Review Process | Webster University

Review Process


1. Initiating the IRB Review Process
2. After Submission:  The Review Process
3. Outcomes
4. Appeals
5. Reporting Complaints or Unanticipated Problems
6. Changes in Protocols
7. Expiration Date/Continuing Reviews
8. End of Project Reports


1. Initiating the IRB Review Process

Doing research that involves human subjects is a privilege, not a right.  The IRB will work with applicants to meet the federal requirements.

However, the IRB cannot approve projects submitted after the fact.  Review prior to contact with human subjects is necessary to insure compliance with federally defined criteria for ethical treatment of human subjects.

THUS RESEARCH DONE WITHOUT IRB APPROVAL MUST NOT BE USED IN ANY PUBLIC PRESENTATION OR PUBLICATION.

By teaching students about the ethical treatment of human subjects, working with them on the applications, and treating this matter as an opportunity for ethical reflection rather than an irksome requirement, faculty are helping to prepare students to understand obligations they may be expected to shoulder in the future and to be responsible members of an ethical community.

Application.  Faculty members, staff member, or students who are planning research projects involving human subjects are responsible for beginning the review process by submitting the Application for Use of Human Subjects form to the Webster University IRB (irb@webster.edu).

Researchers must submit a fully-developed research plan and accompanying documentation (e.g. a questionnaire or scripts when the subjects are to be interviewed; as well as the Informed Consent Form).  Among other things, the Informed Consent Form describes the potential risks and benefits to potential human subjects.  In the case where students are the researchers, the applications must be reviewed and submitted by faculty or staff serving as the Faculty Sponsor before they are processed by the IRB.

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2.  After Submission:  The Review Process

All submitted proposals are assigned by the IRB to one of three categories:  Exempt, Expedited, or Full.  The level of review can only be determined by the IRB.  Even if you believe your proposal is exempt, you must submit it so that the board has the opportunity to make this determination. Furthermore, to fully protect subjects the IRB must approve a project before investigators start work on it, even before they begin to recruit subjects, since recruitment strategies are part of the review.  This is reflected in the following flow chart.

irb-flowchart

 

1. Review Determination

Exempt:  Research may be Exempt from IRB review because it either makes use of normal education practices, anonymous surveys or benign behavior interventions where subjects would not be subject to additional risks, or for other reasons listed in the federal regulations. However, it is up to the IRB (not the researcher) to determine whether a project is Exempt. In the case of Exempt research, an IRB member will review the proposal and advise the principal investigator of the outcome. In general, procedures that are free of foreseeable risk to the subject are likely to be Exempt. Following are some federal categories of research considered to be Exempt.

  • Research involving normal educational settings or practices
  • Research utilizing tests, surveys, interviews or observations where subject identifiers are not recorded, or subject responses would not reasonably place subjects at risk
  • Benign behavioral interventions where subject identifiers are not recorded, or subject responses would not reasonably place subjects at risk
  • Secondary research where information is publicly available, or information is recorded in a way that subjects cannot be identified
  • Taste and food quality evaluation where the food is considered safe and no additives are consumed

Expedited:  Research that poses only minimal risk to participants can be handled as Expedited. "Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. In the case of Expedited research a members of the Board will review the proposal and advise the principal investigator of the outcome.

Key features of minimal risk research, as approved in the federal regulations for Expedited review, include:

  • Risks to subjects are minimized
  • Research procedures are consistent with sounds research design and do not unnecessarily expose subjects to risk
  • Procedures used have already been performed on subjects previously
  • Benefits outweigh the risks
  • Selection of subjects is equitable and vulnerable populations are not targeted
  • Informed consent is obtained from prospective subjects and appropriately documented or waived
  • Adequate provisions for data monitoring to ensure subject safety during the research
  • For secondary research, broad consent is obtained or waived for the storage, maintenance, and use of identifiable private information or biospecimens
  • For secondary research where a change is made for research purposes, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of the data
  • Research with vulnerable subjects have additional safeguards included to protect their rights and welfare

Full Board Review:  All research that is not exempt or expedited is given a Full Review. This means that the proposal is reviewed during a convened meeting of the IRB, during which discussion of the proposal occurs. A majority of the Board members, and specifically, the community member, must be present.

