Common Rule Revisions - Effective January 21, 2019
The resources below were developed to help the Skidmore College human subjects research community understand the revisions to the Common Rule issued on January 19, 2017 and planned to take effect on January 21, 2019. Please check back often as updates will be made on an ongoing basis.
Overview of Common Rule Revisions
The Common Rule was updated in 2017 for the first time since it was issued in 1991. The revisions were set to take effect in 2018, but were amended twice to delay the date that regulated entities must comply with the revised version of the rule. These revisions are commonly referred to as the "revised Common Rule," the "Final Rule," or the "2018 Common Rule." The most significant changes that affect research institutions, Institutional Review Boards (IRBs), and investigators are provided below. Some Final Rule changes were made in an effort to clarify how the pre-2018 Common Rule is applied. The most significant revisions are intended to “modernize, strengthen, and make more effective” the current system of oversight. The revisions propose to better protect human subjects, expedite research, and reduce regulatory burden.
- The majority of changes will take effect January 21, 2019.
- The revised Common Rule applies only to new studies approved on or after January 21, 2019.
- Studies approved before January 21, 2019 must continue to comply with the previous Common Rule.
- Amendments to and continuing review of studies approved before January 21, 2019 will also be reviewed in accordance with the previous Common Rule.
Definitions
Most definitions remain the same; however, there are some important changes. Some important terms are undefined in the regulations, but are clarified in the Final Rule’s preamble. The most significant definition revisions are highlighted below:
Vulnerable: The term has been updated, but not defined in the Final Rule, to reflect that research subject vulnerability should be considered a function of the possibility of coercion or undue influence. IRBs should focus on vulnerability to coercion or undue influence in reference to the subject’s ability to make a decision to participate in research.
Human Subject: Rationale; the definition was revised to replace the reference to “data” with “information or biospecimens.” It also clarifies that an investigator is not conducting human subjects research by merely gathering information or biospecimens but instead when he/she “uses, studies, analyzes, or generates” identifiable private information or “identifiable biospecimens.”
- A living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Clinical Trial: This is a new term, as the pre-2018 rule did not include a definition.
- A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Research: The definition did not change; however, four categories of activities were removed from the definition to make clear that they are NOT within the Rule’s jurisdiction, as follows:
- Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) that focus directly on the specific individuals about whom information are collected
- Public health surveillance activities (collecting, analyzing, and using data to target public health and disease prevention)
- Authorized operational activities for national security missions
- Data collection and analysis that enables the conduct of certain activities carried out as part of the criminal justice system
Informed Consent Revisions
The final rule contains several major revisions to the requirements for informed consent. The changes are specifically intended to make informed consent more meaningful so that research subjects have the necessary information to make informed decisions, as follows:
Key Information in Consent Forms
New requirements relating to the content, organization, and presentation of information included in the consent form and process to facilitate a prospective subject’s decision about whether to participate in research. The informed consent documents/process must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This provision further requires that this beginning portion of the informed consent must be organized and presented in a way that facilitates comprehension.
This part of the informed consent must be organized and presented in a way that facilitates comprehension, and provide sufficient information that a “reasonable person” would want to have. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts.
Investigators remain responsible for providing more information to subjects when it is requested, making sure that subjects have sufficient time and opportunity to discuss the research, and to answer any questions subjects may have.
Currently there is no federal guidance defining exactly what “key information” is required in the concise and focused introduction. This is due in part to the fact that the application of this new requirement will depend upon the nature of the specific research study. The “key information” that a subject will need to decide whether to enroll in a Phase II Clinical Trial will be different from the “key information” needed to decide whether or not to enroll in a longitudinal or observational research study involving not greater than minimal risk.
The new rule does provide a brief description of five “factors” or “elements” that may encompass the “key information” that should appear at the beginning of an informed consent process and consent form:
1. A statement that the project is research and that participation is voluntary
2. A summary of the research, including...
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- Purpose of the research
- Duration, number of study visits
- Overview of study procedures
- Other study specific information
3. Reasonable, foreseeable risks or discomforts
4. Reasonable, expected benefits
5. Alternative procedures to course of treatment, if any (for studies involving an intervention or treatment)
The concise and focused introduction is meant to be brief, but the amount of information that should be included will depend on the nature of the research. For some minimal risk studies, the concise introduction may require only four or five paragraphs. For more complex research trials, up to two pages may be required. In general, the introduction should not be more than two pages.
It is important to note that the concise and focused introduction should include a summary of why an individual may want to participate, but should also include information about why an individual may not want to participate in the research, such as the fact that participation involves significant time commitments or risks. While the introductory section should not list every foreseeable risk of participation, it should describe those risks that occur with significant frequency or are of significant severity. Information provided in the concise summary should not be repeated in the main body of the consent document.
Elements of Informed Consent
Additional items have been added to the elements of informed consent. These new elements will need to be included in consent forms approved after January 21, 2019. The new language includes a basic element of consent that addresses the future use of identifiable private information or specimens. Three additional elements of consent have been added (when applicable) that relate to commercialization of biospecimens, return of results, and whole genome sequencing. [§46.116(b)(c)]
| When your project will involve... | Include in the Informed Consent: |
| The collection of identifiable private information or biospecimens |
A statement whether :
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| Use of biospecimens | A statement that the subject’s biospecimens (even if identifiers are removed)
|
| Clinically relevant research results |
A statement regarding whether the clinically relevant research results, including individual research results, will be disclosed to subjects, and if so under which conditions [46.116 (c)(8)] |
| Whole genome sequencing (i.e., sequencing of human germline or somatic specimen with the intent to generate the genome or exome sequence of the specimen) |
A statement indicating that the research will (if known) or might include whole genome
sequencing [46.116 (c)(9)] |
Waiver or alteration of informed consent
An additional criterion has been added that requires investigators to justify the use of identifiable private information or identifiable biospecimens. In addition to the existing requirements for a waiver the following information must be provided.
