Chapter 6 – Types of IRB Review

6.A. Exempt Review
6.B. Expedited Review
6.C. Full Review
6.D. Review of Ongoing Research
6.E. Renewal of IRB Approval
6.F. Modifications to Previously Approved Research
6.G. Collaborative Research
6.H. Certification of Research
6.I. Suspension or Termination of IRB Approval

IRB reviews may be conducted by the IRB Director, by another IRB member, or by the full IRB. The type of review will depend on the study. Researchers should become familiar with the types of IRB review to ensure that their applications are appropriately designed. The requirement for including an informed consent process applies when human subject interaction occurs during a research study, regardless of the type of review. Applications and research proposals undergo one of three types of reviews: (1) exempt, which includes theoretical and creative studies (2) expedited, or (3) full. The IRB may decline to consider a research study that was completed without IRB review and approval.

 

6.A. Exempt Review

All research projects eligible for exempt review must be submitted to the IRB for review and approval. Researchers must submit either the Exempt Research Study Checklist – Application or the IRB Notification for Theoretical & Creative Research Projects form along with summary of the proposed research, including data sources and data collection and analysis methods. Any studies that the IRB determines are not eligible for exempt review must undergo expedited or full IRB reviews as described in this chapter and Chapter 7.

The following examples are of studies that could be eligible for exempt review. Studies of the types discussed in Categories 1 through 4 are often used in social and behavioral research.

  1. Educational Practices. Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (a) research on regular or special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Educational Tests (1). Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior, unless (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research could reasonably place subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. [A survey returned without a subjects’ name or any other identifier (an anonymous survey) may be considered exempt.]
  3. Educational Tests (2). Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior that is not exempt under (2(b)) above if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  4. Existing Data or Records. Research involving the study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  5. Public Benefit or Service Programs. Research and demonstration projects designed to study, evaluate, or otherwise examine (a) public benefit or service programs; or (2) possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste and Food Quality. Evaluation and consumer acceptance studies conducted for the purpose of determining whether (a) wholesome foods without additives are consumed; or whether (b) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration (FDA), or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA).

Researchers must submit a summary of their research study and a Exempt Research Study Checklist – Application form or a IRB Notification for Theoretical-Creative Research form to the IRB. The IRB Director will notify the researcher via e-mail regarding whether the study is exempt from IRB review.

6.B. Expedited Review

An expedited review process is used for certain kinds of research that involve no more than minimal risk but do not qualify for exemption and for relatively minor changes to previously approved research. To qualify for expedited review, the study must fit one or more of the following criteria. Studies that may qualify for expedited review include:

  • Research involving materials (data, documents, records, specimens, voice, video, digital, or image recordings) that were previously collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
  • Collection of data from voice, video, digital, or image records made for research purposes.
  • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
  • Continuing review of research previously approved by the convened (full) IRB as follows: (a) Where the research (i) is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled, and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
  • Changes to studies previously approved by the IRB, provided that the proposed changes do not result in more than minimal risk. Modifications are submitted to the IRB on the Modifications Request form.

Other types of medical and clinical studies also eligible for expedited review include:

  1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risk associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing, and the medical device is being used in accordance with its cleared/approved labeling.
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period, and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period, and collection may not occur more frequently than 2 times per week.
  3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) Hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth, and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) Physical sensors applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging (MRI); (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

The expedited review process may not be used when identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Studies must include procedures consistent with sound research design. The IRB will consider only risks and benefits that may result from participation in the study—distinguished from risks and benefits subjects might encounter if not participating. Finally, the IRB will not consider possible long-range effects of applying knowledge gained in the research (e.g., possible effects of the research on public policy) as among those risks/ benefits that fall within its responsibility. (See “Criteria for Approval.”)

Researchers must submit the IRB Application and Research Proposal and the Expedited Review Checklist form to the IRB Director. An expedited review may be carried out by the IRB Chair or by one or more experienced reviewers designated by the Chair from among voting members of the IRB. The expedited review is not available for federally classified research involving human subjects. Federally classified research is restricted to individuals with United States government security clearances.

