The regulations have provided new categories and clarification to existing categories of exempt research studies. See our exemptions page for the list of complete categories. Some exemptions may now require limited IRB review, which is similar to expedited review.
New Exempt Categories:
• Category 3: Includes review of research containing benign behavioral interventions. These are defined as being brief in duration, harmless, painless, not physically invasive, not likely to have significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. • Categories 7 & 8: Each of these categories related to secondary analyses where the researcher is using identifiable private information or biospecimens for which Broad Consent is required. The Tufts SBER IRB will not be implementing these new categories.
Updates to Existing Categories:
• Category 1: Research cannot be exempt under category when if the research has any negative effects on students’ learning or the assessment of the teachers. • Category 2: Research using surveys, interviews, or educational tests with adult participants will now allow for the collection of sensitive information if, during limited IRB review, the IRB determines that adequate provisions are in place for protecting the privacy and confidentiality of participants. • Category 4: Whereas prior to the new regulations, all secondary data had to be “on the shelf” the new regulation allows for the secondary analysis of prospective data.
At the Tufts SBER IRB, all new applications for human subjects research should be submitted on the new protocol template. The Tufts SBER IRB will make a determination about whether a study is exempt, or whether limited IRB review or committee review is necessary.
The regulations require a new "Key Elements" section to be added to the top of each consent document. This new section should provide a brief overview of the research such that a reasonable person would be able to decide whether to participate. The regulations also include new requirements for consent. These new requirements and the rearrangement of content is expected to facilitate a potential subject's decision to participate or not. A new consent template is available on our website.
Key Elements should include: • A statement that the project is research and participation is voluntary; • A summary of the research including the purpose, duration, and brief list of procedures; • Reasonable, foreseeable risks or discomforts; • Reasonable, expected benefits; • And alternative procedures of courses of treatment, if any.
At the Tufts SBER IRB, the Key Information section is only required for informed consent documents 4 pages or more in length.
Consent forms must now also contain one of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such 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 subject or the legally authorized representative, if this might be a possibility; or • A statement that the subject’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 regulations have also added a number of required elements for informed consent forms, when applicable: • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
The regulations no longer require continuing review for some minimal risk studies. However, Tufts is still required to monitor research being conducted at the University. To meet this requirement, the SBER IRB will require an annual administrative check-in. This new check-in procedure will be used on the following studies:
• Studies approved using expedited procedures (categories 1-7). • Studies that are no longer enrolling subjects and are in the analysis phase only.
Reportable new information (including adverse events or unanticipated problems) must still be promptly reported to the IRB.
The current continuing review process will still be required for all studies approved prior to January 21, 2019.
IRB reliance agreements allow two or more institutions to cede review to a single IRB for oversight of a collaborative or multi-site research study. This helps streamline the review process and reduce researcher and administrative burden. All NIH funded studies are required to use a single IRB of record. This rule went in to effect January 25, 2018. The same rule will go into effect for all US based federally funded research on January 20, 2020.
Tufts University and over 500 other institutions use the SMART IRB online reliance system to put agreements into place. Click here for more information about SMART IRB, participating institutions, and the reliance request process. To request a reliance agreement with an institution that does not participate in SMART IRB, submit a Reliance Agreement Request Form.