1. What Level of Review Does my Project Require?
CONVENED/FULL BOARD
EXEMPT
EXPEDITED
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2. This video will discuss how to determine what level of review is required for applications submitted to the HRPP/IRB.
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3. This video will go through the three levels of review
This video will go through the three levels of review. Providing information as to the types of research that would require exempt, expedited, or full board review. To assist researchers with applying these review types, quizzes have been included in this video. Please note that quiz results may be used in aggregate form for HRPP program evaluation purposes.
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4. This video will not go into detail regarding the review categories for each review type. Instead categories for each review type will be summarized. If you have any questions about a specific review category please go to the CUNY HRPP Website and see policies regarding Exempt, Expedited, and Full Board review. Additionally as this video will be referring to and building on our video “Does My Project Require HRPP/IRB Review?” it is recommended that you view this video first.
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5. Levels of Risk for Exempt, Expedited, and Convened/Full Board Research*
Minimal Risk – A risk is considered minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The HRPP/IRB must determine that a research study is minimal risk in order for that project to meet exempt or expedited review criteria.
Greater Than Minimal Risk – Are research procedures that may include risks beyond that ordinarily encountered by subjects. Greater than minimal risk studies require Convened/Full Board Review.
*Parts of these definitions are bolded for emphasis
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6. What does Exempt Review Mean?
Exemption is a review type for projects that meet the human subjects and research definitions but can be “exempt” from the regulations that govern projects requiring IRB Review (45 CFR ) such as expedited and convened/full board projects.
Exempt Projects are considered minimal or low risk studies that will not cause more than minimal harm or discomfort to study participants.
Exemptions do not apply to research involving prisoners, or children except where research involves only observations where the investigator does not participate in or manipulate the activities being observed.
To qualify for exempt status research procedures must fall within the six exemption categories set forth in 45 CFR (b).
Per CUNY Policy, Researchers can not make an exempt determination. Exempt Applications must be sent to and approved by the HRPP Office. HRPP Staff will also apply the ethical guidelines set forth in the Belmont Report to exempt projects as these projects are not exempt from these guidelines.
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7. Exemption Categories*
Research Conducted in Established or Commonly accepted educational settings, involving normal procedures including regular and special education instructional strategies and effectiveness/comparison of instructional techniques, curricula, or classroom management techniques.
Research using anonymous or minimal/low risk educational tests, surveys, interviews, or observation of public behavior. Note that Children can only be observed with no interaction or intervention from the researcher.
Same as Category 2 however this category refers to Public Officials or Candidates (elected or appointed)
Research involving the collection or study of existing data if it is publically available or if subjects can not be identified.
Research examining public service programs.
Taste and Food Quality and Consumer Acceptance studies
*The categories listed above have been summarized to see full exempt category descriptions please go to the CUNY HRPP Website.
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8. Types of Exempt Research*
Research involving existing data or specimens recorded anonymously or publically available. Note that studies that exclusively are analyzing de-identified/publically available datasets are not considered “human subjects” research and do not require review.
Surveys, interviews, and public observation research that are anonymous or do not have risks to subjects of criminal/civil liability or could be damaging to subjects financial standing, employability or reputation.
Research designed to study or examine public benefit or service programs.
Research conducted in commonly accepted educational settings regarding normal educational practices.
* Exemptions do not apply to research that involves or collects sensitive identifiable information from subjects such as sexual history or illegal behavior. If your project involves the collection of sensitive information then it will likely not meet exemption criteria. Additionally those projects that involve deception will likely not meet exemption criteria.
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9. What Does Expedited Review Mean?
Expedited Review does not mean “fast” but is a review type for minimal risk studies that don’t meet exemption criteria.
Like Exemptions, Expedited is a review type for projects that meet both the research and human subjects definitions. However, Expedited Projects must receive IRB Review and are subject to the regulations set forth in 45 CFR
There are nine Expedited Review Categories that include research utilizing medical devices or clinical drug studies, research involving materials (data, documents, records or specimens) that have been collected or will be collected for non-research purposes or data from voice, video, digital, or image recordings. Expedited Review categories apply regardless of the age of subjects except as noted in the category descriptions.
Per CUNY Policy, Expedited Projects require IRB Review and Approval. Expedited Applications are usually sent to one IRB Member for review.
Projects that were initially reviewed by Convened/Full Board can be determined by the IRB to be expedited (Categories 8 and 9) when certain conditions are met. See CUNY Expedited Policies and Procedures for details.
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10. Expedited Review Categories*
Clinical studies of drugs and devices when certain conditions are met
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts.
Prospective Collection of Biological Specimens for Research Purposes by Non-Invasive Means
Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Continuing Review for initial review was conducted by convened IRB if certain conditions are met.
Research not conducted under an investigational new drug application or investigational device exemption where categories two through 8 do not apply but IRB has determined and documented that the research involves no greater than minimal risk and no additional risks have been identified.
*The categories listed above have been summarized to see full expedited category descriptions please go to the CUNY HRPP Website.
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11. Examples of Expedited Research
Projects collecting data, voice, video and scans (For example utilizing EEG or fMRI scans).
Minimal Risk Research that utilizes deception by either withholding information regarding purpose of research or by intentionally providing misleading or false information.
The analysis of identifiable data collected for non-research purposes such as academic data, medical records, or specimens.
Observational Studies in which the PI interacts or intervenes with human subjects.
