Institutional Review Board

• Research Proposal Application (RPA)
• Faculty Advisor Authorization 
• Request to Survey JWU Populations via Email
• Request to Recruit JWU Populations via Email
• Consent Form Template: This Consent to Participate in a Research Study form (.docx format) is a template that you may use to create a consent form for your research study.
• Amendment Form
• Continuing Review Form
• Reportable Occurrence Form
• Closure Form

What is an IRB and what is scope of responsibility of JWU’s IRB? An IRB is a group of faculty members and external parties who are responsible for considering all intended human-subjects research and, when deemed necessary, examining, critiquing, approving (or disapproving) and monitoring research activities before and during implementation to ensure their alignment with applicable policies, procedures, regulations and standards.

At JWU, the IRB will be responsible for the review of all research proposals connected to the university that involve human subjects and/or all research that is intended to be disseminated to external audiences. Members of the JWU community who plan to conduct studies, as well as individuals who are external to the institution who wish to access members of the JWU community for purposes of scholarly inquiry, must seek approval prior to commencing a study involving human subjects or whenever the results of a study will be shared externally. This approach allows JWU’s IRB to ensure that research activities connected to the university are aligned with applicable policies, procedures, regulations and standards and will allow more accurate assessment of the nature and scope of research activities taking place across the university’s campuses.

What if I’m not conducting research involving human subjects? Must I still submit a Research Application Form to the IRB? If research is being conducted with the intent to disseminate it, then yes, a Research Application Form must be submitted to the IRB.

Do I need IRB approval before submitting a grant application? The answer depends on the requirements of the grant and its sponsor. In some cases, full or pending IRB approval will be required prior to proposal submission. In other cases, sponsors will accept a proposal and notify the applicant that he or she should seek IRB review and approval because funding is likely. This is called the “just-in-time” approach.

What do I need to do to submit an application for IRB review? Directions and requirements for submitting a Research Project Application (RPA) to the IRB are available on JWU’s IRB webpage. A complete RPA includes completion of an online form and submission of supporting documents such as consent forms, interview protocol, certificate showing completion of CITI training, etc.

What is CITI Program training? The Collaborative Institutional Training Initiative (CITI Program) provides “high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics.” JWU requires principal investigators (PIs), co-principal investigators (co-PIs), and all others involved in research, as defined below, to complete CITI Program training so that they are prepared to conduct their activities according to the highest ethical standards and promote a culture of trust and accountability. Contact email institutionalreviewboard@jwu.edu for more information.

Must all PIs (including co-PIs) undergo CITI training? Yes.

I hold a current certificate of responsible conduct of research training. Do I also need to complete CITI training or will the IRB accept my alternative certification? You may submit documentation of your alternative certification to the IRB chair for consideration. If accepted, the requirement of completing CITI training may be waived.

Must I still complete CITI training if my research does not involve human subjects? Yes.

What should I expect after I submit my RPA? A staff member in the Office of the University Provost (the Provost’s Office) will conduct a preliminary review of your application to ensure it is complete. Should your application be deemed incomplete, it will be returned to you for revision. Completed applications will be assigned an official record number, entered into the IRB application log maintained by the Provost’s Office and forwarded to the IRB chair, who will assign the RPA to one of three review categories: Exempt, Expedited or Full-Review.

IRBs are associated with terms like Exempt, Expedited, and Full-Review. Why does the IRB not classify reviews in the same way? The IRB does not classify all reviews in the same way because research protocols differ in the extent to which human subjects are involved. For example, one researcher may submit a proposal requesting approval to study the results of the Graduation Writing Requirement — essays, essentially — while another researcher may submit a proposal to study how cancer patients respond to plant-based diets. The second study involves human subjects in a much more extensive manner; therefore it needs to be reviewed much more extensively.

How long does the review take? A Research Project Application (RPA) must be received a minimum of 15 working days in advance of a scheduled IRB meeting to be considered for placement on the agenda. Within five business days after the IRB review, the PI will receive official notification from the IRB chair concerning the result of the review: Approved, Modifications required or Declined.

What if my project changes after I’ve received IRB approval? If anything in your approved research protocol changes — the number of participants, a new co-PI, the departure of a co-PI, the number of survey questions asked, etc. — you must submit an Amendment Form.

What if my research is done in my own classroom? If classroom research is not disseminated, then the researcher does not need IRB approval. IRB approval is required for any formal research with the intention to disseminate it.

I am a faculty member. May I offer students extra credit to participate in my research study? Faculty may not offer extra credit for participation in research studies.

Is it permissible for JWU employees and students to collaborate on research as co-PIs? JWU faculty members and administrators may collaborate with students on research projects as co-PIs provided that those faculty members and administrators are not serving on the students’ dissertation committees or otherwise in a position to evaluate the students’ work or influence such evaluations.

