training in the projection and welfare of human participants in research before you submit this form.

1-1. Date of submission:

Protocols should be sent directly to IRB@richmond.edu. Most studies can be reviewed within one week of receipt, but protocols requiring review by the convened board should be submitted by the deadline posted on the IRB webpage and announced via Spiderbytes.

1-2. The title of the project:

1-3. Name of the Principal Investigator (PI):

The “principal investigator” is the individual who will, in most cases, be the point of contact for the IRB. The PI must be a faculty, staff, or student at the University of Richmond. Only faculty and staff can serve as PIs on projects that are determined to be greater than minimal risk to participants.

1-4. PI email, phone number, and department/school affiliation:

1-5. Date of CITI online training in research ethics course completed by PI. (The course for faculty /staff is titled “UR faculty and staff researchers;” the course for students is “UR students conducting no more than minimal risk research.")

All University of Richmond investigators doing research with human subjects must complete a short program of online training provided by the Collaborative Institutional Training Initiative (CITI). Final approval will not be provided until that training is completed. For information on the training and how to register for it, check the IRB website section Researcher Training Requirements. Students should be careful to complete the course in CITI titled "UR students conducting no more than minimal risk research" and faculty and staff should complete the course titled "UR faculty and staff researchers). Only these course meet the requirement for researchers working with human participants.

1-6. For student projects, please identify a Faculty Advisor/Supervisor and the name of the course (if any):

Students should submit their materials to their supervising professor prior to sending them to the IRB for feedback, revision, and review. The IRB office, upon receipt of the IRB Review Form, will notify them that their student has submitted a project. Advisors are required to have completed complete a short program of online training provided by the Collaborative Institutional Training Initiative (CITI).

1-7. If other researchers are working on this project, provide their names, emails, and CITI completion dates (add table rows if necessary); provide contact information for any engaged collaborators at locations other than the University of Richmond.

All individuals who are “engaged” in the research project should be listed, where engagement means they are involved in interacting with subjects, consenting subjects, or analyzing identifiable subject information. If individuals on the project are not faculty, staff, or students at UR, but are nonetheless engaged in the research project, they should be listed, and it will be necessary to certify that they have completed training in the protection of human subjects.

1-8. Qualifications: Please describe your level of experience and/or training in the conduct of human research.

Advanced researchers need only note their general training background; students and novice investigators should provide information about their class-based experiences with research, or their work in research laboratories.

1-9. Conflicts of Interest: Do you declare any conflict of interest regarding this research?

Click Yes or No: A conflict of interest (COI) occurs whenever a researcher may have a personal or financial interest in the results of the study which could compromise their objectivity. If a conflict is possible, investigators will be asked to complete an online course in COI.

Section Two: Research Procedures

The section of the Review Form asks you to provide the details of the study you will be conducting.

2.1. Synopsis: Describe the scientific purposes of the project, including study aims and hypotheses to be tested. (For most projects, a 200 word or less summary is sufficient; use additional space for more complex projects.)

An understanding of the overall aim of the project and significance of the work is needed to determine the work’s scientific merit. This section should be well-developed in studies that involve risk, since risk is acceptable only when offset by significant scientific gains, applied knowledge, and so on. Review of protocols is facilitated when reviewers are informed about the context of the work. If previous work is cited, references for those citations should be included.

2.2. Summary of Research Procedures: Describe the research methods that will be used, including research design, type of measures, procedures, and locations. (For most projects, a 200 word or less summary is sufficient; use additional space for more complex projects.)

The description of the research methods will depend on the type of study being conducted. Self-report studies, such as surveys and interviews, will require description of the types of questions asked and how the survey will be administered. If individuals will be recorded in some what, that process should be described clearly. Observational studies required details regarding locations and issue related to privacy, whereas ethnographic studies additional details about the location, your role in the organization, and whatever aspects of the situation and participants’ interactions will you be recording in your field notes

2.3. Participants: Describe the study participants, including approximate anticipated number of subjects, their age, and any specific characteristics. Note if they are members of any identified vulnerable population, any factors that may affect the ethical acceptability or conduct of this research for this population, and describe steps taken to minimize the possibility of coercion or undue influence.

Indicate if the study involves adults only, if any classes of individuals are systematically excluded, or if the study is recruiting individuals from specific groups, such as prisoners, minors, undocumented individuals, institutionalized persons, wards of the state, elderly individuals (particularly if recruited from group homes), students contacted in their educational settings, employees, military personnel, cognitive impaired individuals, and so on. In general, if any subjects are under the age of 18, parental consent and subject assent will be required.

2.4. Recruitment: Describe how you will recruit subjects. Will you use word of mouth, Spider Bytes, emails, posters, etc.? Copies of recruiting materials must be submitted with the project.

