What is the “Common Rule”?
The Common Rule is the Federal Policy for the Protection of Human Subjects.
Why is the Common Rule Important?
All Institutional and Community IRBs throughout the country must maintain policies that reflect guidance of the Common Rule. Everything we are responsible for as researchers – from how we recruit participants to how we respond when something goes wrong during a study – is guided by the Common Rule. The “New Common Rule” are the changes that went into effect January 21, 2019. The changes are intended to “modernize, strengthen, and make more effective” the current system of oversight under the Federal Policy for the Protection of Human Subjects that has been the federal Common Rule since 1991.
Where can I go if I need to find out about how my research will be the same or different, given the changes to the Common Rule?
The IRB Office within the Office of Sponsored Programs and Research Services. The IRB Office provides administrative support and guidance to the IRB Committee, and also makes determinations for all exempt-level studies submitted for IRB approval.
IRB Office Hours: Tuesdays 11 a.m. to 2 p.m.
If I received approval for my study prior to January 21, 2019, will I have to make any changes to my study for the New Common Rule?
No. Ongoing research studies that were initially approved by the IRB or determined to be exempt before the effective date will not be required to comply with the changes. All studies reviewed as exempt, expedited, or due for review at the first full board meeting following the compliance date (February 7, 2019) and thereafter must comply with the new requirements
What are the requirements under the New Common Rule for studies approved after January 21, 2019?
Changes to consent forms:
Informed Consent: In addition to the current procedures for informed consent, the following elements have been added and will be reviewed by the IRB:
- Informed consent must begin with a concise and focused presentation of key information that communicates directly to the participant why they are being asked to participate (or not) in the research (see attached sample consent/assent forms).
- For studies that involve collection of identifiable private information or identifiable biospecimens, investigators must include a broad consent statement:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after the removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant or legally authorized representative; or
- A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
- The additional elements may be applied for a review of consent forms, as appropriate:
- A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit; and
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to participants and if so, under what conditions.
Roosevelt will continue to document all reliance agreements with external IRBs.
This criterion has been redefined.
- The term “mentally disabled” has been replaced with “individuals with impaired decision-making capacity”
- The “handicapped” and “pregnant women” have been removed from all lists of vulnerable categories of subjects.
- All participants deemed vulnerable to coercion and undue influence comprises children, prisoners (RU includes parolees as part of this category), individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons.
New category for exempt studies: Limited IRB Review
- Limited IRB review allows certain research to be categorized as exempt, even when the identifiable information might be sensitive or potentially harmful if disclosed.
- Limited IRB studies include information that 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 is not allowed for research that must comply with the regulations of the Food and Drug Administration (FDA) or the federal Department of Justice (DOJ).
- Granting LIRB approval to a study simultaneously grants exempt status to the study.
- Continuing review is not required. PI’s with limited review studies in IRB Manager will receive a “check-in date” but are not required to submit any forms to the IRB.
- Researchers are responsible for consulting with the IRB office before making changes, to assess whether or not an Amendment application should be submitted through the IRB Manager system.
Exemption categories that qualify for Limited IRB Review
- Exemption category 2: The category applies to research that only includes interactions involving educational tests, surveys, interviews, and observation of public behavior. This category applies in the case that the information collected is recorded in a non-identifiable manner or disclosure of the participants’ responses outside the research would not reasonably place them at risk of criminal liability, be damaging to the person’s financial standing, employability, reputation and not be damaging to the participant’s educational advancement.
- Exemption category 3: This category applies to research involving benign behavioral interventions with adults who prospectively agree to the research, when the information collected is limited to verbal or written responses, including data entry or audiovisual recordings. Category 3 applies to behavioral interventions only, is not applicable to biomedical research, and applies only to adults.
- Exemption category 4: This category applies to secondary research use of identifiable private information or biospecimens. Research under this category no longer has to be in existence prior to the start of research. Changes to informed consent in relation to this category stipulate that the research can have broad consent from participants for use of their information or biospecimens once initially, with knowledge that the researcher may use their information for some unspecified time in the future without contacting them again. This category applies to secondary use of identifiable private information that is made publically available or recorded in a non-identifiable manner. Additionally, this applies to identifiable private health information (including information obtained from biospecimens). The data can also be collected by or on behalf of a federal agency or department for non-research purposes.
- Exemption category 7: This new exemption category covers storage or maintenance of identifiable private information or identifiable biospecimens for secondary research. Secondary research is defined as research with materials originally obtained for non-research purposes or for research other than the current research proposal. This exemption requires broad consent from the participants for the storage, maintenance, and secondary research use of their identifiable materials.
- Exemption category 8: This new exemption covers the secondary research use of identifiable private information or identifiable biospecimens and requires:
- 1) broad consent be obtained;
- 2) documentation or waiver of documentation of informed consent be obtained;
- 3) an IRB must conduct a limited review to make certain determinations relating to privacy and confidentiality protections and broad consent; and
- 4) investigators cannot include the return of individual research results to subjects in the study plan.
Does my exempt-level research require IRB Review?
Belmont Principles Apply: Although exempt research does not require IRB review, this research is not exempt from the ethical guidelines delineated in the Belmont Report. The IRB Office staff making the determination of exemption has the authority to require additional protections for subjects in keeping with the guidelines of the Belmont Report, even though the research falls within an exempt category.
Can a study that involves an intervention be considered for exemption?
No. Research that involves any type of intervention is not eligible for exemption and must be reviewed by the full board.
- Revised Common Rule (45 CFR 46) references to Limited IRB Review: .103(e); .104(d)(2)(iii); .104(d)(3)(i)(c); .109(a); .109(f)(1)(ii); .110(b)(1)(iii)
- Code of Federal Regulations, Title 45 – Public Welfare DHHS, Part 46 – Protection of Human Subjects
- The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, April 18, 1979