Common Rule Revisions

The resources below were developed to help the Ohio State human subjects research community understand the revisions to the Common Rule issued on January 19, 2017 and planned to take effect on July 19, 2018. Please check back often as updates will be made on an ongoing basis.

Exempt Research Revisions

Exemption 1 – Modified

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices, so long as the research is not likely to adversely affect students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

Exemption 2 – 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).

Exemption 3 – New

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject.  Benign behavioral interventions are defined as being 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.  The IRB must conduct a limited IRB review to determine that there are adequate provisions for protecting privacy and maintaining confidentiality.  Examples:  subjects play an online game, solve puzzles under various noise conditions, or decide how to allocate a nominal amount of received cash between themselves and someone else.

Includes authorized deception.

Exemption 4 – Modified

Secondary research use of identifiable private information and identifiable biospecimens for which consent is not required, when:

• The identifiable private information or identifiable biospecimens are publicly available;
• The information is recorded by the investigator in such a way that the identity of subjects cannot readily be ascertained, and the investigator does not contact subjects or try to re-identify subjects;
• The secondary research activity is regulated under HIPAA;
• The secondary research activity is conducted by or on behalf of a federal entity and involves the use of federally generated non-research information provided that the original collection was subject to specific federal privacy protections and continues to be protected.

The goal of the exemption is to facilitate secondary research using identifiable private information or identifiable biospecimens that have been or will be collected or generated for nonresearch purposes or from research studies other than the proposed research study.

Exemption 5 – Modified

Public benefit and service programs and research and demonstration projects conducted or supported by a federal department or agency.

Exemption 6 – Unchanged

Exemption 7 – New

The storing and maintaining identifiable private information or identifiable biospecimens for secondary research use.  Requires that an IRB conduct limited IRB review to make the following determinations:

• Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained;
• Broad consent is appropriately documented or waiver of documentation is appropriate, and
• If a change is made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, adequate provisions must be in place to protect the privacy of subjects and to maintain the confidentiality of data.

Exemption 8 – New

Applies to the secondary research use of identifiable private information and identifiable biospecimens for specific secondary research studies. Secondary research under this exemption would generally be conducted with the information or biospecimens stored and maintained under the exemption 7.  Requires:

• Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens, and
• Documentation of informed consent or waiver of documentation of consent was obtained
• An IRB conducts a limited IRB review to make the determination, and to make the determination that the research to be conducted is within the scope of the broad consent; and
• The investigator does not include returning individual research results to subjects as part of the study plan. However, it is permissible under this exemption to return individual research results when required by law regardless of whether or not such return is described in the study plan.
• This exemption could also apply if the investigator obtains appropriate broad consent from the subject in addition to the consent to an original specific study, and then proceeds to use the information or biospecimen in a secondary study.