Valparaiso University's Institutional Review Board (IRB) is an official committee of the University. The IRB is designed to meet all appropriate laws and regulations of the federal government for research using human subjects. Members and investigators are expected to be familiar with said guidelines. Federal guidelines are considered minimum standards. Institutions and IRBs typically have additional rules, regulations, and policies that may be more restrictive, require higher levels of ethical conduct, or are deemed necessary to accomplish their mission.
The purpose of the IRB is to minimize the risk and ensure informed consent procedures to human subjects participating in research conducted by the faculty, staff, students, and other professionals connected with Valparaiso University. The processes used by the IRB are in accordance with the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46), the Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) regulations. The IRB functions to assess the scientific merit of research and its methods, to promote fully informed and voluntary participation by potential subjects who are capable of making such choices (or if that is not possible, to ensure informed permission given by a suitable proxy), and to maximize the safety of subjects once they are enrolled in a project.
"Human subject" means a living individual who becomes a participant in research and whom an investigator conducting research obtains (a) data through interventions or interaction with the individual, or (b) identifiable private information.
The IRB is guided by the principles outlined in the Belmont Report that defines three basic principles related to research on human subjects. These principles are: (a) respect for person, (b) beneficence, and (c) justice. Respect for the person involves the autonomy of an individual to consent to participate in research activities and the need to protect an individual with a diminished capacity for autonomy (i.e. the mentally ill, minors, prisoners). This includes writing a consent form at a level and a language the potential research subject can understand. Beneficence involves doing no harm and ensuring that the benefits of the research outweigh the possible risks. Justice requires that the potential research subject be treated fairly. This means that no particular class of people is more likely to be selected than others so that a representative sample of potential subjects is included in the study.
Authority of the IRB
The Valparaiso University IRB holds the authority to:
Researchers may not proceed with their research until given final approval by the IRB.
Categories of Review
Federal regulation categorizes planned human subjects research into three categories: research requiring a full review, research that is exempt and research that is expeditable. All protocols must be reviewed by the Chair of the IRB who establishes the appropriate category of review. Only the IRB can establish if a study is exempt or expeditable.
Exempt and Expedited Requests
A. Categories of Exempt Research
The following are the seven categories of exempt research as specified by the HHS.
Category 1 Exemption: Normal Educational Practices and Settings
Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2 Exemption: Anonymous and Educational Tests, Surveys, Interviews, or Observations that does NOT Pertain to a Person’s health
Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures or observational of public behavior, unless; (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Category 3 Exemption: Anonymous and Educational Tests, Surveys, Interviews, or Observations when the Information Pertains to Health
Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures or observational of public behavior as long as the subjects cannot be identified, directly or through identifiers linked to the subjects.
Category 4 Exemption: Identifiable Subjects in Special Circumstances
Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedure, or observations of public behavior that is not exempt if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statues(s) require (s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Category 5 Exemption: Public Benefit or Service Programs
Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or service under those programs; (iii) possible changes in or alternatives to those programs or procedures; (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Category 6 Exemption: Taste and Food Evaluation and Acceptance Studies
Taste and Food quality evaluation and consumer acceptance studies; (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level for a use found to be safe, or to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Category 7 Exemption: Collection or Study of Existing Data
Research involving the collection of study of existing data, documents, records, pathological specimens, 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 inked to the subjects. Note to qualify for this exemption ALL of the data, documents, records, or specimens must be in existence before the project begins.
B. Categories of Expedited Review
The following categories relate to expedited reviews.
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. (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.
Collection of blood samples by finger stick, heelstick, ear stick, or venipuncture as follows; (a) from healthy, non-pregnant 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.
Prospective collection of biological specimens for research purposes by noninvasive means, Examples: (a) Hair and nail clippings in a non-disfiguring 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); and (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 removal at delivery; (g) Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) Supra-andsubgingival dental plaque and calculus, provided the collection procedure is not accomplished in accordance with accepted prophylactic techniques; (i) Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings: (i) Sputum collected after saline mist nebulization.
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 that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subjects or an invasion of the subject’s privacy. (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinoraphy, 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.
Research involving materials (data, documents, records, or specimens) that have been collected for any reason or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be example from the HHS regulations for the protection of human subject 45CFR 46.101(b)(4). this listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings 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. (Note: Some research in this category may be example from the HHS regulations for the protection of human subject 45CFR 46.101(b)(2) and (3). this listing refers only to research that is not exempt.)
Continuing review of research previously approved by a convened IRB as follows: (a) where (i) the research 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 the 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.
Continuing review of research not conducted under an investigational new drug application or investigational drug exemption where categories 2 through 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified or where the remaining research activities are limited to data analysis.
The actions the Chair may approve the study independently, to approve with stipulations, or request additional information. If the Chair evaluates the appropriate action is to disapprove the application instead, the application is forwarded for full review.
For either exempt or expedited review, the Chair may request additional information by telephone or in writing but notifies the investigator of the review process in writing. The Chair may also approve modifications to ongoing studies involving no more than minimal risk. All expedited and exempt reviews are recorded on agendas and in the minutes, typically at the next meeting following review.
If you believe that your planned research meets the Federal criteria for exemption, you will need to submit a summary of your proposed research to the Chair of the IRB and request a determination that the proposed research does qualify as exempt from full IRB review. The request must include a summary of the planned research and procedures and an explicit statement of why you believe the research is exempt. You must complete the exempt application along with your request for exempt review. You may not begin your research until you have received notification that the Chair of the IRB approves the research protocol as exempt.
If you believe your proposal meets expedited guidelines, complete the expedited application and include all required materials. Materials include an informed consent (unless you are seeking an expedited review category that includes a waiver of informed consent), summary safeguard statement, summary of all procedures involving human subjects, and the instrument/s or interview schedule used for the collection of data.
ALL submissions to the IRB must include documentation of successfully completing human subjects’ ethics training. A link to an approved site is available on the web page. However, it is possible to submit documentation from other sources. Contact the Chair of the IRB to clarify if documentation from another source meets the guidelines.
The request for review may be received at any time and a response will be sent back as soon as possible (no more than two weeks during the main academic calendar).
Applicable Regulations and Guidelines
45 CFR 46.101(b)(1)
Family Educational Rights and Privacy Act (FERPA) http://www.ed.gov/policy/gen/guid/fpco/ferpa/index.html
Protection of Pupil Rights Amendment (PPRA) http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. Another charge was to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.