1. Initiating the IRB Review Process
2. After Submission: The Review Process
5. Reporting Complaints or Unanticipated Problems
6. Changes in Protocols
7. Expiration Date/Continuing Reviews
8. End of Project Reports
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 (firstname.lastname@example.org).
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.
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.
Levels of Review
1. Exempt: Research may be Exempt from IRB review because it either makes use of existing records, involves standard educational/psychological tests, 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, the IRB Chairs 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 examples likely considered to be Exempt from review.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, where information is recorded anonymously (i.e., so that the human subject cannot be identified, directly or indirectly through identifiers linked to the subject). All survey/interview/observational research in which elected or appointed public officials or candidates for public office serve as subjects is Exempt, whether or not data collection is anonymous. Such research is Exempt unless any disclosure of the human subjects' responses outside the research could place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available or the information must be recorded anonymously (i.e., in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject).
- Research on instructional strategies conducted in educational settings, involving normal educational practices (such as research on regular and special education strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods).
2. 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 two members of the Board will review the proposal and advise the principal investigator of the outcome.
Activities approved in the federal regulations for Expedited review include:
- collection of biological specimens through noninvasive means; for example, electrocardiography, electroencephalography, thermography, Doppler blood flow, echocardiography, functional magnetic resonance imaging;
- clinically routine noninvasive procedures such as muscular strength testing, moderate exercise, body composition assessment, flexibility testing involving healthy subjects;
- research on individual or group characteristics or behavior (including but not limited
to research involving perception, cognition, surveys, interviews, and focus groups)
- involving adults, where (i) the research does not involve stress to subjects, and (ii) identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation;
- involving children, where (i) the research involves neither stress to subjects nor sensitive information about themselves, or their family; (ii) parent/guardians will complete the usual consent form (i.e. there is no request for a waiver); (iii) identification of the subjects and/or their responses would not reasonably place them or their family members at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of themselves of their family members;
- collection of data from voice, video, digital or image recordings, as long as identification of the subjects and/or their responses does not place them at risk for criminal or civil liability, or damage their financial standing, employability or reputation;
- research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens), where these materials have been collected prior to the research for a purpose other than the proposed research, and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio or videotapes, names will be recorded, even if they are not directly associated with the data).
3. 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 likely to require Full Review:
- The proposed research involves active or passive deception.
- The researcher asks for a waiver of written Informed Consent.
- The proposed research involves vulnerable populations (there may be instances of research with children that do not require full review; refer to Expedited category above).
- 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 procedures of the research involve more than minimal risk to the subject (where more than minimal risk means that the probability and magnitude of harm or discomfort anticipated in the proposed research is greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).
- The proposed research involves observation where the individual could reasonably expect privacy (i.e. in the individual's home).
- The proposed research requires links between the individual and his/her behavior (e.g. a longitudinal study).
- 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.
- The proposed research involves physically invasive procedures (e.g. blood drawing or other tissue collection).
Criteria in Evaluating IRB 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?
There are three possible outcomes to a 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, because of the level of risk involved, cannot be initiated.
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.
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.
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.
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.
The Principal Investigator must complete the End of Project form within one year of the initial approval of the research project. Failure to complete this form will result in a request to cease research. Refer to the policy on non-compliance for more information.
- IRB Overview
- Review Process
- Categories of Review
- Consent Overview
- Informed Consent
- Minor Assent & Parental Permission
- Tips on Obtaining Consent
- International Research
- Guidelines for Internet Research