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- If the research involves using identifiable private information or biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format [§46.116(f)(2)(iii)]
A waiver of informed consent is no longer necessary for screening, recruitment, or determining eligibility. This is based on the IRBs determination that there are adequate privacy and confidentiality safeguards in place for the information obtained by investigators. This aligns with the HIPAA regulations. In order for the IRB to approve this, the procedures need to be listed as a part of the protocol and one of the following conditions must be met:
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- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
- The investigator will obtain identifiable private information or biospecimens by accessing records or stored identifiable biospecimens. [§46.116(g)]
Posting of Clinical Trial Consent Forms
Federally funded clinical trials must post a copy of the consent form on a “publicly available Federal Web site” (TBD) after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject. Currently there is no instruction from DHHS on the federal website to be used. The website will be updated as information becomes available.
Broad Consent
Under the current regulations, secondary research use of identifiable data/biospecimens is permissible through study-specific consent, by obtaining an IRB waiver of consent, or by removal of identifiers. In the Revised Common Rule, "Broad Consent" is an (optional) alternative consent process for use only for the storage, maintenance, and secondary use identifiable private information or biospecimens for future, yet-to-be-specified research. [§46.116(d)]
Skidmore College will not be adopting the use of Broad Consent on an institutional level as the tracking requirement may be burdensome. Exemption categories 7 and 8, which are specific to Broad Consent, will not be utilized. The issues of Broad Consent may be entertained in the future pending further guidance from OHRP.
Limited IRB Review
The new provision for limited IRB review allows certain research to be categories as exempt, even when the identifiable information might be sensitive or potentially harmful if disclosed. In order to qualify for exemption, the study must meet the standards of the limited IRB review. If the information is both identifiable and sensitive or potentially harmful, the safeguards offered by the limited IRB review may allow an exemption determination to be made.
Limited IRB review is required in the following circumstances:
- Exempt category 2 (educational tests, surveys, interview or observations of public behavior). When the information is recorded by the investigator in an identifiable manner and disclosure of the subject’s responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation.
- Exempt category 3 (benign behavioral interventions). When the information is recorded by the investigator in an identifiable manner and disclosure of the subject’s responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation.
When reviewing the exempt categories 2 and 3, the limited IRB review assures adequate protections for the privacy of subjects and adequate plans to maintain the confidentiality of the data.
Limited IRB review must be performed by the IRB Chair or by an experienced IRB member. The review can occur on an expedited basis and does not require consideration by a convened board. The reviewer may require modifications to the proposal prior to approval. Disapprovals must be made by the convened board. If the limited IRB review does not result in approval under the exempt categories, then the IRB can evaluate whether or not approval is appropriate under the expedited categories. Expedited research must meet all the approval criteria under 45 CFR 46.111, including either informed consent or waiver of consent.
Exempt Research Revisions
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 Skidmore researchers:
Exempt Criteria 45 CFR 46.104(d)(1)&˛Ô˛ú˛ő±č;–&˛Ô˛ú˛ő±č;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.
Exempt Criteria 45 CFR 46.104(d)(2)&˛Ô˛ú˛ő±č;–&˛Ô˛ú˛ő±č;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:
- 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;
- 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
- 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.).
Exempt Criteria 45 CFR 46.104(d)(3)&˛Ô˛ú˛ő±č;–&˛Ô˛ú˛ő±č;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:
- 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;
- 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
- 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).
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.
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.).
Exempt Criteria 45 CFR 46.104(d)(4)&˛Ô˛ú˛ő±č;–&˛Ô˛ú˛ő±č;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:
- The identifiable private information or identifiable biospecimens are publicly available;
- 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;
- 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
- 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.
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- 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 21, 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.).
Exempt Criteria 45 CFR 46.104(d)(5) &˛Ô˛ú˛ő±č;–&˛Ô˛ú˛ő±č;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.
Exempt Criteria 45 CFR 46.104(d)(6) –&˛Ô˛ú˛ő±č;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 AgricultureThis 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 decisionally-impaired persons could be allowed if their inclusion was justified.
Exemption7 - NOT CURRENTLY IMPLEMENTED AT SKIDMORE - 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).
Exemption 8&˛Ô˛ú˛ő±č;–&˛Ô˛ú˛ő±č;NOT CURRENTLY IMPLEMENTED AT SKIDMORE - 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.
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 Skidmore College); or
- 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.
If the IRB determines that these regulations can be applied, IRB approval will not expire and continuing review applications will no longer be required. However modifications and reportable events should still be submitted. Additionally, investigators must submit a Study Closure Form within 30 days of the termination of all research involving human subjects under the approved protocol.
If you have a currently active study that was approved prior to January 21, 2019, you should continue to operate under the old common rule regulations, and you will be contacted approximately two weeks before the study's expiration. At the time of your next continuing review, the IRB chair will determine if the new regulations can be applied. Your IRB approval letter will then include an expiration date or a notice that continuing review is no longer required.
Single IRB of Record
Most federally funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020. The IRB overseeing the research must be approved by the funding agency. Skidmore's plans for sIRB will be developed in the coming months.