Common Rule Bulletin #2: Exemptions

NIH OFFICE OF HUMAN SUBJECTS RESEARCH PROTECTIONS (OHSRP) GUIDANCE ON THE RCR

Beginning January 21, 2019, all requests for exemption from IRB review must be submitted through the electronic IRB submission system (PROTECT) (https://protect.cc.nih.gov/PROD-IRB) and will be reviewed by IRB staff/members. These types of requests will now involve submission of either a protocol for prospective data collection (e.g. for educational research or tests, surveys, interviews, observation of public behavior or benign behavioral interventions) or a protocol for secondary research with biospecimens or data. Templates for these two types of protocols will be available soon on the new central IRB Office (IRBO) website, http://irbo.nih.gov/confluence/ under Templates Forms and Guidelines.

Only the IRB Office can make a determination that human subjects research is exempt from IRB review. Investigators are not permitted to make this determination. The determination that the research is exempt must be made before commencement of any research activities.

Please note that submission for determination of exemption for secondary research with biospecimens or data is only applicable to certain scenarios in which the investigator will be accessing identifiable biospecimens or data for his or her research, but not maintaining the identifiers. It does not apply to scenarios which solely involve the use of de-identified specimens or data. The latter scenario is referred to as "not human subjects research". While one may submit for a determination of "excluded from IRB review" for this type of research, it is no longer a requirement by NIH policy. The new iRIS system will include an application rather than a protocol to allow request for determinations of "not human subjects research".

Common Rule Bulletin# 2: Changes to the Exemption Categories

The revised Common Rule (rCR), referred to as the “2018 requirements” or sometimes as “the Final Rule”, contains several new provisions that take effect for all new research to reviewed on and after January 21, 2019. Note: This guidance is intended for use by the NIH Intramural Research Program (IRP) and may be superseded by future NIH guidance or policy, or guidance issued by the Office for Human Research Protections (OHRP).

Summary of the Changes that Might Affect NIH Research

Exemption 1 applies to research in established or commonly accepted educational settings that involves certain normal educational practices, such as research on instructional techniques already in use or classroom management. The 2018 revisions to the Common Rule have added a new restriction to the applicability of Exemption 1: the research must also not be likely to adversely impact the student’s opportunity to learn required educational content or the assessment of educators who provide the instruction. Commentary provided by the Secretary’s Advisory Committee on Human Research Protections (SACHRP) on this exemption category can be found here: https://www.hhs.gov/ohrp/sachrpcommittee/recommendations/attachment-b-november-13-2018/index.html.
Exemption 2 applies to research involving educational tests, surveys interviews or observation of public behavior. It is important to note that the restrictions from conducting research with children, under this exemption category, have not changed in the rCR. Specifically, this category does not apply to survey or interview research with children or research involving public observation with children, when the researcher participates in the activities being observed. SACHRP has also provided some interpretive guidance relevant to this exemption category (https://www.hhs.gov/ohrp/sachrpcommittee/recommendations/attachment-b-november-13-2018/index.html).
- Part of the criteria is the same as before:
  - (1) the data being collected as a part of the study and recorded cannot be readily linked back to the subjects, directly or through identifiers linked to the subjects; or
  - (2) any disclosure of the data would not place the subjects at risk of certain harms
- The following address two notable changes to Exemption 2 in the rCR.
  - First, the word “only” has been added to clarify that Exemption 2 applies to research that “only includes interactions” involving educational tests, surveys, interviews, and observation of public behavior. For example, this category is not applicable to research involving interventions. This clarification is consistent with OHRP’s understanding of Exemption 2 in the pre-2018 rule but was added to remove any ambiguity.
  - The other change is that now more research can qualify for Exemption 2 than under the pre-2018 Common Rule, e.g. when sensitive, identifiable data is being collected. In this case, the submission must include a section which explains how the investigator intends to protect the privacy and confidentiality of the subjects. Then the IRB can conduct a limited review of the research to determine if there are adequate privacy and confidentiality protections in the study. If this is confirmed, the project can qualify for an exemption.
Exemption 3 has been completely revised to address a different category of research than before. This is an entirely new exemption category and as of yet, no formal guidance has been issued by OHRP. However SACHRP, commented on the types of activities that might meet this category and their interpretation of some of the requirements in a letter issued in July 2017 (https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-baugust-2-2017.html). The new Exemption 3 applies to research involving benign behavioral interventions. (It is not applicable to biomedical research.) This category only applies to research with adults. The adults must also prospectively agree to the research. For research to qualify under exemption 3, the data collection must be limited to verbal or written responses, including. data entry or audiovisual recordings.
- The essential points regarding this exemption category are as follows:
The characterization of a benign behavioral intervention under the rCR is as follows: a benign behavioral intervention must be brief in duration (although data collection may take longer). Also, the intervention must be harmless, painless, and not physically invasive. Further, the intervention must not be likely to have a significant adverse lasting impact on subjects. The investigator must have no reason to believe that the intervention will be offensive or embarrassing to subjects, and should take into consideration the subjects’ population, the context of the research, the topic, and other characteristics of the study.
- The criteria for when Exemption 3 applies to such research is the same as for Exemption 2:
  - (1) the data being collected as a part of the study and recorded cannot be readily linked back to the subjects, directly or through identifiers linked to the subjects; or
  - (2) any disclosure of the data would not place the subjects at risk of certain harms; or
  - (3) the data is recorded in an identifiable manner, even if sensitive, but the IRB conducts a limited review and determines that there are adequate privacy and confidentiality protections in the study. In other words, if the research involves sensitive, identifiable data, the submission must include a section that explains how the investigator intends to protect the privacy and confidentiality of the subjects.
Exemption 4 applies to the secondary research use of identifiable data or identifiable biospecimens. In the pre-2018 Common Rule, there are two provisions for when Exemption 4 can be used: (1) when the identifiable materials are publicly available, or (2) when the data is recorded by the investigator in a de-identified manner. For example, the researcher conducts a retrospective medical chart review and records the necessary data in a data sheet for future analysis but does not record any personal identifiers.
- New provisions have been added to Exemption 4 so that more research can be exempt.
  - The rCR adds the following new provision that might apply to some NIH research: when the secondary research is conducted by or on behalf of a federal department or agency, using data collected or generated by the government for non-research purposes, e.g. QI/QA data. In this case, the data would also have to meet federal privacy standards (e.g. be covered under the Privacy Act). It's important to note that the use of data that was collected under NIH protocols including clinical data would not qualify for this exemption.
  - One other change under this exemption is that the data and biospecimens no longer have to be in existence prior to the start of the research to qualify. For example, a research study that proposes to analyze specimens or data that will be collected for clinical purposes in the future might qualify for this exemption.
  - Another change is that if an investigator receives this exemption based on a plan to record data about individuals in a de-identified manner, he or she must not attempt to reidentify or contact the research subjects.
- Exemption 5 applies to research involving public benefit or service programs while Exemption 6 applies to research involving taste and food quality evaluation and consumer acceptance studies. Because neither of these exemptions historically have been used at the NIH, we will not provide additional detail about them at this time.
- Exemption 7 involves the storage or maintenance of identifiable data or biospecimens for secondary research. Exemption 8 involves secondary research with identifiable data or specimens. Both exemptions require that the researcher has previously obtained "broad consent" from the original research subjects. Broad consent under the rCR involves a very specific and detailed set of elements that most current consent language about future research do not contain. NIH has not yet decided to implement broad consent per the rCR. Therefore, these two exemptions are not applicable for research being conduct by NIH researchers.