Categories of Review

There are three categories of review for human subject applications:

• Exempt 
• Expedited
• Full 

Exempt Review

All projects involving human subjects research must be reviewed by the Institutional Review Board (IRB). If the research falls within one of the categories itemized below, the project may be determined to be exempt. Projects that qualify as exempt pose no risk to extremely minimal risk to participants.

Federal law specifically requires that an investigator, department chair, and/or other supervisor of an investigator may not make the final determination as to whether a project merits the exempt designation. The IRB has assigned the ORSP to determine whether exempt status is warranted. At its discretion, the ORSP may choose to submit an exempt protocol to other IRB committee members for review.

Exempt projects still must be conducted in accordance with the general principles of human subjects protection. 

Any proposed changes to the research need to be reviewed by the IRB.

Human subjects applications must be reviewed by the committee to confirm that they meet the criteria for exempt status. Once an application is received, the process takes approximately 5-10 business days. 

The revised common rule significantly impacts how minimal risk research is reviewed and as such, the categories of research that qualify for exemption have been expanded and revised. New categories were added and new processes created. The following is a summary of the main changes to exempt research affecting Loyola researchers:

Eight categories qualify proposals as exempt, however, Loyola IRB will only implement exemptions 1-6 at this time:

1) Exemption 1 (45 CFR 46.104(d)(1)) – Educational Strategies, Curricula or Classroom Management Methods - Modified

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.

Most educational research on regular and special educational instructional strategies, and research on the effectiveness of, or comparison among, instructional techniques, curricula, or classroom management methods may be exempt under this category.

Changes to this exempt category include the caveat that there must not be any impact of subject’s opportunity to learn or any negative impact if the research involves an evaluation of the instructors. If the research involves significant time and attention away from the delivery of regular curriculum or withholding of standard educational content, this exemption would not apply. Also, there must be protection against negative impact on employment if instructors are being evaluated. Research involving randomization to a unproven educational technique, or research conducted by supervisors involved in employment decisions may not be approvable under this exemption.

Subject population:

If any subjects are children:

• Investigators must provide a rationale for why a particular age range was selected, indicate their expertise in working with children, describe the adequacy of their facilities for pediatric research, and indicate whether they will have sufficient numbers of children to adequately address the research question.
• All study team members must obtain the required clearances before any interaction with children
• Prisoners may be included only if the research involves a broader subject population that only incidentally involves prisoners.

Privacy & Confidentiality:

• “Anonymous” means that no one can identify the subject at any time.
• “Recorded Anonymously” means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
• “Coded” means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
• Data should typically be recorded anonymously or at least coded.
• When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate.(“Sensitive” information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.).

Other:

• When children are studied in school or other institutional settings, approval from a relevant school official must be submitted to the IRB.
• If educational records may be accessed, see the Office of the Registrar's guidance on FERPA.
• Please note: Loyola IRB has determined that projects involving minors will not be reviewed using the exempt procedures.

2) Exemption 2 (45 CFR 46.104(d)(2)) – Tests, Surveys, Interviews, or Passive Observations of Public Behavior - Modified

The exemption applies to 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) uninfluenced by the investigator if at least one of three criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subject cannot readily be ascertained, directly or through identifiers linked to the subjects;
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 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 (there must be adequate provisions for protecting privacy and maintaining confidentiality).

Subject population:

If any subjects are children:

• Only educational tests or passive observation of behavior with no interaction is permitted
• Investigators must provide a rationale for why a particular age range was selected, indicate their expertise in working with children, describe the adequacy of their facilities for pediatric research, and indicate whether they will have sufficient numbers of children to adequately address the research question.
• All study team members must obtain the required clearances before any interaction with children
• Prisoners may be included only if the research involves a broader subject population that only incidentally involves prisoners.

Procedures:

• Interventions cannot be included.
• Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
• Focus groups can be considered to be open-ended interviews, and may be approved for adults, provided the basic exempt criteria are met.
• Passive observation means that there is no interaction or intervention between the subjects and the study team.
• Public means that the setting or location is accessible to anyone in the general public without the need for any special permissions or privileges. Individuals being observed have no reasonable expectation of privacy.

Privacy & Confidentiality:

• “Anonymous” means that no one can identify the subject at any time.
• “Recorded Anonymously” means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
• “Coded” means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
• Data should typically be recorded anonymously or at least coded.
• When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate.(“Sensitive” information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.).

3) Exemption 3 (45 CFR 46.104(d)(3)) – Benign Behavioral Intervention - New

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 subject cannot readily be ascertained, directly or through identifiers linked to the subjects;
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 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 (there must be adequate provisions for protecting privacy and maintaining confidentiality).
4. 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.
5. 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.