If the methods of recruitment are complex, provide that information in a separate document. The exact wording of emails sent to students, recruitment messages given in classes, postings in online subject sites such as Mechanical Turk, are required.

2.5. Dissemination Plans: Describe how the findings will be disseminated, such as presented to external audiences (e.g., presentations in symposia), submitted for publication, posted on the Internet.

Section Three: Participant Protections

This section of the Review Form asks you to identify any possible risks the study poses for participants, and the procedures you have put in place to miminize those risks.

3.1. Direct benefits: Describe the benefits of the proposed research for those who take part in the research. (Indicate if there are “no direct benefits”; if compensation is provided, describe that compensation amount and process in detail.)

Benefits are of two types: direct benefits to participants (section 3.1) and more general benefits, such as the contribution of the work to science or society (section 3.2). Benefits listed in this section should be included in the informed consent statement, but general benefits (noted in section 3.2, below) are not cited in the consent form. If subjects are compensated, with course credit or monetarily, that amount of credit or money paid should be stated.

Often there are “no direct benefits” to subjects, other than the possible satisfaction of helping a student complete a research assignment. Do not overstate the benefits of the research.

If the project uses a third-party survey platform (e.g., Amazon’s Mechanical Turk) all subjects must be compensated at the specified rate, even if they terminate their participation without completing the survey and if they fail any “attention checks” built into the survey.

3.2. General benefits: Describe the general benefits of the research, other than the direct benefits to participants listed above.

3.3. Identification of Risks and Steps Taken to Minimize Risk: Describe any possible risks to participants in this study, including physical, psychological, or emotional harm, and steps taken to minimize those risks (Note: any risks noted here must be included in the consent form for this study).

Use this section to detail the risks of the research AND the steps taken to minimize any risks. A “minimal risk” might include the possibility that someone could be upset by a controversial topic or personal question. If such minimal risks exist, you should include them in this section and later list those same risks in the consent form. All research studies involve some risk, so do not state that they study has no risks at all. The accepted phrases include “The study poses minimal risk for participants” or “The risks for study participants are minimal.”

3.4. Risk level: Indicate if, in your judgment, the study’s risks are greater than minimal, where “Minimal risk means that 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” (Code of Federal Regulations, 45 CFR 46.)

Click Yes or No: Investigators are asked to estimate the level of risk in the study, but the IRB will make its own determination of risk. If the IRB considers the study to great than minimal, it will require that either a UR faculty or staff member serve as the PI.

3.5. Privacy Protections: Describe precautions that will be used to ensure subject privacy is protected.

Note that “anonymity” means that not even the researcher is able to determine the identity of a subject. Interviews cannot be anonymous but the researcher can provide confidentiality. Detail how anonymity or confidentiality will be provided and privacy protected.

3.6. Data Safety: Describe precautions that will be used to maintain the confidentiality of identifiable information.

Data protection is particularly critical if individual participants can be associated with their responses. Please describe steps take to maintain data safety and monitoring. Also, note that approval of the study by the IRB pertains only to the requirements of 45 CFR 46 regulating research with human participants, and therefore does not address other local, state, federal, or international requirements or restrictions, such as regulations pertaining to the use of data (e.g., the guidelines set forth by the Family Educational Rights and Privacy Act and the Health Insurance Portability and Accountability Act of 1996) and Title IX of the Civil Rights Act of 1964.

3.7. Additional Requirements: Indicate any features of the research requiring additional regulatory review below:

-- This project is funded by a federal agency or will be submitted for funding

-- Participants are an identified vulnerable population (e.g., less than 18 years of age, employees, prisoners)

-- This project requests a waiver of an element of consent or documentation of consent

-- This project includes international sites (international research form required)

-- This project is a multisite study (multisite study form required)

-- This project requires an authorization agreement with one or more external agencies or institutions (provide information about those external contacts)

-- The project qualifies as a clinical trial and so must be registered on ClinicalTrials.gov

Some research projects require additional review, as noted here. Many federal agencies have special standards of review for grant projects, including completion of training in scientific integrity. Multisite studies must name a single IRB as the IRB of record, and investigators must describe the methods they will use to coordinate activities across the sites. Some projects require review by multiple IRBs. These unique features of research should be noted here and discussed by email with the IRB office.

Section Four: Consent

Gaining the consent of participants is essential to the ethical conduct of research. The regulations about consent are very details, requiring consent forms contain several identifiable elements. This section asks you to indicate that you have included each required element in your consent form.

4.1. Elements of Consent: The consent document for the research should be submitted along this Form for review. Verify, using the checklist below, that the consent form includes each identified element of consent, or provide a justification for the absence of any required elements of consent.

