Institutional Review Board

Welcome to the JWU Institutional Review Board (IRB) Web page.

In accordance with its mission, guiding principles and strategic plan, Johnson & Wales University (JWU) encourages members of its community to engage in scholarship appropriate to their disciplines and individual aspirations. Such activity may not only lead individuals to fulfill their educational, intellectual and professional goals and enhance their discipline-specific and pedagogical authority, but also advance the university’s reputation and status as a teaching and learning institution overall by positively influencing related fields of study, contributing to the advancement of various commercial sectors and bolstering public trust in the institution and its leadership.

JWU strives to support scholars’ commitment to maintaining high standards of integrity and intellectual excellence. Research is one of several types of scholarship that members of the JWU community might pursue, and its federally registered institutional review board (IRB) was created to provide such support for research endeavors undertaken under its aegis.

The faculty members and external parties comprising JWU’s IRB are responsible for monitoring research activities before and during implementation to ensure their alignment with applicable policies, procedures, regulations and standards.

This page details the policies and procedures that are to be followed by members of the JWU community, inclusive of faculty, staff and students, who wish to engage in inquiry or research that involves human subjects and/or is intended to be shared with audiences external to JWU. Individuals who are external to the institution who wish to access members the JWU community for purposes of scholarly inquiry must also follow the policies and procedures established by the IRB.

IRB Chair: David Hood, Ph.D.
Associate Professor, College of Business
Email: institutionalreviewboard@jwu.edu


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Frequently Asked Questions

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.” (See https://about.citiprogram.org/en/mission-and-history/.) JWU requires principal investigators (PIs) 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. Please contact email institutionalreviewboard@jwu.edu for more information.

Must all PI’s undergo CITI training? Yes.

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.

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 The Faculty Writing Lab offers support to researchers at all phases of the research and writing process, from formulating a research question to proofreading a polished draft.

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.

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 an Unexpected Event Report Form. This form can be accessed through the IRB website.

What if something happens during the course of my research study that is not an unanticipated adverse event but results in changes to or causes problems with my research protocol? Depending on the nature of the problem, an Unexpected Event Report Form (UERF) may need to be submitted. Should the problem result in a change in the research protocol, an Amendment Form should be submitted. Should it turn out that more the study is going to take more time than was IRB-approved, an Amendment Form must be submitted. These forms can be accessed through the IRB website.

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).

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IRB Meeting Schedule
Academic Year -- 2018/2019
Friday, October 19, 2018 – 10:00 AM to 12:00 PM
Friday, November 9, 2018 – 1:00 PM to 3:00 PM
Friday, December 7, 2018 -- 1:00 PM to 3:00 PM
Friday, January 18, 2019 -- 10:00 AM to 12:00 PM
Friday, February 15, 2019 -- 10:00 AM to 12:00 PM
Friday, March 22, 2019 -- 10:00 AM to 12:00 PM
Friday, April 26, 2019 -- 1:00 PM to 3:00 PM
Thursday, May 23, 2019 -- 10:00 AM to 12:00 PM
Thursday, June 27 2019 -- 10:00 AM to 12:00 PM
July 2019 Meeting – TBD
August 2019 Meeting – TBD
IRB Meetings will be cancelled if there are no proposals to review.
Schedule for IRB meetings July 2019 – June 2019 will be published by April 30, 2019.
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IRB Process Overview

This document provides an overview of operational procedures of JWU’s IRB and is intended to provide guidance for navigating the institutional review of research process at JWU.

Questions about this process should be emailed to the IRB Chair at institutionalreviewboard@jwu.edu.

A. Submission and Preliminary Review of Research Proposal Application (RPA):

  1. The followings steps must be completed by the Principal Investigator (PI) prior to completing an RPA:

    a. Access resources available through JWU’s IRB web page
    b. Review Frequently Asked Questions (FAQ) document on JWU’s IRB web page.
    c. Complete the basic training modules through Collaborative Institutional Training Initiative (CITI) modules (see IRB webpage for more information.)

  2. The PI will complete the RPA and submit it through JWU’s IRB web page.

  3. A staff member in the Office of the University Provost (the Provost’s Office) will conduct a preliminary review of each application to ensure it is complete. Incomplete applications will be returned to PIs for revision. Applications determined to be complete will be assigned an official record number, entered into the log maintained by the Provost’s Office and forwarded to the IRB chair.

  4. An RPA must be received a minimum of 15 working days in advanced of a scheduled IRB meeting to be considered for placement on the agenda.

B. Initial Review of Applications and Category Assignment by IRB Chair:

  1. The IRB chair will review the completed applications for quality before assigning the application to one of the following categories listed below. Once assigned a category, the PI will be notified of the category designation. The IRB chair or designee reserves the right to request clarification of any application prior to making category assignment.

    a. Exempt: 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

    In general, projects are not considered exempt if they include any planned degree of deception, involve sensitive information, involve more than very minimal risk to participants, or include protected classes or vulnerable populations.

    b. 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.

    c. Full Board 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.