Subject Population:

• This exemption applies only to adult subjects.
• Adults with decisional impairment cannot be purposefully included
• Studies with interventions involving children do not meet the exempt criteria.
• Prisoners may be included only if the research involves a broader subject population that only incidentally involves prisoners.

Procedures:

• Behavioral interventions must be brief in duration. Although there is no specific amount of time that is defined as brief, OHRP guidance suggests the intervention must be brief in nature, even if subsequent data collection takes longer.
• Interventions may not be harmful, painful or distressing. Risk to subjects is low.
• Interventions must be unlikely to have significant emotional discomfort or adverse lasting impact
• Study content and procedures must not be offensive or embarrassing to subjects
• Medical interventions and procedures are not permissible in this exemption
• Physical (bodily) tasks and physical exercise should not be included in this exempt category.
• Deception can only be used if the subject prospectively agrees to the use of deception. Subjects must be informed prior to initiating the intervention that they will be unaware of, or misled regarding the true nature or purpose of the research. They will also be told whether further information will be provided at the conclusion of the research activities. Researchers should consider de-briefing subjects.
• Research procedures in this exempt category should generally be limited to:

• communication or interpersonal contact with the subject,
• the performance of a cognitive, intellectual, educational or behavioral task, or
• manipulation of the subject’s physical, sensory, social, or emotional environment

• Data collection in this exempt category is limited to:

• verbal (oral) or written responses by the subject
• data entry by the subject
• observation of the subject
• audiovisual recording

Privacy & Confidentiality:

• “Anonymous” means that no one can identify the subject at any time.
• “Recorded Anonymously” means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
• “Coded” means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
• Data should typically be recorded anonymously or at least coded.
• When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate. (“Sensitive” information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.).

4) Exemption 4 (45 CFR 46.104(d)(4)) – Secondary Research with Data and/or Specimens - Modified

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;
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;
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, 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 applicable federal privacy standards found in the E-Government Act, Privacy Act and the Paperwork Reduction Act.

Criterion 1 - Publicly available data/specimens:

Publicly available refers to data and/or specimens that are accessible to anyone in the general public, without the need for special permissions or privileges.  In these cases, the subjects do not have a reasonable expectation of privacy of their data/specimens. Examples include data/specimens available for purchase, searchable online, or available at a library.  Researchers may be subject to an agreement with the entity releasing data/specimens.

Criterion 2 - Non-public data:

Non-public data which may or may not contain identifiers but are not clinical data subject to HIPAA regulations.  Study team members may access identifiable private information, but cannot record / obtain data in a way in which it could be linked back to identifiers, even temporarily.  Any individuals accessing the identifiable data must already have access to that information (e.g. by means of their involvement with the original collection).  The data will not be able to be linked to the identity of the subjects at any time.

Criterion 3 - Data subject to HIPAA regulations:

An acceptable method for collection of these data include:

• Direct access to identifiable medical records by the researcher team / Waiver of HIPAA Authorization is required: Identifiable data can be recorded and a waiver of the requirement to obtain signed HIPAA Authorization is requested and sufficiently justified.
• Note that it must be accurately stated in the protocol that the only individuals who will access identifiable data are those who already have access to the identifiable data, related to their job responsibilities, granted by the privacy office.
• The IRB will not approve a waiver of HIPAA Authorization if the data desired are not in some way related to the patient care responsibilities of the listed PI.
• Although it is no longer required that data be “retrospective” as of the date the protocol was submitted, the waiver justifications must pertain to all subject populations, dates, and variables that are to be collected.

Criterion 4 – Research conducted on behalf of Federal Agencies:

Option 4 pertains to research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected data obtained for non-research activities.  The study team must demonstrate compliance with the policies detailed in the regulation, specified above.

The 2018 changes significantly broaden the type of secondary research that can be done under this exemption category:

• The requirement that all study data be existing at the time of IRB submission has been eliminated. Data under this exemption may be both retrospective and prospective.
• The requirement that the study involves data only has been eliminated. The research may also involve the use of specimens.
• Creating a de-identified dataset for analysis is still an approvable option and continues to be the most straight-forward approach.
• If investigators need to retain data that contains any HIPAA elements or need to retain a linking list, then appropriate HIPAA protections could make the project approvable. Depending on the circumstances of the data, the HIPAA protections might include a Business Associate Agreement, a Data Use Agreement or a waiver of HIPAA authorization with accounting of disclosures.
• Certain sources of publicly available data require the recipient to sign an agreement outlining restrictions on access, use, security and transfer. These agreements may need review by general counsel.
• Additional Requirements for all secondary analysis studies:

• The data and/or specimens have been or will be collected for purposes unrelated to the proposed study (e.g. “secondary” analysis).
• Specimens can only be included in Criterion 1 only. However, a “no human subjects” determination can be made for studies involving specimens if criteria are met.
• Note that as of January 22, 2019, it is no longer a requirement that all data/specimens be retrospective (previously collected as of the date the protocol is submitted).
• "Source" of data/specimens refers to the entity (research study, data/specimen bank, lab, external entity, etc.) from which data/specimens will be directly obtained for this study.