Examples of wording for consent forms are listed here, and can also be accessed at IRB.richmond.edu. Some language can be directly copied and pasted into the consent form, but other sections of the form should be edited to fit the specific study.

The consent form includes all the following required elements (check all that apply):

-- A statement that the study involves research

Example: You are being asked to take part in a research study of [some topic]. Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study.

-- An explanation of the purposes of the research and the expected duration of the subject’s participation

Example: The purpose of this study is to learn more about [purpose of the work]. The study should take approximately [state time] to complete.

-- A description, in language understandable by a layperson, what the subjects will do as participants in the study (e.g., reports of personal information or experiences, complete of self-assessments, making judgments, solving memory problems, reporting their opinions), including identification of any procedures that are novel or untested

Example: If you choose to participate, you will be asked to answer questions related to your [opinions, self-perceptions, judgments]. You will also be asked to complete several questionnaires that measure these aspects of your [personality, political orientation, etc.], including…

-- Contact information for the investigator(s)

Example: This research is being conducted by [Name]. If you have any questions about the project, [Name] can be contacted at [indicate contact information].

-- A description of any reasonably foreseeable risks or discomforts to the subject

Example: There is no more than minimal risk involved in participating in this study. That is, the risks for completing this study are no more than the risks experienced in daily life. You may find some questions offensive, and you may be uncomfortable or stressed in answering them. If you do experience any discomfort during the study, please feel free to skip specific questions or withdraw without penalty.

-- A description of any benefits to the subject that may reasonably be expected from the research

Example: We will you for your time by taking part in this study. All who participate (approximately 100 people) will receive a $1 in payment, and 5 individuals will be selected, at random, to receive gift cards from Amazon.com of $25 each.

-- A description of the use of information and data collected

Example: We will not tell anyone the answers you give us. Your responses will not be associated with you by name and the data you provide will be kept secure. What we find from this study may be presented at meetings or published in papers, but your name will not ever be used in these presentations or papers.

-- A description of how confidentiality of records identifying the subject will be maintained; participants should be told if identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies

Example: The questions do not require that you disclose any identifying information, and your responses will be treated confidentially. However, as with any research process, the risk of a breach of confidentiality is always possible. Nevertheless, to the best of the investigators’ abilities, your answers in this study will remain anonymous and confidential. Once the study is completed, we will completely “deidentify” our data. All identifiers will be removed from the identifiable private information or identifiable biospecimens and only then will the the information be used for future research studies.

-- An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject

Example: If you have any questions concerning your rights as a research subject, you may contact the Chair of the University of Richmond’s Institutional Review Board for the Protection of Research Participants, at 804-484-1565 or at irb@richmond.edu.

-- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled to.

Example: The study has been described to me and I understand that my participation is voluntary and that I may discontinue my participation at any time without penalty. I understand that my responses will be treated confidentially and used only as described in this consent form. I understand that if I have any questions, I can pose them to the Principal Investigator.

-- A means to indicate understanding and acceptance of the conditions of consent

Example: By signing below I attest that I am over 18 years of age and that I consent to participate in this study. (Provide space for dated signature of participant and signature of the witnessing researcher.) NOTE: For online surveys, (in lieu of a signature), the consent can be obtained by including language such as the following. “I have read and understand the above information and by clicking on ‘Submit’ and taking this online survey I am providing my consent to participate and I attest that I am over 18 years of age.”

4.2. Justification. Please provide a justification for any waiver of the requirement for an element of consent below.

In some cases the IRB will agree to waive the requirements for some or all elements of consent. Specifically, when subjects are not fully informed of the purposes of the work in advance of their participants, investigators can request a waiver of that element if the work meets the four conditions for that waiver specified in §46.116:

(1) The research involves no more than minimal risk to the subjects;

(2) The waiver of the signed consent will not adversely affect the rights and welfare of the subjects

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In such cases the IRB will require you provide subjects with a written statement regarding the research, in their preferred language, if they request such a document.

4.3. Additional elements. Indicate, if required, other elements included in the consent:

-- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained

-- For treatment studies only: A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

Section Five: Affirmation Section

Please check the following indicating your acceptance of these statements.

-- To my knowledge, the answers in this form are accurate.

-- For students: My Faculty Advisor/Mentor will review and approve this study’s protocol prior to submission to URIRB.

-- I will read and abide by all of the Notices of Actions and Conditions of Approval from the IRB that I receive.

-- If one or more of the Board’s requirements are not acceptable, I understand that I may ask the Board to reconsider its requirements, but may not enroll subjects until the issue is resolved in a manner acceptable to the Board.

When completed, submit this form, as well as other required documents (e.g., consent form, survey items), directly to the IRB at IRB@richmond.edu. Contact the IRB if you do not receive confirmation of the receipt of your submission within 3 business days.