  2. Once assigned to a category, the application review process will proceed as described below.

 C. Procedure for Reviewing Exempt Applications

  1. The IRB chair or designee will determine whether or not a research protocol is exempt from expedited or full review. Although the protocol may be exempt from review as defined in this document, the chair or designee will review the protocol for compliance with university policies and procedures or overall quality.

  2. Following review, the PI will receive official notification from the IRB chair concerning the result of the review: Approved, Modifications required or Declined*. This information will be entered in the official log maintained by the Provost’s Office.

 D. Procedure for Reviewing Expedited Applications

  1. Applications containing research protocols suitable for expedited review will normally be reviewed by the IRB chair; however, at the chair’s discretion, such reviews may be assigned to another member of the IRB (voting or non-voting) to conduct outside of the monthly IRB meeting.

  2. Following review, the PI will receive official notification from the IRB Chair concerning the result of the review: Approved, Modifications required or Declined*. This information will be entered in the official log maintained by the Provost’s Office.

    (*The reviewer may decline a proposal for reasons related to compliance with JWU’s policies and procedures or its overall quality. If the reviewer recommends that the application be “Declined” for reasons related to protection of human subjects or for other reasons, he or she will submit the application to the IRB for full review according to the IRB’s regular procedures.)

 E. Procedure for Applications Requiring Full Review

  1. Applications containing research protocols requiring full review by the IRB will be assigned a lead reviewer, who will lead the IRB’s discussion.

  2. All IRB members will review all applications requiring full review and prepare to participate in IRB meeting discussions.

  3. Upon establishment of a quorum, the IRB will vote on the proposal. All actions taken during an IRB meeting are considered binding.

  4. 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. This information will be entered in the official log and record maintained by the Provost’s Office.

F. Official IRB Actions Following Proposal Review

The review of an Research Proposal Application (RPA) will result in one of the following actions, communicated by the IRB chair to the PI:

  • Approved indicates that there are no concerns with the study proposed in the application, and the PI may commence the planned inquiry.
  • Modification required indicates that there are issues with the proposed inquiry that must be resolved before approval can be granted. Specifics of the required modification and process for resubmission will be communicated by the IRB chair.
  • Declined indicates that the proposal is not approved. All decisions of the IRB are final.

 G. Monthly Meetings of the IRB

By April 30 of each calendar year, the IRB chair will establish the following academic year’s schedule of monthly meetings. The list of meeting dates will be published on JWU’s IRB web page and posted on the IRB ulearn Organization web page.  If there are no proposals requiring full board review, the IRB chair may opt to cancel a meeting, provided there is no pending IRB business requiring action.

H. Special Meetings of the IRB

  1. Special meetings may be convened at the discretion of the IRB chair as needed to support institutional initiatives and ensure efficient conduct of IRB business.

  2. The agenda of a special meeting will be limited to items requiring immediate action and will conclude once items have been disposed of. Official actions of the IRB will be recorded through the meeting minutes and will be entered in the official log and record maintained by the Provost’s Office.

  3. Notification of IRB decisions will communicated by the IRB chair within five business days, following the procedure prescribed for monthly IRB meetings, unless special circumstances dictate a faster notification timeline.

I. Amendment Request

  1. Request for protocol modifications and study extensions will be screened by the IRB chair to determine the extent of the proposed changes.

  2. If the proposed changes are not significant (e.g. would not involve change in PI, overall scope of work, funding source, etc.) the review will be conducted by the IRB chair. Following review, the PI will receive official notification from the IRB Chair concerning the result of the review: Approved, Modifications required or Declined. This information will be entered in the official log maintained by the Provost’s Office.

  3. Requests for significant changes to the previously approved study will be assigned and reviewed according to the criteria and procedures described in this document for new IRB applications.

J. Unexpected Event Reporting

  1. It is the PI’s responsibility to complete and submit the Unexpected Event Reporting Form (UERF) to the IRB chair through JWU’s IRB web page when unanticipated events are discovered during the course of the research no later than five business days after an occurrence.

  2. When a UERF is received, the IRB chair will immediately notify the ex-officio member representing the Provost’s Office who will work with the IRB chair to determine the need to notify other university stakeholders such as Office of the General Council, Equity & Compliance Services, Risk Management, Information Technology, Human Resources, Safety & Security and/or the IRB.

  3. A meeting with appropriate stakeholders will be convened by the IRB chair. The results of the meeting, including required action steps, will be communicated to the PI in writing within 24 hours. This information will also be entered in the official log and record maintained by the Provost’s Office.

K. Inventory of IRB Forms

The following forms and reporting requirements support and document the work of the IRB:

  • Research Project Application (RPA)
  • Amendment Form
  • Unexpected Event Form (UERF)
  • Closure Form

L.  IRB Terms and Definitions

Terms and definitions used by the JWU IRB can be found on the Definitions of Terms page.

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Definitions of Terms

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; or 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.

 

Forms