Institutional Review Board (IRB)

IRB PROPOSAL TYPES

ACTIVITIES REQUIRING IRB REVIEW

Human Subject Research

All human subject research at SCU requires IRB review BEFORE the project may begin.

“Research as defined by the DHHS means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

“Human subject” as defined by the DHHS means a living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
• Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and 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, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
• Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
• An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Is your proposal considered “human” “research? See chart below.

This chart is from these HHS Decision Charts. Please see this tool to determine what type of study is proposed: Human Subject Regulations Decision Charts: 2018 Requirements

NIH Decision Tool: Am I Doing Human Subjects Research?

FDA regulations may also apply if the study is FDA regulated and may need an IND or IDE from the FDA before the IRB will be able to approve the study.

• The activity involves the use of a drug (including an approved drug or an over-the-counter drug), other than the use of an approved drug in the course of medical practice.
• The activity involves the use of a medical device (including an approved medical device), other than the use of an approved medical device in the course of medical practice. (Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.
• The data will be submitted to the FDA or held for their inspection

EXEMPTED REVIEW

The SCU IRB will make the determination if the proposal meets the criteria exempting a project from continuing review.  

If the project meets one or more of the categories listed below it may qualify as an exempted study and will not need to have continuing review. Please see the Human Subject Regulations Decision Charts: 2018 Requirements to verify if the project qualifies for exempted review and which category applies.

If a review is undertaken in an expedited format and during the review it is determined that the proposal does not meet the criteria, the project will be referred back to the IRB chair for review by the full convened committee at the next scheduled meeting.

Outcomes of exempted reviews will be reported to the IRB committee at a convened meeting for inclusion in the minutes.

Exempted Research Categories (45 CFR part 46)

Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category.

Use of the exemption categories for research subject to the requirements of subparts B, C, and D. Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows:

• Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met.
• Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners.
• Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D.

Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:

• 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.
• 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:
• 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 through identifiers linked to the subjects;
• 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
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
• 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:
• 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 through identifiers linked to the subjects;
• 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
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
• 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.
• 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.
• 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:
• The identifiable private information or identifiable biospecimens are publicly available;
• 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;
• 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, 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
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch 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.
• Research and demonstration projects that 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 the 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. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
• 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.
• Taste and food quality evaluation and consumer acceptance studies:
• If wholesome foods without additives are consumed, or
• If 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 U.S. Department of Agriculture.
• Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
• Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
• Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
• Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
• An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
• The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Exempted Review Process and Application Packet

Exempted proposals are accepted on a rolling basis. Please see the Human Subject Regulations Decision Charts: 2018 Requirements to verify if the project qualifies for exempted review.

If so, submit the following in the proposal packet to the IRB (include language translation copies for documents that may be provided to subjects or the public as well so they may be reviewed):

• SCU IRB Exempted Application Form or SCU IRB Non-Exempted Application Form
• SCU IRB Informed Consent Form Template and/or HIPPA authorization Form Template
• Or request for waiver as applicable (SCU IRB Informed Consent Waiver Request Form and/or SCU IRB HIPPA Authorization Waiver Request Form)
• Human subjects training certificate for each investigator
• Research protocol
• Proposed recruitment materials (if applicable)
• SCU IRB Experimental Subjects Bill of Rights Form (if applicable)
• Data collection instruments (Screening tools, Survey and/or questionnaires, etc)
• Grant/Sponsor protocol (if applicable)

Submit the “SCU IRB Project Closure Report” within 1 week of the project ending. If an extension of approval dates or modification is required, complete the “SCU IRB Modification Form”.  All research activities must stop when the project reaches the end of the approval period or during any time when modifications are being reviewed until such time as they are approved.

It is the responsibility of the principal investigator to report all protocol deviations, adverse and unanticipated events to the IRB immediately (if life-threatening) or within 10 days (non-life threatening) utilizing either the “SCU IRB Protocol Deviation Form” or the “SCU IRB Adverse or Unanticipated Event Form”.  Below are examples of types of deviations that must be reported to the IRB:

• Adverse events occurring during the research 
• Any accidental or unintentional deviation from the IRB-approved protocol that involved risks or has the potential to recur; (use the protocol deviation report form for this type of event)
• Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a given research subject; (for planned deviations use a modification form)
• Any publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected increase in the risk-to-benefit ratio of the research;
• Any complaint of a subject that indicates an unanticipated risk or which cannot be resolved by the research staff; or
• Any other untoward event that affects the welfare or the privacy, confidentiality or other rights of research subjects or members of their family;
• Any other untoward event that presents a risk to investigators and research staff involved in the conduct of the research.

Reporting to the IRB, appropriate institutional officials, and the department or agency head (i.e., OHRP) for research conducted or supported by HHS, and FDA for FDA-regulated research will occur for any:

• Unanticipated problems involving risks to human subjects or others;
• Instance of serious or continuing noncompliance with the applicable HHS and FDA regulations or the requirements or determinations of the IRB;
• Suspension or termination of IRB approval.