May I offer a prize or otherwise reward individuals for participating in my study? JWU does not permit researchers to reward study participants through games of chance such as prize drawings, raffles, lotteries, etc. However, researchers may provide reasonable compensation for participation in a study. The form of this compensation must be specified in the RPA submitted to the IRB.

Do I still need IRB approval if my research is done off-campus? If the research off campus is being conducted with the intent to disseminate it, then yes, a Research Project Application must be submitted to the IRB.

What if I don’t want others to know about my research until I’m ready to disseminate it? All research projects are confidential. Your research will not be discussed outside the confines of the IRB.

What if I’m new to research? There are many resources available to support you as you embark on research. The Faculty Center for Academic Excellence & Innovation offers workshops on research and offers support to researchers at all phases of the research and writing process.

How do I submit the Research Project Application (RPA)? RPAs, along with required supporting documents, should be completed by the principal investigator and submitted through the JWU IRB website.

Is there a consent form template I can use? Yes. There is a sample consent form template available through the IRB webpage.

Can I use a third-party transcription service? Yes, however the third-party transcription service must ensure confidentiality.

For how long is IRB approval valid? IRB approval for all studies is valid for 12 months from the date provided on the official approval memo sent by the IRB chair. A PI can request an extension beyond the assumed 12-month expiration either in their RPA or during an ongoing study. To request an extension for an ongoing study, the PI is required to submit an Amendment Form (found in the “Forms” section of this page). Note that all PIs are required to submit a Closure Form (see “Forms”) at the conclusion of their study.

What if my research takes longer than indicated in the RPA? If your research takes longer than indicated in the approved RPA, you must submit a JWU IRB Amendment Form. This form can be accessed through the IRB website.

What if something happens during my research study that I was not anticipating?Should an unexpected adverse event occur, you are required to submit a Reportable Occurrence Form (ROF), which can be found in the “Forms” section.

What if something happens during the course of my research study that is not an unanticipated adverse event but results in changes to my research protocol? Depending on the nature of the occurrence, a Reportable Occurrence Form (ROF) may need to be submitted. may need to be submitted. Should the occurrence result in a change in the research protocol, an Amendment Form should be submitted. Sresult in a change in the research protocol, an Amendment Form should be submitted. Should it turn out that the study will take more time than was IRB-approved, an Amendment Form must be submitted. (See the “Forms” section.)

What is required if I am conducting research involving animals? Research involving animals requires special considerations related to animal welfare. Please contact the IRB chair at institutionalreseachboard@jwu.edu to discuss specific CITI trainings that may be required and the possibility of external review by an Institutional Animal Care and Use Committee (IACUC).

Does the university allow research with minors? The IRB requires researchers to obtain assent from all subjects between the ages of 6 and 17 unless a clear justification of waiver or alteration of assent is provided and approved by the IRB.

What is assent? Assent refers to a scenario in which someone is unable to give legal consent to participate in research. 

My study involves children under the age of 18. In addition to obtaining parental consent, am I required to obtain assent? IRB policy requires researchers to obtain assent from all subjects between the ages of 6 and 17 unless a clear alteration of assent is provided and approved by the IRB chair, prior to submission of an RPA.

What are the requirements for underage assent?

Ages 0-5 Consult first with the IRB chair.

Ages 6-7 Give a simple verbal description of the research based on the scripted assent form. Document the procedure using that form. The form must be signed by a witness who is not the child’s parent or guardian.

Ages 8-13 Give the participant a more complete verbal description of the research based on the scripted assent form below. Document the procedure using that form. The form must be signed by a witness who is not the child’s parent or guardian.

Above age 13 Request written assent using age-appropriate documents.

As the PI, I am not going to be asking for assent and instead a co-pi (or equivalent) will facilitate the assent process. Does this impact my RPA? Should you have a research assistant that will be collecting assent on your behalf, you can request an alteration (through the IRB chair).

What if a child does not grant assent but the child’s parents grant consent? If the child dissents from participating in research, the child’s decision prevails even if his or her parents or guardian have granted consent. If a child is capable of assent, it must be obtained before the child can participate in the research activity.

However, the assent requirements may be waived in cases in which the research could potentially be a direct benefit to the health or well-being of the child and is available only in the context of research.

What about emancipated minors? The emancipated court order must be copied and included in the research records with the consent document if an emancipated minor provides consent for him or herself.

What should be covered in an assent form? The assent form, at a minimum, should include a description of the research project, information about what the subject is being asked to do, information about the possible risks and benefits and a statement that participation is entirely voluntary.

The assent form (see template) should be developed with a consideration for the children’s ages, developmental levels, literacy levels, and other factors. A single method may not be appropriate for all potential participants; several approaches may be necessary to ensure the participant understands the information being presented.

