Revised Common Rule

KEY CHANGES HAVE BEEN IMPLEMENTED
AS OF 
JANUARY 21, 2019
PER THE REVISED FEDERAL REGULATIONS

The federal government has made extensive revisions to the federal regulations that govern all human subjects research, otherwise known as the common rule. Many of these regulations are set to take effect on January 21, 2019, meaning all applications approved* by the IRB after January 21, 2019 will be subject to these new regulations. 

Note that all applications approved* prior to January 21, 2019 are still subject to the old rules and must abide by these. 

*Please note: This is not a submission deadline, but an approval deadline. Any research submitted prior to January 21, 2019 but not approved until after January 20, 2019 are subject to the new regulations.  

Applications approved prior to January 21, 2019, while subject to the old rules at time of approval, may be transitioned to the new rules at a future time at the discretion of the IRB.

Expand All / Collapse All

Revised and New Definitions

Benign Behavioral Intervention: Interventions that 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

Human Subject: A living individual about whom an investigator conducting research:

  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens

                    —or—

  1. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

Intervention: Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes

Limited Review: A subcategory of Exempt status for which an exempt protocol and application may be submitted, but the application will be reviewed by one or more members of the IRB 

Vulnerable Population: Subjects vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons

Additional Activities Deemed Not to be Research

Scholarly and journalistic activities, including the collection and use of information, that focus directly on the specific individual about whom the information is collected.

Examples include but are not limited to:

  • Oral History
  • Journalism
  • Biography
  • Literary Criticism
  • Legal Research
  • Historical Scholarship

Please note the following OHRP Guidelines regarding this category of non-human subjects research:

Although activities described in [this] category may sometimes be performed in such academic fields as anthropology or sociology, a significant portion of the activities that are characteristic of these fields fall outside of [this] category and therefore remain within the scope of [the regulations]. Studies using methods such as participant observation and ethnographic studies, in which investigators gather information from individuals in order to understand the beliefs, customs, and practices, not only of those individuals, but also of the community or group to which they belong, would not meet [this] category. The purpose and design of such studies or activities is to reveal something about the community or group – that is, to develop generalizable knowledge.  Because the purpose of such studies or activities is not to limit the inquiry to knowledge about the particular individuals being observed, the protections provided by the requirements of [the regulations], such as the requirement to minimize any harm to the specific individuals from which the information was collected, are appropriate. Such activities would continue to fall within the scope of the definition of "research" under the 2018 Requirements.

Revised Exempt Categories

See the Revised Exempt Categories sheet for a list of the new and changed exempt categories.

More specifically, note the following changes:

Exempt Category #1: This exemption now includes the caveat that there must be no negative impact on a subject’s opportunity to learn required content or the assessment of the educational instructors. 

Exempt Category #2: This exemption is now explicitly limited to research involving interactions (verbal and written responses only – no interventions). 

In addition, identifiable private information may be recorded (even if sensitive) with the provision that a limited IRB review is conducted. 

Exempt Category #3: This is a completely new exempt category - see list of revised exempt categories for the full description.

This new exemption 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.

Exempt Category #4: This exemption has replaced the term Existing Data with the concept of Secondary Research. Data under this category is no longer required to exist at the time of IRB submission – data may be both retrospective and prospective. 

Exempt Category #5: This exemption has been updated to allow projects that are not only conducted by a federal agency, but are simply funded by a federal agency and includes projects that not only study/evaluate a program, but also improve the program being studied. 

Exempt Caategory #6: No changes have been made to this exemption.

Revised Categories of Vulnerable Populations
  • Children
  • Prisoners
  • Individuals with impaired decision-making capacity
  • Economically disadvantaged persons
  • Educationally disadvantaged persons
Research Involving Prisoners

Research that only incidentally includes prisoners is no longer considered “Research with Prisoners” and now qualifies for exempt and expedited review.

Note that research that focuses on or actively recruits prisoners will still need to be reviewed by the full committee with a prisoner representative present. 

Informed Consent

Additional elements of informed consent will be required. For an updated list of elements, see the Revised Elements of Informed Consent.

Note that the general elements of informed consent now include the future use of data, where the investigator must explain that data may be de-identified and retained for additional or subsequent research (or, if not applicable, that the data collected will not be distributed for future research, even with the identifiers removed).

While e-signatures will now be permissible, it should be noted that this is not simply a matter of the subject typing his/her name - the electronic system must include a method to ensure that the person electronically signing is the subject or LAR him/herself. If verification is not possible, a waiver of documented consent must be requested.

In addition, the revised regulations require that consent forms begin with a concise and focused presentation of the key information (organized and presented in a way that facilitates comprehension) 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. Consent forms that are inherently short (approximately three or fewer pages) will generally be considered to comply with this requirement. 

An additional category of research eligible for a waiver of documented informed consent

A waiver of documented informed consent may be requested if 1) the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, 2) the research presents no more than minimal risk of harm to subjects, and 3) there is an appropriate alternative mechanism for documenting that informed consent was obtained. 

An additional criterion for a waiver of or alteration to informed consent

In order to qualify for a waiver or alteration to informed consent, the research may only involve using identifiable private information or identifiable biospecimens if the research could not practicably be carried out without using such information or biospecimens in an identifiable format. 

Grant Congruency

Federal regulations no longer require grant applications to be reviewed with the IRB protocol to ensure congruency. 

Note that grant congruency may still be required by some funding agencies, however.

Continuing Review

Formal continuing review will be eliminated for studies reviewed via expedited review. 

Note that the IRB may require continuing review for some studies, if the reviewer feels there is cause. 

Note, as well, that modifications and final reports continue to be required for all research, regardless of review category.  

Review of Exempt Research
Brandeis University will continue to follow OHRP's recommendation that exempt determinations be made by someone other than the investigator. For Brandeis, exempt determinations will continue to be made within the HRPP office.