Revised Common Rule Information

Changes to Consent Forms

The revised regulations include new process requirements for the content, presentation, and organization of information so potential participants have all the information they need to make an informed decision whether to participate in a study. Under the revised regulations, informed consent forms must begin with a concise summary of the study activities, risks, and benefits for research participants. This change is intended to present information to potential participants that explains why someone might or might not want to participate. Additionally, consent forms must be concise and organized in a way that fosters comprehension.

Consent forms* will also need to include information regarding the potential for use of de-identified data and biospecimens. In other words, research collecting identifiable, private information and/or identifiable biospecimens must either:

• State that collected data/samples may be de-identified and used for future research or be given to another investigator for future research without additional informed consent OR
• State that collected data/samples will not be used for future research, even if de-identified.

*Updated informed consent templates are available on the IRB website.

 

Changes to the Exempt Categories

The revised regulations created new exempt categories and modified some existing categories. Exempt research is research involving no more than minimal risk and falls into specific categories identified in the federal regulations. Exempt does not always mean exempt from all of the requirements of the Common Rule; the activity must fit the description of the exempt category and not include nonexempt research activities. As per the Federal Office of Human Subjects Research Protections, investigators cannot self-determine whether her/his study fits the exempt categories. Exempt research must be determined by the IRB to satisfy specific criteria within each category for the research to be eligible for exemption. 

Continuing review is not required of exempt research; however, an exempt determination does not lessen an investigator’s ethical obligation to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. See below for more information on the new exemption categories:

Category (1) Research, conducted in established or commonly accepted educational settings.

• 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. For example, an investigator would need to prove that participating in an educational study would not interfere with student learning or adversely affect teacher assessment.

Category (2) Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) of adults.

• NEW: The scope will be expanded to include the collection of sensitive and identifiable data. However, the following is not allowed:

- Interventions (data collection only)

- The collection of biospecimens

• NEW: Three stand-alone (i.e., no interdependency) criteria exist to qualify for this exemption:

- Identifiers can’t be readily ascertained OR

- Disclosure of the data will not be harmful OR

- Participant identities can be ascertained but the study undergoes a limited review by the IRB. See below for more on limited IRB review.

NEW CATEGORY (3) Research involving benign behavioral interventions with adult subjects if the subjects prospectively agree to the intervention and information collection.

• 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.

- Allows the combination of certain interventions with data collection as described in #2 above.

• No deception is allowed.
• No children are allowed.

• NEW: Three stand-alone (i.e., no interdependency) criteria exist to qualify for this exemption:

- Identifiers can’t be readily ascertained OR

- Disclosure of the data will not be harmful OR

- Participant identities can be ascertained but the study undergoes a limited review by the IRB. See below for more on limited IRB review.

Category (4) Secondary research uses of identifiable private information or identifiable biospecimens

• Secondary research refers to re-using identifiable information and identifiable biospecimens that are collected for some other “primary” or “initial” activity.

-Refers to data generally found in some type of records (in the case of information) or some type of tissue repository (e.g., hospital’s department for storing clinical pathology specimens).

• NEW: allows for both retrospective and prospective data review—data are no longer required to be preexisting at the time an investigator begins a study.

Category (5) Research and demonstration projects that are conducted or supported by a Federal department or agency

• NEW: A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.

Category (6) Taste and food quality evaluation and consumer acceptance studies

• NO CHANGES

Continuing Review

With the Revised Common Rule, continuing review is not required for some minimal risk research, including exempt studies or those that undergo limited IRB review. 

For new studies determined to qualify for expedited review under the Revised Common Rule, the regulations now stipulate that continuing review is not required unless justified by the IRB. Therefore, most expedited studies will not require continuing review. Justifications for continuing review might include:

• The project is regulated by the Food and Drug Administration (FDA) or another sponsor that requires continuing review;
• The project involves additional regulatory oversight;
• Study procedures or risks indicate greater oversight is necessary; and/or
• Other research specific considerations (see “LIU Guidelines for Investigators” for more information).

Studies that undergo full board review are still required to undergo continuing review annually (unless specified differently by the IRB) unless the research has progressed to the point where only data analysis remains and/or the study is only accessing clinical data from procedures that subjects would undergo as part of standard clinical care.

Annual Check-In

Studies approved under the Revised Common Rule that are not subject to continuing review must complete a brief annual check-in form to update the IRB on the study status. The check-in form should take approximately five minutes to complete. The form should be completed in IRBManager.

Remember that even when continuing review is not required for a project, the Principal Investigator must adhere to the ethical principles of the responsible conduct of research.

Limited IRB Review