Who is a PI? The person who assumes complete responsibility for a research project is considered the principal investigator (PI). The PI is responsible for submitting a complete RPA to the IRB and supervising any and all co-principal investigators (Co-PIs) and/or research associates (e.g. research/teaching assistants and students) involved in the procedures and methods described in the RPA.

The IRB only allows for a single person to be listed as PI, regardless of the number of Co-PIs and/or research associates involved in the administration and execution of an approved RPA. For studies involving research associates, the RPA should include an attached document with their names and a rationale for their role in the study. No entity or organization can be listed as PI or Co-PI.

In the case of a doctoral dissertation, the student is the only person who can be listed as the PI. Unless the PI obtains written approval from their academic dean, dissertation advisors are prohibited from being included as Co-PIs or research associates in their advisee’s dissertation research. In other student-led human subject research, the student will be listed as PI unless written approval is granted by the student’s academic dean in advance of the submission of the RPA.

If JWU’s IRB is designated as the IRB of record (reviewing IRB) for a multi-site research project, the PI assumes responsibility for managing personnel and research activities in accordance with terms set forth in agreements with sponsor(s) or participating sites or both for all Co-PIs and research associates.

Can I use my JWU email account in my research? The IRB recognizes that email is often the preferred method of communication throughout a research study. This includes, but is not limited to, email regarding IRB communications, recruitment of study participants, requests for information, site approvals and/or grant documentation. Research involving human subjects conducted by a JWU community member may only be communicated using a secure university email account (any assigned email account ending with @jwu or @wildcats.jwu.edu). Should a study require the use of an alternate email server, written permission from the IRB chairperson must be requested and granted prior to the submission of the RPA.

No group or division email (e.g. internationalstudentservices@jwu.edu) may be used in any communication related to a human subject research study with the exception of the following circumstances:

• the PI has made a request, through the IRB, to email/recruit entire JWU populations, and/or
• written permission from the IRB chairperson was requested and granted prior to the submission of the RPA.

See the IRB FAQ’s for more information regarding how to request authorization to email/recruit JWU populations.

Adverse event

An adverse event is any untoward or unfavorable medical occurrence in a human subject. Such occurrences would include any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. NOTE: Generally, few adverse events fit the criteria for unanticipated problems (see below), which must be reported according to university policy and when applicable, research sponsors' requirements.

An adverse event is considered serious and must be reported to the IRB and, if applicable, to sponsors if it meets one of the following criteria:

1. Results in death
2. Is life-threatening (places the subject at immediate risk of death from the event as it occurred)
3. Results in inpatient hospitalization or prolongation of existing hospitalization
4. Results in a persistent or significant disability/incapacity
5. Results in a congenital anomaly/birth defect
6. Results in a sustained mental deterioration that is caused directly through psychological intervention/methods
7. Based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Belmont Report

The Belmont Report (full title: Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research) was issued in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its findings, cited and summarized by the U. S. Department of Health & Human Services (HHS), provide the ethical foundation for undertaking research involving human subjects. Its three core principles are respect for persons, beneficence and justice, and it emphasizes informed consent; assessment of risks and benefits; and selection of subjects.

Exempt research

Research involving activities that will pose minimal or no physical, economic or reputational risk to human subjects.

Exempt research projects will usually fall into at least one of the following categories:

• i. Research on normal educational practices that will take place in established or commonly accepted educational settings
• ii. Research that will only involve educational tests, surveys, interviews and/or observations of public behavior, and human subjects are not identifiable, or would not be at risk of harm if their identities were known
• iii. Research involving benign interventions, i.e. those that are brief in duration, harmless, painless, not physically invasive and unlikely to have a significant adverse impact or offend or embarrass the human subject(s), and in which human subjects are not identifiable or unlikely to be at risk of harm if their identities were known
• iv. Research that is secondary and for which consent is not required because data or specimens are publicly available, subjects’ identities are not readily ascertained, and the PI will neither contact nor re-identify subjects
• v. Research and demonstration projects that will be conducted or supported by a federal department or agency or otherwise subject to federal approval and that are designed to study public benefits or services
• vi. Research in which human subjects will only be involved for purposes of evaluation of taste and food quality and consumer acceptance
• vii. Research that will only involve the storage or maintenance of identifiable data or specimens, as long as the IRB has conducted a limited review to determine that privacy provisions are adequate
  
  viii. Research that will involve secondary analysis of existing private identifiable data and biospecimens provided that broad consent was obtained from, or consent was waived by, the subjects, and that consent was given limited IRB approval

Expedited review

Research involving activities will pose no more than minimal risk physical, economic or reputational risk to human subjects. Projects eligible for expedited review will usually fall into at least one of the following categories:

• i. Clinical studies of some drugs and medical devices
• ii. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture with some restrictions related to population and amounts to be collected
• iii. Prospective collection of biological specimens for research purposes by noninvasive means
• iv. Collection of data through noninvasive procedures that are routinely employed in clinical practice and that do not involve sedation, microwaves or x-rays
• v. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes
• vi. Collection of data from voice, video, digital, or image recordings made for research purposes
• vii. Research on individual or group characteristics or behavior or research employing surveys, interviews, oral histories, focus groups, program evaluations, human factors evaluations, or quality assurance methodologies. Expedited review may also be used when minor changes are made to a previously approved research project, as long as the project is within the originally approved investigation period.

