IRB - Institutional Review Board - Submission Information

Submission Information

It is the reviewer’s responsibility to determine if the application requires an exempt, expedited, or full review. Review the information on each of the respective pages. The Institutional Review Board has the discretion to do a full review of an expedited application if the risks are significant. ALL research involving children requires Full Review.

Data from human subjects are not to be collected until approval is received from the Institutional Review Board.

Submitting Applications

IRB applications must be submitted to the IRB by the Principal Investigator who must be a member of the faculty/staff. Submissions made by students will be returned.

Applications must be submitted electronically via the Cayuse system. Email submissions will not be accepted.

Application status can be viewed in Cayuse. Change of status, renewal, and final reports can be submitted through this system.

Cayuse Signup

Students should check with their instructor to see if they have been added to the Cayuse system. If not, click here to register with Cayuse. Once you login through CAS, you should receive an email confirming your registration and granting you access to Cayuse within 24 hours.

Questions?

Contact us for questions about the process.

Exempt Review

Exempt applications must be submitted through the Cayuse system.* Email submissions will not be accepted.

Exempt application instructions and questions can be found on the following documents:

Most exempt applications use Implied Consent. The purpose of the Implied Consent document is to offer your participants the opportunity to make an informed decision about whether or not they would like to participate in your research project. The Implied Consent document should be written at the 9th grade level and should be directed towards the participant. Implied Consent

*Students should check with their instructor to see if they have been added to the Cayuse system. If not, go to this website www.fortlewis.edu/irbsignup to register. Once you login through CAS, you should receive an email confirming your registration and granting you access to Cayuse within 24 hours

In order to qualify for exemption, all of the project activity must qualify as one or more categories from the left column below. To qualify for a category, a project must meet the conditions to the right of the category.

Category Conditions
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

(a) Research on regular and special education instructional strategies,

OR

(b) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, if:

 

NOTE: all three conditions must apply.

(a) Information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects;

AND

(b) 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 subject's financial standing, employability, or reputation;

AND

(c) Subjects are not under the age of 18 or members of a vulnerable class, including prisoners, pregnant women, individuals who are mentally disabled or economically or educationally disadvantaged.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) above if:

(a) The human subjects are elected or appointed public officials or candidates for public office;

OR

(b) Federal statutes(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if:

 

(a) These sources are publicly available;

OR

(b) 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) 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

 

(a) Public benefit or service programs;

OR

(b) Procedures for obtaining benefits or services under those programs;

OR

(c) Possible changes in or alternatives to those programs or procedures;

OR

(d) 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, if:

(a) Wholesome foods without additives are consumed;

OR

(b) 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 USDA.

Expedited Review

Expedited review applications can be submitted anytime. Only one member of the Institutional Review Board needs to review these applications. You will receive notification within 7-10 working days after submission asking for more clarification, granting approval or denial. Once the concerns have been satisfactorily addressed, an approval notice will be sent to both the researcher and the co-PI (student).

Expedited Applications must be submitted through the Cayuse system. Email submissions will not be accepted.

Expedited application instructions and questions can be found on the following documents:

At the end of your study you should submit your final report via Cayuse.* Additionally, change of status and renewals should be submitted via Cayuse.

**Students should check with their instructor to see if they have been added to the Cayuse system. If not, click here to register with Cayuse. Once you login through CAS, you should receive an email confirming your registration and granting you access to Cayuse within 24 hours.

**Any changes to applications submitted via email under the old system (prior to fall 2016) must use the Change of Status/Annual Review form and submit it via email.

Data from human subjects are not to be collected until approval is received from the Institutional Review Board.

Review the following information to determine if your research qualifies for an expedited review.

  1. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.  The activities listed should not be deemed to be of minimal risk simply because they are included on this list.  Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
  2. The categories in this list apply regardless of the age of subjects, except as noted.
  3. The expedited review procedure may not be used where 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.
  4. The expedited review procedure may not be used for classified research involving human subjects.
  5. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convene--utilized by the IRB.
  6. Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories

  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 risks 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 no occur more frequently than 2 times per week; or
     
    (b)  From other adults and children[1][LB1]  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 devise are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
     
  5. 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 subject 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, 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.
     
  6. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).  (NOTE: 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 listing refers only to research that is not exempt.)
     
  7. Collection of data from voice, video, digital, or image recordings made for research purposes.
     
  8. 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).  This listing refers only to research that is not exempt.)
     
  9. Continuing review of research previously approved by the 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 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.
     
  10. 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.
 
[1] Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 CFR 46.402(a).  In Colorado a child is under age 18.
[LB1]

Full Review

A full review is required for research that involves more than minimal risk or that includes protected populations, such as children, prisoners, individuals with disabilities, pregnant women, or any other potentially vulnerable populations. The full review application must be submitted via Cayuse to the IRB committee and will be reviewed at a committee meeting. The primary investigator/co-investigator is expected to attend this meeting. This is a more extensive review process than expedited or exempt applications and thus is longer in duration.

Full Applications must be submitted through the Cayuse system. Email submissions will not be accepted.

Full Application instructions and questions can be found on the following documents:

You will receive an e-mail following this meeting asking for more clarification, granting approval or denial. Once the concerns have been satisfactorily addressed, an email approval notice will be sent to both the researcher and the co-PI (student). Researchers are encouraged to attend meetings when their proposals are being discussed.

If you submitted your application via Cayuse, at the end of your study you should submit your final report via Cayuse. Additionally, change of status and renewals should be submitted via Cayuse.

*Students should check with their instructor to see if they have been added to the Cayuse system. If not, click here to register with Cayuse. Once you login through CAS, you should receive an email confirming your registration and granting you access to Cayuse within 24 hours.

**Any changes to applications submitted via email under the old system (prior to fall 2016) must use the Change of Status/Annual Review form and submit it via email.

Data from human subjects are not to be collected until approval is received from the Institutional Review Board.