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Institutional Review Board

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Submittable Form


INSTRUCTIONS FOR
APPLICATION FOR APPROVAL OF RESEARCH INVOLVING HUMAN SUBJECTS

 

These instructions are designed to assist researchers in preparing their application for approval of research involving human subjects.  Researchers are also encouraged to refer to IRB Policies (tab on the left side of this website) for additional information about the rules and regulations that inform many of these questions on this application.  Please contact Dr. Jennifer Anderson-Meger, IRB Chair, at jimeger@viterbo.edu with any remaining questions.

REMINDER: IRB approval must be obtained prior to the start of the project.


DOES MY STUDY REQUIRE IRB APPROVAL? 

Any study that meets the federal definition of human subjects research must be approved by the IRB.  Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge.  Human subject is defined as a living individual about whom an investigator obtains data through intervention, interaction, or individually identifiable private information.  Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment.  Interaction includes communication or interpersonal contact between the investigator and the subject.  Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual that he or she can reasonably expect will not be made public. 


TYPE OF REVIEW

Researchers must apply for either exempt, expedited, or full review of their studies.  The following guidelines are provided to assist researchers in determining which type of review is appropriate.  However, upon review of the application, IRB committee members or their designated representatives may determine that a different type of review is needed.

Exempt Status

In general, studies qualify for exempt status if they meet the following conditions:   

  • Research procedures present virtually no foreseeable risk to participants.
  • A vulnerable population (such as children, prisoners, pregnant women, mentally disabled persons or economically/educationally disadvantaged persons) is not used as participants.
  • Information is recorded in such a manner that participants cannot be identified directly or through identifiers linked to the participants and any disclosure of participants' responses outside the research could not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.
  • The study does not involve deception of participants. 

Federal regulations dictate that only the following types of research are eligible for exempt status.  If a study does not fall into one of these categories, even when the above conditions are met, the researcher must apply for expedited or full review.

1. Research involving the use of survey procedures, interview procedures, observation of public behavior, or educational tests (such as cognitive, diagnostic, aptitude, or achievement tests) if either (a) information obtained is recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects and any disclosure of the subjects' responses outside the research could not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation, or (b) the human subjects are elected or appointed public officials or candidates for public office

2.  Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if these sources are publicly available or the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.

3.  Research conducted in established or commonly accepted educational settings involving normal educational practices (such as research on regular and special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods).

4.  Taste and food quality evaluation and consumer acceptance studies if wholesome foods without additives are consumed or a food is consumed that contains an ingredient at or below the level found to be safe by the Food and Drug Administration, the Environmental Protection Agency, or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

5.  Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Expedited Review

In general, studies qualify for expedited review if they meet the following conditions:  

  • Research procedures present no more than a minimal risk to participants.  Minimal risk is defined by federal regulations as meaning 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. 
  • A vulnerable population (such as children, prisoners, pregnant women, mentally disabled persons or economically/educationally disadvantaged persons) is not used as participants.
  • Identification of the participants and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing.
  • The study does not involve deception of participants. 

Federal regulations dictate that only the following types of research are eligible for expedited review.  If a study does not fall into one of these categories, even when the above conditions are met, the researcher must apply for full review.

1.  Research on individual/group characteristics or behavior (such as 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.

2.  Collection of data from voice, video, digital, or image recordings made for research purposes.

3.  Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

4.  Clinical studies of drugs for which an investigational new drug application is not required and clinical studies of medical devices for which an investigational device exemption application is not required or the medical device is approved for marketing and the medical device is being used in accordance with its approved labeling.

5.  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults who weigh at least 110 pounds when the amount drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week or from other adults and children when 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.

6.  Prospective collection of biological specimens for research purposes by noninvasive means.  Examples include: hair and nail clippings in a nondisfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); 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; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; 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; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; and sputum collected after saline mist nebulization.

