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Completing the iRIS Application

Access to iRIS requires registration: See How to Access iRIS for the First Time .

iRIS uses smart form logic: The New Study application is composed of a number of sections. Within some of these sections are “branching” questions which will trigger the display or repression of additional sections depending on they are answered.

To save information in the application, click the “Save and continue to the next section” button found at the top right corner of the screen. You must click the save button; the information is not automatically saved.

Submissions Review Process

The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects ( 45 CFR 46.111 ).

The IRB will give proper consideration to:

  1. The risks to the subjects;
  2. The anticipated benefits to the subjects and others;
  3. The selection of subjects is equitable;
  4. The importance of the knowledge that may reasonably be expected to result;
  5. The informed consent process to be employed; and
  6. The confidentiality of data and privacy of subjects.

The IRB has the authority to approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations. The IRB has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with serious harm to subjects. The IRB has the authority to observe or have a third party observe the consent process and/or the research if the IRB determines it to be indicated.

All projects that meet the federal definition of research with human subjects must be reviewed and approved, or receive an exempt determination, by an IRB prior to beginning the research . The IRB staff initially screens submissions to determine the completeness and the appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.

There are three types of review paths for an IRB application:

The Office for Human Research Protections [OHRP] provide decision charts to researchers and others to decide whether or not an activity involves human subjects and the appropriate review type.

Exempt Review

University policy require researchers to submit their studies for IRB review and final determination by the IRB. Key information about exempt research studies:

  • Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations.
  • Studies that qualify for exemption must be submitted to the IRB for review before starting the research.
  • Researchers do not make their own determination as to whether a research study qualifies for an exemption — the IRB issues exemption determinations.
  • There is no separate IRB application form for studies that could qualify for exemption – the appropriate protocol template for human subjects research should be filled out and submitted to the IRB in iRIS.
  • Although there are eight HHS exempt category regulations, BYU has opted to implement six of those categories at this time (see the list below). Of the six exemption categories listed below, only exemption category 6 (for taste and food quality evaluation and consumer acceptance studies) applies to studies that are FDA-regulated.
  • Studies that qualify for an exemption do not undergo continuing review.
  • Exemptions do not apply to research with prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners. [45 CFR 46.104(b)(2)].
  • Exemption 2(iii) and Exemption 3 do not apply to research with children.

Category 1

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Examples:

  • Evaluating the use of accepted or revised standardized tests
  • Testing or comparing a curriculum or lesson
  • A program evaluation of pharmacy continuing education

Category 2

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

Research involving survey or interview procedures is not exempt when children are subjects. Research involving observation of public behavior is exempt only if the researcher does not participate in the activities being observed.

  1. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot be readily ascertained, directly or indirectly through identifiers linked to the subjects; OR
  2. Any disclosure of Human Subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
  3. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review.

Examples:

  • Surveying teachers, nurses, or doctors about a technique or an outcome
  • Interviewing managers about a management style or best practice
  • Conducting a focus group about an experience or an opinion of a community program

Category 3 (Does not apply to minors in research)

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

  1. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot readily be ascertained, directly or indirectly, through identifiers linked to the subjects; OR
  2. Any disclosure of the Human Subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
  3. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review.

(i) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

(ii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Example:

  • Healthy adult subjects are asked to take part in two two-hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software. The procedures are conducted during a single visit, and subjects are encouraged to take breaks when desired.

Category 4

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

  1. The identifiable private information or identifiable biospecimens are publicly available; OR
  2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; OR
  3. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164 (HIPAA), subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); OR
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Note: Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records, or existing repositories of clinical specimens. No contact between investigator and subject is allowed. If an investigator wants to collect information/specimens directly from research subjects, then another IRB review path will be required. Exemption Category 4(iii) only applies to the use of data (when HIPAA applies) and not to biospecimens.

