Levels of Review
The review procedure is based on the category of your research. Review the following guidelines to determine the correct category for your proposal. The researcher—and if appropriate, the faculty advisor—makes the initial category determination. The IRB makes the final decision.
The researcher can always request a higher level of review than what is required.
- Full Board
- Outside Determination
- Limited IRB Review
- Continuing Review / Modification
To qualify for exempt level review, the research study must fall into any of six 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.
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.
Classroom-based research done by faculty or students at SUNY Brockport as part of the university curriculum is not under IRB purview (see Class Projects for more information). See CFR 46.101 on the OHRP website for more detailed information.
#1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular and special education instructional strategies, or
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
#2 (a). Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement)
#2 (b). Research involving the use of surveys, interviews, or observation of public behavior unless information is recorded with identifiers linked to subjects and subjects’ responses could place subjects at risk (e.g., criminal or civil liability, financial standing, employability or reputation).
#3. Research involving educational tests, surveys, interviews, or observation of public behavior is exempt if:
- The subjects are elected or appointed public officials or candidates for public office; or
- A specific federal statute requires confidentiality of identifiable information to be maintained throughout the research and permanently thereafter.
- #4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
#5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs
- 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.
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 two 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
- 4. Collection of data through noninvasive procedures, such as physical sensors applied to the surface of the body or moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7 (a). 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)
7 (b). Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- 8. Continuing review of research previously approved by the convened IRB as follows: 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 where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.
- 9. Continuing review of research that does not fit into the above categories but where 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.
FULL BOARD REVIEW
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 located here.
- 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
LIMITED IRB 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 University’s IRB will still require continuing review for all categories of research. 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.
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.
All modifications submitted should include the original approved IRB documents, with changes highlighted, and the new documents reflecting all proposed changes.
Student projects now have a review date of four months. This means that the IRB will check in with any student PIs approximately three months after their study approval date. At that point, student PIs must submit a continuation form (Form K) or a continuation through PACS to keep working on their studies or a close-out form (Form L) that serves as a final report for the IRB.
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. Students projects may receive more than two continuations depending on the project’s timeline.
Continuations for proposals in all categories of research (exempt, expedited and full board) should be requested using Form K or through PACS.
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
SPECIAL POPULATION REQUIREMENTS
For more information on requirements for special populations and which populations fall under the special populations category, view our webpage below.