Forms

• SCU IRB Exempted Application
• SCU IRB Informed Consent Template
• Or SCU IRB Informed Consent Waiver Request Form
• SCU IRB HIPAA Authorization Template
• Or SCU IRB HIPPA Authorization Waiver Request Form
• SCU IRB Experimental Subjects Bill of Rights Template
• SCU IRB Continuing Review Report Form
• SCU IRB Modification Request Form
• SCU IRB Adverse or Unanticipated Event Form
• SCU IRB Protocol Deviation Form
• SCU IRB Project Closure Report

CONVENED REVIEW

Full Board Review

All human subjects research involving greater than minimal risk, deceptive studies, and/or involves protected populations (children, prisoners, disabled persons) will be reviewed at a convened meeting of the full board, except when an expedited review procedure is permitted by regulation. It is the responsibility of the investigator to submit all required documents 3 weeks prior to the convened meeting to allow for pre-review by the IRB.

Investigators conducting research that requires a convened review should allow ample time to complete the review process as this review type may take longer than the prior review processes.

If so, submit the following in the proposal packet to the IRB (include language translation copies for documents that may be provided to subjects or the public as well so they may be reviewed):

• SCU IRB Non-Exempted Application Form
• SCU IRB Informed Consent Form Template and/or HIPPA authorization Form Template
• Or request for waiver as applicable (SCU IRB Informed Consent Waiver Request Form and/or SCU IRB HIPPA Authorization Waiver Request Form)
• Human subjects training certificate for each investigator
• Research protocol
• Proposed recruitment materials (if applicable)
• SCU IRB Experimental Subjects Bill of Rights Form (if applicable)
• Data collection instruments (Screening tools, Survey and/or questionnaires, etc)
• Grant/Sponsor protocol (if applicable)

Submit the “SCU IRB Project Closure Report” within 1 week of the project ending. If an extension of approval dates or modification is required, complete the “SCU IRB Modification Form”.  All research activities must stop when the project reaches the end of the approval period or during any time when modifications are being reviewed until such time as they are approved.

It is the responsibility of the principal investigator to report all protocol deviations, adverse and unanticipated events to the IRB immediately (if life-threatening) or within 10 days (non-life threatening) utilizing either the “SCU IRB Protocol Deviation Form” or the “SCU IRB Adverse or Unanticipated Event Form”.  Below are examples of types of deviations that must be reported to the IRB:

• Adverse events occurring during the research 
• Any accidental or unintentional deviation from the IRB-approved protocol that involved risks or has the potential to recur; (use the protocol deviation report form for this type of event)
• Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a given research subject; (for planned deviations use a modification form)
• Any publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected increase in the risk-to-benefit ratio of the research;
• Any complaint of a subject that indicates an unanticipated risk or which cannot be resolved by the research staff; or
• Any other untoward event that affects the welfare or the privacy, confidentiality or other rights of research subjects or members of their family;
• Any other untoward event that presents a risk to investigators and research staff involved in the conduct of the research.

Reporting to the IRB, appropriate institutional officials, and the department or agency head (i.e., OHRP) for research conducted or supported by HHS, and FDA for FDA-regulated research will occur for any:

• Unanticipated problems involving risks to human subjects or others;
• Instance of serious or continuing noncompliance with the applicable HHS and FDA regulations or the requirements or determinations of the IRB;
• Suspension or termination of IRB approval.

Forms

• SCU IRB Non-Exempted Application Form
• SCU IRB Informed Consent Template
• Or SCU IRB Informed Consent Waiver Request Form
• SCU IRB HIPAA Authorization Template
• Or SCU IRB HIPPA Authorization Waiver Request Form
• SCU IRB Experimental Subjects Bill of Rights Template
• SCU IRB Continuing Review Report Form
• SCU IRB Modification Request Form
• SCU IRB Adverse or Unanticipated Event Form
• SCU IRB Protocol Deviation Form
• SCU IRB Project Closure Report

EXPEDITED REVIEW

Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. §46.110 The SCU IRB Chair will make the determination if the proposal meets the criteria for expedited review.

The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. Per this regulation an IRB may use the expedited review procedure to review the following:

• Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk;
• Minor changes in previously approved research during the period for which approval is authorized; or
• Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (d)(8)

Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in. §46.108(b)

Applicability

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.

The categories in this list apply regardless of the age of subjects, except as noted.

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.

The expedited review procedure may not be used for classified research involving human subjects.

Categories of Research that May Qualify for Expedited Review

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
1. (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.)
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.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
1. (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
2. from other adults and children [2], 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 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.

5. 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.)
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
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). This listing refers only to research that is not exempt.)
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.

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.