Example:

  • A researcher is given two datasets that contain private, identifiable information. The researcher uses the identifiers to merge the two datasets but strips the resulting (merged) data of identifiers immediately after the merge and before conducting data analysis. The resulting data used for the analysis is completely de-identified with no link to identifiers.

Category 5

Research and demonstration projects which are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine: public benefit or service programs, including 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.

(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Category 6

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 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 or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the Dept. of Agriculture

Expedited Review

Federal regulations ( 45 CFR 46.110 ) authorize the use of an expedited review process for:

  • Minimal risk human subjects research that meets one or more of the OHRP Expedited Review Categories
  • Minor IRB Amendments approved by the full board
  • Applications qualifying for expedited review are accepted and reviewed on a continuing basis.

Expediting reviewers are experienced IRB members appointed to the role by the IRB Chair or designee. The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise), including in cases of disapproval. Only the full board has the authority to disapprove a study.
Note: Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Categories eight (8) and nine (9) pertain only to continuing IRB review.

Category 1

Clinical studies of drugs and medical devices only when condition (a) or (b) is met:

  1. 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 risks associated with the use of the product is not eligible for expedited review.)
  2. 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.

Category 2

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

  1. 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
  2. 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.

Category 3

Prospective collection of biological specimens for research purposes by noninvasive means.

Examples:

  • 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);
  • un-cannulated 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;
  • sputum collected after saline mist nebulization.

Note: On October 4, 2010, OHRP clarified that it agrees with the FDA’s position that the following procedures are considered noninvasive:

  • Vaginal swabs that do not go beyond the cervical os;
  • Rectal swabs that do not go beyond the rectum; and
  • Nasal swabs that do not go beyond the nares.

Category 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:

  • 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 subjects 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;
  • moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Category 5

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).

  • Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4).
  • This category includes materials that were previously collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research.
  • The phrase “…or will be collected solely for non-research purposes” pertains to the origin of the materials. For example, blood samples that were collected for a clinical test or the results of a course driven exam given in a history class.

Category 6

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

Expedited Review does not apply if identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the 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.

Category 7

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 exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3).

Category 8

Continuing review of research previously approved by the convened IRB as follows:

  1. 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 long-term follow-up of subjects; or
  2. where no subjects have been enrolled and no additional risks have been identified; or
  3. where the remaining research activities are limited to data analysis.

Clarifiers regarding category (a):

  • Closure of enrollment only has to apply to the local site, not to all sites,
  • Long-term follow-up may include research interactions (as opposed to intervention) that involve no more than minimal risk to subjects (e.g., quality of life surveys);
  • Long-term follow-up may include collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a subject for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research protocol.

Clarifiers regarding category (b):

  • “no subjects have been enrolled” means no subjects enrolled at the local site
  • “no additional risks have been identified” means no additional risks identified at the local site or any other institution engaged in the research project or from any other relevant source since the IRB’s most recent prior review.

Clarifiers regarding category (c):

  • The only remaining human subjects research activity is the analysis of data that includes identifiable private information and the IRB reviewer has determined that this activity involves no more than minimal risk.
  • Simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subjects research and thus does not require continuing review.

Category 9

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (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.

Full Board Review

Federal regulations and institutional policy require an IRB Full Board Review for applications where the research involves more than minimal risk to human subjects or has been referred to the committee by an expedited reviewer or the Chair. Regardless of risk level, BYU IRB may require full board review when the research involves:

  • Vulnerable populations, particularly prisoners
  • Sensitive topics, including illegal behaviors which may require an NIH Certificate of Confidentiality [CoC] to protect subject data from compelled disclosure
  • Research involving genetic testing
  • A complex research design requiring the expertise of multiple board members to evaluate

Applications requiring full board review are required to submit by the 10th of the month to be reviewed for the next month’s meeting, the first Thursday of the month. Please refer to the IRB calendar .

IRB staff assign submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. At the conclusion of the meeting, the board votes and issues a determination.