Full review

Research that presents more than minimal risk for human subjects, or involves sensitive topics or vulnerable populations or is otherwise non-exempt or ineligible for expedited review.

Human subject

A human subject is a living individual about whom an investigator conducting research:

1. obtains information or biospecimens through intervention or interaction with the individual and uses, studies or analyzes the information or biospecimens; or
2. obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention

Interventions include both physical procedures by which data are gathered and manipulations of the subject or the subject's environment for research purposes.

Institutional Review Board (IRB)

Commonly referred to as “the IRB,” an Institutional Review Board is a committee comprising faculty, administrators and external experts charged with review of all research protocols conducted under the auspices of JWU when their results are intended for external dissemination. IRB members are primarily responsible for ensuring that research methods and activities are implemented in full alignment with laws, university policies, and standards for protection of human subjects and the university’s reputation and status.

Interaction

Interactions include communications or interpersonal contacts between investigators and subjects.

IRB Research Project Application (RPA)

An IRB RPA is an online form used to request approval for a study which includes the IRB application online form and supporting documents (CITI certificate, study protocol, consent form(s), survey, etc.)

Lead reviewer

The lead reviewer is a member of the IRB assigned by the chair to review and present one or more RPAs to the IRB.

Minimal risk

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.

Principal investigator (PI)

The Principal Investigator has primary responsibility for (1) the planning, execution and reporting of a research inquiry; (2) overseeing all legal, policy-driven and financial aspects of the project; (3) if applicable, ensuring compliance with sponsors’ expectations, requirements and restrictions; and (4) responding to requests from the IRB and university officials.

Private information

Private information, as defined by HHS, 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 personally identifiable information that 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).

Research

Research, as explained by JWU’s Policy on the Institutional Review of Research and the Institutional Review Board’s Purpose and Authority, is systematic experimentation, study and evaluation that contributes to generalizable knowledge. Generally not considered research are creative and journalistic activities; public health surveillance activities authorized by a public health authority; collection and analysis of information, biospecimens or records for criminal justice or investigative purposes; activities that support national security.

Sponsor

A sponsor is an organization, agency or individual that funds or otherwise supports a project and may, depending on the type of award, be involved in the design, scope or other elements of the research. The entity accepting the sponsorship (usually the PI's employer or host institution) will generally have considerable obligations related to reporting and regulatory compliance.

Unanticipated problem

Unanticipated problems include incidents, experiences or outcomes that meet all of the following criteria:

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
2. related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. suggested that the research places subjects or others at a greater risk of harm (including physical, psychological, legal, economic, or social harm) than was previously known or recognized. Unanticipated problems must be reported to the IRB and, if applicable, to sponsoring agencies.

Unexpected adverse event

Any adverse event occurring in one or more subjects participating in a research protocol, the nature, severity, or frequency of which is not consistent with either: 1. the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; or 2. the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event. See "unanticipated problems," above, for criteria that would determine whether or not an unexpected adverse event qualifies as an unanticipated problem and would require reporting.

Vulnerable populations

Certain populations are considered “vulnerable” due to their members’ possible lack of autonomy or capacity to make informed decisions regarding their own participation. For JWU's purposes, these populations include children, prisoners, pregnant women, fetuses, neonates and individuals participating in some AIDS-related studies. Other populations may also be vulnerable. These include educationally or economically or educationally disadvantaged individuals, individuals with impaired decision making abilities, individuals who are illiterate or have low fluency in the research study’s language, or students or employees of the institution(s) involved in the research. Researchers must take special care when considering how to engage, and obtain informed consent from, members of these populations.

CITI training is for JWU populations only.

CITI USAGE GUIDE (PDF)

Johnson & Wales University (JWU) employees and, as may be required by agreement or policy, agents, consultants, representatives, and other affiliated individuals will strive to safeguard the university’s financial, legal, and reputational standing and their own credibility and reputations, by promoting objectivity while engaged in research activities.

JWU’s Procedures for Identifying and Addressing Financial Conflict of Interest in Research (the “Procedures”), which are based on federal regulations published at 42 CFR Part 50, Subpart F, are intended to honor that commitment through the management of financial conflicts of interest (FCOIs) that may arise during research activities.

The complete policy, as well as the two-part Disclosure of Significant Financial Interests (SFI) form, can be read in full below:

FCOI IN RESEARCH POLICY (PDF)