These are some of the situations more likely to require Full Review:

  • The participation of subjects in the research exposes them to greater than minimal risk
  • Biomedical protocols (medical research/clinical trials/experimental therapies) involving physically invasive procedures
  • Research with vulnerable populations. Vulnerable populations are those research participants who are likely to be vulnerable to coercion or undue influence or lack decision-making capacity, including children, prisoners, pregnant women, neonates, mentally disabled persons, or economically or educationally disadvantaged persons, and those who may be vulnerable because of a physical condition, severe illness or pain, psychological or emotional condition, status relationship with a member of the research team, cultural or political factors or other circumstances
  • Projects that involve deception of subjects
  • Projects that plan to use procedures that are personally intrusive, stressful or potentially traumatic (stress can be physical, psychological, social, financial, or legal).
  • The researcher asks for a waiver of written Informed Consent.
  • The proposed research involves topics of a sensitive nature (sexual behaviors, illegal behaviors, drug or alcohol use, sensitive demographic data, etc.). The key principle used to determine whether a project involves sensitive information is that it has the potential for provoking a negative emotional reaction from a subject.
  • The proposed research includes collection of data from voice, video, or image recordings where identification of the subjects and/or their responses could place them at risk for criminal or civil liability, or damage their financial standing, employability or reputation.

2.  Criteria in Evaluating IRB Proposals

The IRB will consider the following factors in reviewing research proposals:

  • The IRB will consider the following factors in reviewing research proposals:
  • Is the research methodology sound?
  • Have the risks to subjects been minimized?
  • Are the risks reasonable in relation to anticipated benefits?
  • Is the selection of subjects equitable (e.g., free from racial, gender or other types of bias)?
  • Can the Informed Consent be easily understood? Does it adequately reflect what the subject can expect?
  • Has the researcher indicated how the data will be protected (to assure the privacy of the research subjects)?
  • Are any of the participants vulnerable to coercion or undue influence?

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3. Outcomes

There are three possible outcomes to a review:

  • Exempt Determination: The application is determined to be exempt and not subject to further review.
  • Approved: No further action is required from the investigator prior to initiating the study.
  • Revise and Resubmit: Changes are required before the study may begin. Additional or revised information must be submitted to the IRB prior to approval.
  • Denied: The proposed research cannot be initiated because the Board has determined that the risks outweigh the benefits of the research.

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4. Appeals

In the event that an application is denied because the Institutional Review Board feels the risks outweigh the benefits of the research, and the investigator disagrees with the committee's disapproval decision, the researcher may initiate an appeal by submitting a letter presenting the researchers arguments for approval, and any other pertinent information in support of the appeal.

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5.  Reporting Complaints or Unanticipated Problems

If a research encounters unanticipated problems involving risks to subjects or complaints about the research, the researcher should immediately report these problems to the Chair of the IRB. These problems may result in possible suspension or termination of the research.

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6.  Changes in Protocols

Researchers who want to make significant changes in a previously approved protocol must obtain prior permission from the IRB by submitting a Change/Extension in Protocol form.  This includes changes in the (approved) consent form, sample composition, sample recruitment, or study procedures.

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7.  Expiration Date/Continuing Reviews

Approval of a human subject research proposal is good for one year.  (However, if research involves extreme risk to subjects, the IRB may review it more frequently or alternatively ask to be kept apprised of all research activity.)  In the event that the study continues longer than the initial approval period, the principal investigator is responsible for requesting an extension using a Change/Extension in Protocol from.  To request an extension the principal investigator is responsible for submitting a status report of the project to date including:

  • how many subjects have participated to date;
  • a summary of any changes to the research protocol (as previously approved by the IRB);
  • any other relevant information, especially information about risks associated with the research.

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8.  End of Project Reports

For research projects determined to be Exempt or Expedited, no End of Project form is required. For Full Board Review projects, the Principal Investigator must complete and submit the End of Project form at the completion of research.  Failure to complete this form will result in a request to cease research.  If the research is not completed within one year of beginning the project, the IRB will conduct continuing review of the research. Refer to the policy on non-compliance for more information.

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