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12. What does Convened/Full Board Review Mean?
There are three main reasons why a project may require Convened/Full Board Review:
Project procedures that may pose greater than minimal risk to subjects.
Projects that may pose no greater than minimal risk to subjects but does not appear in any of the categories of research that can be reviewed under Expedited Review Procedures. CUNY UI IRB would initially review these types of projects but can determine that projects may undergo expedited review procedures during continuing review.
The convened board may also review and take action on unanticipated problems, allegations of serious or continuing non-compliance, and subject complaints.
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13. Types of Studies that could necessitate Convened Board Review
Research studies that can result in emotional stress such as asking questions related to subjects’ personal experiences such as sexual or physical abuse, divorce, etc.
Studies that have risks due to breach of confidentiality such as a research study that collects identifying information and asks subjects about illegal activities such as drug use, or crimes committed.
Studies that seek to recruit/enroll Prisoners may be subject to CUNY UI IRB Review.
Studies that may contain procedures that subject participants to pain, discomfort, or injury.
Studies where sensitive data and subject identifiers have been collected.
Transcranial direct current stimulation (tDCS) and Transcranial magnetic stimulation (TMS) studies.
FDA Regulated Studies such as those studies that are Investigational Device, Investigational Drug, or Biologics Studies.
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14. Mitigating Risks in Research
There are many ways that a PI can mitigate risks in studies:
Psychological Risk – a research activity or experimental condition could result an emotional stress which depending on the amount or level of emotional stress cold be considered more than minimal risk. Researchers should try to reduce potential emotional distress. One way to reduce emotional distress would be by having information on hand such as directing study participants to counseling centers. If there is a greater than minimal risk of emotional distress to study participants having an counselor on site to assist study participants.
Invasion of Privacy & Breach of Confidentiality – This is a common risk especially with those who conduct research online. Reducing this risk by appropriately protecting confidentiality or using data collection procedures that would make it impossible to link any identifying information with subjects’ responses or data. Additionally if you are obtaining documented (signed) consent, assent, and/or parental permission the forms should always be kept in a secure location separate from data.
Vulnerable Populations – Risk Groups such as the elderly, mentally disabled persons, economically or educationally disadvantaged persons, or persons with diseases and psychiatric disorders should be given special consideration depending on the type of the study being conducted. Special Vulnerable Groups that are covered by the federal regulations (e.g. children/minors, prisoners, pregnant women, etc). It is important that the researcher ensure that any vulnerable person participating in a research study is appropriate for inclusion in the study. The vulnerable person and/or their surrogate must make an informed decisions about whether or not the individual wants to participate.
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15. Conclusion
The determination of the level of review required is made by the HRPP/ IRB not by researcher. However, being knowledgeable about the review types will decrease the workload of researchers.
Research activities described in either the exempt and expedited categories are merely eligible for these review types/categories. The HRPP/IRB will make determinations as to whether or not the proposed research involves no more than minimal risks to human subjects and meet the exempt or expedited criteria.
Convened Review are for projects that don’t meet either exempt or expedited criteria. Additionally, unanticipated problems, allegations of serious or continuing non-compliance, and subject complaints are reviewed by the Convened IRB as well.
PI’s should always try to mitigate risks to subjects by ensuring that they are collecting the data needed for their studies, storing and protecting data in a secure way making sure to limit access to only research personnel, and making sure that risks to subjects are minimized. Collecting minimal (or no) demographic or identifiable information that could directly or indirectly identify participants is an additional way of minimizing risk.
If you have any questions as to the level of HRPP/IRB review required then please contact the Baruch HRPP Coordinator.
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16. HRPP Services
Application Assistance – This includes assistance with the development and submission of an IRB Application on IDEATE our on-line system. HRPP Liaisons and Assistant are available to assist researchers with the development of their proposals. Please go to our website and click on the Investigators Assistance link for further details.
Departmental/Classroom Presentations – The HRPP Office will conduct department/classroom presentations in consultation with departmental chairs , faculty members, and instructors. Please contact the HRPP Coordinator, who will assist with setting up a presentation.
Guidance regarding HRPP Policy and Procedures – The HRPP Coordinator will assist researchers with interpreting CUNY policies and procedures to ensure compliance. This includes but is not limited to assisting investigators with determining whether or not their project requires HRPP/IRB Review, assessing the level of review, or navigating researchers through the CUNY IRB process.
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17. HRPP Videos
Step-by-Step Series – These videos will go step-by-step through the IDEATE Application by exempt and expedited/full board review types.mpliance/human--research-1.html
Creating a Satisfactory IRB Application – This video discusses the elements of creating an IRB Application providing tips to assist researchers in developing and submitting a satisfactory IRB Application.
Faculty Advisor Responsibilities – This video discusses faculty advisor responsibilities providing tips to ensure student compliance with CUNY Policies and Procedures.
Assessing the Level of IRB Review Series – These videos will help faculty advisors and researchers with determining the level of IRB Review required for IRB Applications.
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18. Useful Links CUNY HRPP Website
Baruch HRPP Website
CUNY Templates & Resources Materials
CUNY HRPP Website
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19. HRPP Office Staff Keisha Peterson, HRPP Coordinator
Telephone:
Priyanka Mitra-Hahn (Psychology), HRPP Liaison
Jill Douek (Psychology), HRPP Assistant
To view HRPP Staff office hours please go to the Baruch HRPP Office website and click on the Investigators Assistance Link.
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