7.  Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.  Examples include: 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 subject or an invasion of the subject’s privacy; weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; and moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Full Review

Studies require full review if they meet any of the following conditions: 

  • Research procedures present more than a minimal risk to subjects.  Minimal risk is defined by federal regulations as meaning 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.  
  • A vulnerable population (such as children, prisoners, pregnant women, mentally disabled persons or economically/educationally disadvantaged persons) is used as participants.
  • Identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing.
  • The study involves deception of participants. 

PROJECT INFORMATION

In this section, researchers should provide basic information about the study.


RISKS

In this section, researchers should describe the possible risks to participants, keeping in mind that risks might include physical injury, psychological stress, emotional comfort, or disclosure of sensitive information.


VOLUNTARY PARTICIPATION

In this section, researchers should describe the procedures that will be used to ensure the voluntary participation of subjects.


CONFIDENTIALITY

In this section, researchers should describe the methods that will be used to protect the confidentiality of participants' information.


SUPPORTING MATERIALS

Each application must be accompanied by the following documents.  They should be submitted via email to irb@viterbo.edu at the time of application.

Informed Consent Form

Federal regulations require that the informed consent form contain the following information:    

  • An explanation of the purpose of the research and a description of the procedures to be followed, including the expected duration of the subject's participation
  • A description of any reasonably foreseeable risks or discomforts to the subject
  • A description of any benefits to the subject or to others which may reasonably be expected from the research
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
  • A description of the extent to which confidentiality of records identifying the subject will be maintained
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights or in the event of a research-related injury to the subject
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Samples are available at the IRB Home website to assist researchers in preparing a legally effective informed consent form.

Research Proposal

In most cases, researchers will be expected to submit a research proposal that includes (a) an abbreviated (3-5 page) literature review, (b) a detailed description of the research methodology, and (c) the research instrument (such as questionnaire or interview script) to be used for data collection.  However, it may not be possible for researchers to submit a full proposal for some projects.  For example, it would be difficult to prepare a full proposal for a class project that utilizes a survey comprised of questions submitted by each student to examine his/her individual research question.  In these rare cases, researchers will be required to submit only the research instrument to be used for data collection.  However, IRB reviewers reserve the right to request a full proposal if they believe it is feasible for the researcher to provide one.

Additional Materials

Any additional materials that will be supplied to participants must be included as part of the application.  Examples might include recruiting flyers and letters or emails inviting individuals to participate.

Certification of Training

All principal investigators submitting studies for review must have completed IRB training within the last three years.  Viterbo University currently uses the training module available through the National Institute of Health.  A link to this site is also available on the IRB homepage.  Researchers who successfully complete the training will receive an electronic certificate that must be submitted with their application.  Researchers who have completed the training within the last three years will only need to submit the date when the certificate on file was originally issued.


RESEARCHER’S ASSURANCE

Researchers must agree to the terms of IRB approval by providing their name and ID number, which may be found on the Viterbo University ID card.


WHAT HAPPENS AFTER MY APPLICATION IS SUBMITTED?

Applications for exempt status are reviewed by one IRB committee member or designated representative.  Researchers may expect to be notified of the decision within one week.  Applications for expedited review are reviewed by two IRB committee members.  Researchers may expect to be notified of the decision within two weeks.  Applications for full review are reviewed by the entire IRB committee.  Researchers may expect to be notified of the decision within four weeks.

If an application is approved as submitted, the researcher may begin data collection immediately upon notification.  If an application is conditionally approved pending submission of revisions or additional information, the researcher must submit the requested information and wait until it have been reviewed and approved before data collection may begin.  If an application is denied, the researcher will be provided with a reason for the decision.  If a reviewer believes an application for exempt status should receive expedited review, the researcher will be notified and the proposal will be forwarded to an additional IRB committee member for review.  If a reviewer believes an application for exempt status or expedited review should receive full review, the researcher will be notified and the proposal will be added to the agenda for the next committee meeting.   



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