6.C. Full Review

Full IRB review is required for proposed research (or proposed changes to previously approved research) that might reasonably be regarded to pose some degree of risk (i.e., greater than minimal. (See “IRB Application Preparation and Submission.”) If the answer is yes to any one of the following five questions, the research requires full review.

  1. Has previous research (researcher’s own or others’ research) indicated that this study presents a possible risk?
  2. Could participation in the study put a subject at risk for legal or civil liability, disciplinary action by an employer, invasion of their privacy in regard to sensitive aspects of her/his behavior (e.g., illegal conduct, drug use, alcohol use, sexual behavior), or have other adverse consequences, including embarrassment or other emotional distress?
  3. Will subjects be given drugs or other substances?
  4. Will the research involve intrusive procedures (physical, psychological, cultural)?
  5. Will the research involve subjects who have life-threatening physical conditions?

6.D. Review of Ongoing Research

The IRB conducts systematic reviews of previously approved, ongoing research with human subjects. As a condition of approval, the IRB may require the researcher to provide progress reports and/or a concluding report. If the IRB requires a progress report, the approval letter will include a submission date and an outline of the information the researcher is required to provide. The IRB may also decide, subsequent to approval, to require a progress report and/or concluding report.

  • Progress Reports. Progress reports typically include a description of the project to date, the number of subjects recruited, the number of subjects who withdrew from the study, reasons for withdrawal, a description of any changes to the research design, a description of any significant new findings, a description of any unexpected or adverse events, and a copy of the informed consent form in current use.
  • Concluding Reports. Concluding reports provide a brief statement that all data have been collected, a summary of the project, and a description of how and where the researcher will communicate findings. It may include sections of the dissertation, thesis, culminating project, etc.

Researchers are responsible for submitting required progress and/or concluding reports on or before the date established by the IRB. If a researcher fails to do so, the IRB may suspend or terminate approval for the study. The IRB may also suspend or terminate approval if a progress or concluding report describes a study that is substantively different from what was approved by the IRB and/or unanticipated or adverse events were not reported to the IRB. (See “Modifications to Previously Approved Research” and “Suspension or Termination of IRB Approval.”)

6.E. Renewal (Extension) of IRB Approval

Twelve (12) months is the maximum length of time granted for initial IRB approval of a research study involving human subjects. IRB approval is intended to cover recruitment and data collection. If these phases are not completed within the approved twelve (12) months, obtaining a renewal of IRB approval is required. IRB approval may be renewed/ continued for an additional six (6) or twelve (12) months. Researchers are responsible for supplying information necessary for obtaining a renewal of IRB approval of their research studies.

The IRB uses full IRB review procedures unless the research meets the expedited review criteria for continuing review. To approve the research, the full IRB will determine whether all requirements for the initial approval continue to be met. (See “Criteria for Approval.”) Continued IRB approval for higher-risk studies may be limited to a maximum of six (6) months. If researchers do not obtain official IRB renewal, they are required to suspend their studies until they have received a renewal. If the IRB determines that a research study has continued beyond its approval ending date, the IRB will require the researcher to suspend the study until he/she has applied for and received and IRB renewal to continue. Studies continued beyond the original approval period, without IRB renewal, are unapproved studies. Researchers who do not obtain renewals but continue their studies will be in violation of UI&U and IRB ethical requirements.

An expedited review procedure may be used for the continuing review of research previously approved by the full IRB as follows:

  • The research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects; OR
  • No subjects have been enrolled and no additional risks have been identified; OR
  • The remaining research activities are limited to data analysis.

To avoid interruptions to a study, a researcher should provide information needed to obtain a renewal at least two months in advance of the need for continued IRB approval. In most cases, the IRB Director can approve continuation of previously approved research. Continued review by the full IRB is required for studies originally reviewed and approved by the full IRB that do not meet the expedited review criteria for continuing review. (See Continuing Review/ Renewal Request form.)

6.F. Modifications to Previously Approved Research

IRB approval is required for substantive changes in the research model, informed consent form(s), survey instrument(s), or nature of subjects. IRB approval of the research with the proposed changes will extend no more than twelve (12) months from the date the researcher proposes to implement the changes.

If a subject experiences an adverse or unexpected reaction or side effect, the researcher will be required to make changes to the study to avoid future, similar situations. When an adverse event occurs, proposed changes to avoid additional adverse events require full IRB review.

