Project Levels of Review

To qualify for exempt level review, the research study must fall into any of eight categories delineated in the federal regulations. The categories represent studies that present minimal risk to subjects. Risk is minimized through anonymity of responses or through the use of non-invasive paradigms that will not harm subjects. This definition of exempt research holds unless the data are both identifiable and potentially harmful if disclosed.

Exempt does not mean the study is exempt from any review by the IRB. It means that the study will not require a full board meeting. Instead, the IRB coordinator and one member of the board will review the proposal. Instead, the IRB coordinator will review the proposal, in consultation with a member of the board, as needed.

Common examples of Exempt level research at SUNY Brockport are:

• Anonymous surveys
• Interviews or surveys of adults that involve minimal risk
• Research of normal educational practices

Note: Specific guidelines apply to children included in research classified as Exempt. The section of this category pertaining to standardized educational tests may be applied to research involving children. This section is not applicable to survey or interview research involving children.

At SUNY Brockport, most studies requiring EXEMPT review fit into one of the following categories:

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or 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 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).
3.  
   1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
      1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or 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 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).
   2. 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.
   3. 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.

Complete list of the Eight Categories of Exempt Research

To qualify for expedited level review, new research must fall into any of nine regulated categories delineated in the federal regulations. The list below includes only research typically done at SUNY Brockport. The full list of all nine categories can be found at OHRP Expedited Review Categories. For research to be reviewed using the expedited review procedure, it must:

• Present no more than minimal risk to subjects
• Involve only procedures listed in one or more of the expedited categories

Expedited level reviews are normally conducted by the IRB coordinator and one or more qualified IRB members.

Common examples of research that may be reviewed at the Expedited level at SUNY Brockport are:

• Studies involving focus groups
• Studies involving some behavioral interventions, such as moderate exercise by healthy volunteers
• Studies involving minors outside of regular classroom activities
• Continued review or modification of an already-approved study

Note: Expedited review is used to review some or all of the research that falls into the federally regulated categories and review minor changes in previously approved research.

The specific circumstances of the proposed research must be considered when determining whether an activity listed above involves minimal risk. The expedited review procedure may not be used for research 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 not greater than minimal.

Common EXPEDITED Review categories at SUNY Brockport

1. 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.
2. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (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.)
3. Collection of data from voice, video, digital, or image recordings made for research purposes.
4. 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.)
5. 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.
6. 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.

Complete List of the Nine Categories of Expedited Research

Proposed research studies involving human subjects that do not qualify for exempt or expedited level review must be reviewed by the IRB at a convened meeting. Studies requiring Full Board review present more than minimal risk to subjects, and/or involve vulnerable populations. The list below includes only research typically done at SUNY Brockport.

Common examples of research reviewed at the Full Board level at SUNY Brockport are studies that include:

• Maximal exercise (VO2 Max) by healthy volunteers
• Institutionalized persons (prisoners, patients in long term care facilities)
• Sensitive topics (criminal behavior, sexuality)

Note: Full Board studies are reviewed on a first come, first served basis by the IRB at scheduled meetings. Our schedule can be found online.

• Research which might put participants at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing
• Research involving psychological or physiological intervention that involves more than minimal risk
• Interviews or surveys on sensitive topics that may pose more than minimal risk (e.g., sexual activity, alcohol or drug use, illegal behavior)
• Studies involving deception, when withholding information or debriefing raises the risk level of the study beyond minimal
• Studies involving populations requiring additional protections because of cultural, economic, or educational vulnerability (e.g., prisoners, adults with mental health issues or developmental delays) whether or not the research is covered by another assurance
• Some secondary analyses of existing data with non-publicly available data that contains private identifiable information about living individuals
• Studies including information that may be disclosed requiring mandatory legal reporting (e.g., child/elder abuse, HIV infection, etc.)
• Studies performed in populations different from the one(s) in whom risks have been identified and the possibility of unknown or increased risk exists (e.g., studies in children involving drugs previously tested only in adults)
• Continuing review of research previously approved by the full board that does not meet the specifications for expedited continuing review

 

The Final Rule preamble states that for certain exempt categories of research, a limited IRB review should be done to ensure that there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data in the proposed research.

• The extent to which identifiable private information is or has been de-identified and the risk that such de-identified information can be re-identified
• The use of the information
• The extent to which the information will be shared or transferred to a third party or otherwise disclosed or released
• The likely retention period or life of the information
• The security controls that are in place to protect the confidentiality and integrity of the information
• The potential risk of harm to individuals should the information be lost, stolen, compromised, or otherwise used in a way contrary to the contours of the research under the exemption

The IRB Coordinator is authorized to determine whether a limited review will be required for proposed research at the Exempt level of review. The Coordinator will complete the limited review along with at least one member of the board.

Note: Continuing review is NOT required for Exempt research requiring Limited Review.

[Refer to sections 45 CFR 46.109(a) and 46.109(f)(1)(ii) of the revised Common Rule for more information about Limited Review.]

The IRB is required to re-evaluate research projects at intervals appropriate to the degree of risk, but not less than once a year. The approval letter from the IRB will indicate the approval and expiration or review dates.

Note: The 2018 revisions to the Common Rule no longer require continuing review for Exempt and Expedited research. However, the IRB may at its discretion require continuing review for expedited research. In such cases, the IRB must provide written justification for mandating continuing review in the IRB approval letter.

It is the investigator’s responsibility to complete the continuation form, attach the appropriate information, and return the package to the IRB in advance of your project’s expiration date if you wish to continue your research. If continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically, and research must cease. Enrollment of new subjects cannot occur after the expiration of IRB approval. If IRB continuation period has expired and you wish to continue your research, you will need to submit your project as a new study.

Submission

Continuations for proposals in all categories of research (exempt, expedited and full board) should be requested through PACS.

All modifications submitted should include the original approved IRB documents, with changes highlighted, and the new documents reflecting all proposed changes.

Under the University’s guidelines, a maximum of two consecutive continuations can be granted to faculty and staff research projects. After two continuations, the project must be resubmitted to the IRB as a new protocol for review and approval. Student projects may receive more than two continuations depending on the project’s timeline.

If your project was originally reviewed via full board review, your continuation and/or modification request will not require full board review if they meet one of the following guidelines:

• Continuing review of research previously approved by the convened IRB as follows:
  • Where the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects or
  • Where no subjects have been enrolled and no additional risks have been identified or
  • Where the remaining research activities are limited to data analysis of identifiable data.
• Continuing review of research where the convened 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

Note: The University no longer uses form K for modification/continuing review of studies. Please utilize the modification / continuing review function in PACS.

If all research-related interventions or interactions with human subjects have been completed and all data collection and analysis of identifiable private information described in the IRB-approved protocol has been finished, then the human subjects research study has been completed and the investigator should close the study.

The close out form formally closes the study in the PACS system, and serves as a final report to the IRB of study results, problems or significant events, and the status of research records and data.

Closure reports should be submitted to the IRB within 30 days of study conclusion.

Note: The University no longer uses form L to close out studies. Please utilize the study closeout function in PACS.