Privacy & Confidentiality:

• “Anonymous” means that no one can identify the subject at any time.
• “Recorded Anonymously” means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
• “Coded” means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
• Data should typically be recorded anonymously or at least coded.
• When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate.(“Sensitive” information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.).

5) Exemption 5 (45 CFR 46.104(d)(5))– Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency - Modified

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.

The scope of this category has been broadened. Prior rules required that the Federal demonstration projects be conducted by the Federal agency. This category has been updated to allow projects that are simply funded by a Federal agency. The scope has been expanded to include purposes not only to study and evaluate but also to improve these programs. Note that projects eligible for this exemption will be posted on a Federal website.

6. Exemption 6 (45 CFR 46.104(d)(6)) – Taste and Food Quality Evaluation and Consumer Acceptance Studies - Unchanged

Taste and food quality evaluation and consumer acceptance studies: if wholesome foods without additives are consumed, or 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 U.S. Department of Agriculture

This exemption category was not changed in the revised Common Rule. Note that it is the only exemption that is allowable for FDA-regulated research.

Applicability to vulnerable populations:

• Pregnant women may be included in this type of research.
• Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
• Research involving children is eligible for this exemption.
• Research involving decisional-impaired persons could be allowed if their inclusion was justified.

7. Exemption 7 - NOT CURRENTLY IMPLEMENTED AT LOYOLA - New

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 §__.111(a)(8).

8. Exemption 8 – NOT CURRENTLY IMPLEMENTED AT LOYOLA - New

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 §__.116(a)(1) through (4), (a)(6), and (d);
• Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §__.117;
• An IRB conducts a limited IRB review and makes the determination required by §__.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 479
• 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 any legal requirements to return individual research results.

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Expedited Review

Expedited review may apply to human subjects applications that do not meet the guidelines for exempt review. Research in this category must involve no more than minimal risk for participants.

According to the Office of Human Research Protections (OHRP), minimal risk "means that the probability and magnitude of harm or discomfort anticipated in the research are not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

OHRP guidelines also specify Categories of Research that Institutional Review Boards (IRB) may review through the expedited review process. In addition to the categories provided by OHRP, Loyola University Maryland's Policies and Procedures for Research Involving Human Participants indicate that all human subjects applications involving minors (individuals under 18 years of age) as participants are to be reviewed through the expedited review process.

When an expedited application is received by the ORSP, it is sent to two IRB committee members for review. The expedited review process will take approximately three weeks. The reviewers refer any research protocols that are not approved through the expedited process for a full review. The reviewers also may refer other research applications to the entire IRB whenever either of the reviewers believes that full review is necessary. 

CONTINUING REVIEW REVISIONS
The Final Rule eliminates continuing review for many minimal risk studies. Unless an IRB determines otherwise, continuing review of research is not required if:

• The research was initially approved under expedited review;
• The research is reviewed by the IRB in accordance with the limited IRB review procedure described in several of the exemption categories (specifically 2 and 3 at Loyola); 

Note: Continuing review is currently required for FDA regulated research.

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Full Review

Human subjects applications scheduled for full review are distributed to all members of the Institutional Review Board (IRB) prior to the meeting, along with all relevant correspondence pertaining to the application. Additionally, the Principal Investigator will be invited to present the project to the committee. Consultants or experts also may be invited to the meeting to advise the IRB in its review of an application.

For a research application to be approved, the application must receive the approval of a majority of the IRB members present at the committee meeting.

CONTINUING REVIEW REVISIONS
Annual updates and continuing review is required for all research under full review, however, continuing review of research is not required if:

• The research was initially approved by a convened IRB and has progressed to the point that it involves only one or both of the following activities:
  
  • Data analysis (including analysis of identifiable information or identifiable biospecimens), or
  • Access to follow-up clinical data from procedures that subjects would undergo as part of clinical care.

If an IRB chooses to conduct continuing review even when these conditions are met, the rationale for doing so must be documented.

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