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Changes to the Common Rule
Effective January 21, 2019, the current federally-defined exemption categories for human subjects research will change, with:
- Modification to some existing categories
- Expansion in scope to several existing categories
- Addition of new categories
These changes reflect the recent trends in research oversight to reduce administrative burden on investigators and IRBs for minimal-risk research.
#1 - Educational Exemption
NEW: A new ineligibility criterion will be added to this interaction/intervention exemption for research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators.
Impact: Clarifies risk for education research.
#2 - Educational Tests, Surveys, Interviews, and Observation of Public Behavior
NEW: The scope will be expanded to include audio and video recording as well the collection of sensitive, identifiable data as long as a “limited review” is conducted by the IRB.
Impact: Allows for sensitive, identifiable data to receive an exempt determination.
#3 - Benign Behavioral Intervention
A "benign intervention" is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact. This does not include physical sensors or minimally invasive procedures. Data may also be sensitive and identifiable as long as a “limited review” is conducted by the IRB.
Deception will only be acceptable if the subject is told they will be unaware or misled about the nature or purpose of the research and they agree.
Impact: “Benign interventions” are currently reviewed as expedited review. With the Final Rule, this type of research will be permitted to receive an exempt review and he current federal exemption #3 will be eliminated.
#4 - Secondary Research (Identifiable Private Information/Biospecimens)
NEW: This category has been revised to also include biospecimens, as well as special carve-outs for HIPAA-covered data, federally conducted research, and federally generated data.
The revised Final Rule also removes the requirement that data must be pre-existing at the time that the investigator begins the research study. Note that this exemption does not cover any primary collection of information.
Impact: Provides greater clarity on what is allowable under this category.
#5 - Public Benefit/Service Program Research (Federal Demonstration Project)
NEW: The revision provides further clarification about what are “research and demonstration projects that are conducted or supported by a Federal department or agency.” To note, research that is reviewed under this category has always been quite rare.
Impact: Provides clarification on what is allowable under this category.
#7 & 8 - Storage and Secondary Use of Data/Biospecimens
NEW: These new categories cover the storage, maintenance and use of identifiable data and/or biospecimen repositories collected under broad consent as long as a “limited review” is conducted by the IRB.
Current Review Procedures
There are three levels of Institutional Review Board review:
- Full Board
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.
Current Review Categories
To qualify for exempt level review, the research study must fall into any of six (6) categories delineated in the federal regulations. Exempt DOES NOT mean the study is exempt from any review by the IRB--it means that the study does not require review by the full IRB.
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 level reviews are conducted by one IRB member. Under The College at Brockport's policy, The IRB office makes the final determination of exempt status.
Common examples of Exempt level research at The College at 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.
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (i) research on regular and special education instructional strategies, or (ii) 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: (i) the subjects are elected or appointed public officials or candidates for public office; or (ii) 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs
Classroom-based research done by faculty or students at The College at Brockport as part of the college curriculum is not under IRB purview (see Class Projects for more information). See CFR 46.101 on the OHRP website for more detailed information.
Expedited review is used to:
- Review some or all of the research that falls into the federally regulated categories
- Review minor changes in previously approved research
To qualify for expedited level review, new research must fall into any of nine (9) regulated categories delineated in the federal regulations. For research to be reviewed using the expedited review procedure, it must:
- Present no more than minimal risk to subjects and
- Involve only procedures listed in one or more of the expedited categories
Expedited level reviews are normally conducted by two or more qualified IRB members.
Common examples of research that may be reviewed at the Expedited level at The College at 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
Expedited research presents no more than minimal risk to subjects and involves procedures listed in one or more of the following federally designated categories. The list below includes only research typically done at The College at Brockport. The full list of all nine categories can be found at OHRP Expedited Review Categories.
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.
Note: 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.
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 (Full Board level review). Studies requiring Full Board review present more than minimal risk to subjects, and/or involve vulnerable populations.
Full Board studies are reviewed on a first come, first served basis by the IRB at scheduled meetings.
Common examples of research reviewed at the Full Board level at The College at Brockport are studies that include:
- Maximal exercise (VO2 Max) by healthy volunteers
- Institutionalized persons (e.g., prisoners, patients in long term care facilities)
- Sensitive topics (e.g., criminal behavior, sexuality)
Full Board studies research present more than minimal risk to subjects and involves procedures listed in one or more of the following categories. The list below includes only research typically done at The College at Brockport.
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 following flowcharts may also help you determine which category best fits your research:
- Chart 1: Is an Activity Research Involving Human Subjects?
- Chart 2: Is the Human Subjects Research Eligible for Exemption?
- Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?
- Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?
- Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?
- Chart 8: May the IRB Review Be Done by Expedited Procedures?