The request for approval of proposed changes to a previously approved study should include the following:

  • A completed Modification Request form that includes a description of any proposed changes to the protocol and/or to study documents
  • Copy (ies) of informed consent form(s) and other study documents even if they will not be changed
  • A progress report (Continuing Review/ Renewal Request form) that includes:
    • Number of subjects who have participated to date, whether they are active, completed, or pending, and the time frame for future participation
    • Any unexpected events, adverse reactions, or side effects. If none, state none.
    • Summary of the results to date

Submit the revised documents, the Modification Request Form, and the Continuing Review/ Renewal Request form to the faculty advisor, dissertation chair, or supervisor for review and signature before sending it to the IRB Director; it will not be accepted for consideration without these approvals.

6.G. Collaborative Research

A collaborative research project involves more than one researcher and may involve researchers affiliated with different institutions. Participating researchers and institutions share the responsibility for safeguarding the rights and welfare of human subjects and compliance with applicable regulations.

  • Projects Involving More Than One UI&U Researcher. The IRB application and review process for research studies involving more than one UI&U researcher is the same as the process for projects with a single researcher. Be careful to describe any differences in researchers’ roles and responsibilities and to design an informed consent process that clearly identifies all researchers.
  • Projects Involving Researchers Affiliated with Another Institution or Organization. When a UI&U researcher engages in a study with someone from another organization or institution, the project should have a lead institution—usually the organization where the primary investigator is affiliated. Such projects typically require approvals from more than one IRB. When possible, students involved in collaborative projects as a component of their degree program should obtain the approval of the external organization’s IRB prior to applying for approval from UI&U’s IRB. If prior approval is not possible, the IRB may approve the proposed study but will not permit it to begin until the student provides documentation of approval of the other IRB.

6.H. Certification of Research

External funding for a research study may require IRB certification of the project, even when no human subjects are involved. The IRB certifies projects through formal notification to the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services or to the applicable nongovernmental funding department / agency. For collaborative research involving more than one institution, only the IRB at the lead institution may file for certification with the OHRP. Proposed research for which the principal researcher requests IRB certification must be reviewed and approved by the full IRB, even when it qualifies for exempt review.

6.I. Suspension or Termination of IRB Approval

The IRB has the authority to suspend or terminate IRB approval of research involving human subjects for any of the reasons listed below. Researchers are obligated to halt their research immediately if they receive a notice of IRB suspension or termination of IRB approval.

The decision to suspend or terminate IRB approval of a research project may stem from the IRB’s charge from the university’s Board of Trustees, from the IRB’s responsibilities to human subjects, from the obligations of an OHRP-registered IRB, from our commitment to the protection of human research subjects evidenced by a Federalwide Assurance, or from IRB policies and procedures. The IRB is required to and will suspend or terminate IRB approval for research if it determines that:

  • Any portion of the research project is being conducted without IRB approval, when IRB approval is required;
  • IRB-approved research continues beyond the end date of IRB approval;
  • The research study is substantively different from what was approved by the IRB; or
  • Subjects of the research have been harmed as a result of the research.

The IRB may suspend IRB approval of a research study based on information provided by someone other than the researcher. In fact, as a member of the academic community, researchers are obligated to notify the IRB Director immediately if they have a concern about the conduct of research involving human subjects or the safety of those subjects. Notices of suspension or termination of IRB approval will be sent to other interested parties such as a faculty advisor, dissertation chair, dean, or funding agencies, if any. In emergency situations, such as when a subject has been harmed, the IRB Chair has the authority to suspend research. The IRB is not required to investigate or consult with the researcher prior to suspending IRB approval of a research study. In fact, in many cases, it will not do so. In emergency situations, notice of suspension of IRB approval may be made by telephone or e-mail.

This list is based on Title 45 CFR Part 46.101.

“Categories of Research that May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review.” Available from http://www.hhs.gov/ohrp/policy/exprev.html.

Extracted from 45CFR46.110. Available from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

The IRB may approve internal assessment research projects conducted by or on behalf of university administrative or academic units for up to 24 months. See “Class-Related and Other Research Activities.”

Source: Guidance on Continuing Review, dated January 15, 2007, available at http://www.hhs.gov/ohrp