NPRM-2015-Significant Change #3: Activities excluded from IRB review

Significant change to the Common Rule proposed in the NPRM: Activities excluded from IRB review

After years of debate and speculation, sixteen federal agencies have collaborated on a notice of proposed rulemaking (NPRM) with the stated purpose of modernizing, strengthening, and making more effective the federal policy for the protection of human subjects. While the NPRM does not tackle as many issues as the Advanced Notice of Proposed Rulemaking (ANPRM) of July 2011, it nevertheless proposes a number of bold moves to streamline the clinical trial process. The U.S. Department of Health and Human Services has identified eight of the proposed changes as “most significant.” The following is the third of these significant changes and a brief description prepared by Quorum Review’s regulatory attorneys:

Change proposed in the NPRM

Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.

Quorum’s description of the proposed change

The NRPM creates a new section of regulations that would exclude certain activities from the requirements of the Common Rule. This proposal should provide clarity around the application of the rule for activities that have historically fallen in a “gray area”. The drafters hope to eliminate inappropriate application of the rule with a focus on the risks to individuals relative to the public benefit provided by a given activity. An exclusion would not require a third party review or assessment to justify its status.

The categories of “excluded” activities are described further in the table below. Note that some of these excluded activities currently appear as exemptions under the current Common Rule.

Excluded activities proposed in the NPRM

Activities deemed “not research”

Institutional activities that do not clearly meet the definition of research

The first three excluded categories of activities are intended to clarify applicability of the Common Rule where there has historically been ambiguity. These categories include:

  • program improvement[1];
  • oral history, journalism, biography, and historical scholarship[2];
  • criminal justice[3].

The program improvement and criminal justice categories are limited to data collection and analysis. This exclusion would allow institutions to engage in the described activities in order to operate and improve operations without being subject to the restrictions of the common rule. Likewise, the oral history, journalism, biography, and historical scholarship activities are thought to be impeded by the restrictions in the common rule. The drafters indicate the codes of ethics governing these fields as well as the purpose of these types of activities (focusing on specified individuals) makes the application of the Common Rule inappropriate.

Activities that have non-research purposes

The second three excluded categories of activities are thought to serve the public welfare and are unnecessarily hindered by the application of the common rule. They include:

  • quality assurance and quality improvement[4];
  • public health surveillance[5];
  • intelligence surveillance[6].

The proposal recognizes that the application of the common rule to QA and QI activities may have a chilling effect on innovation and the improvement of care. This exclusion applies only to the implementation of practices that are already accepted with a goal of improving delivery or quality of treatments or services.

The two surveillance categories apply to activities conducted by public health authorities or by defense, national security, or homeland security authorities for specified purposes. The activities excluded are required by law and helps the respective authorities to fulfill their missions to protect public health or national security. Furthermore, these activities are conducted for non-research purposes though they may appear to be research in some aspects. Given the other protections in place and the public benefit of the activities the application of the common rule is thought to be inappropriate.

Activities that are low-risk and already subject to independent controls

The next four excluded categories are activities that are considered research; however they are either inherently low-risk or there are appropriate protections in place to mitigate risk. Imposing the common rule is burdensome and would offer little additional protection to subjects. These categories include:

  • educational test, survey procedures, interview procedures, or observation of public behaviors[7];
  • research involving collection or study of information that has or will be collected[8];
  • research conducted by a government agency using government-generated or government-collected data[9];
  • activities regulated by HIPAA[10]

Read all the changes

Click here to read all of the significant changes to the Common Rule proposed in the NPRM.

References

[1] NPRM at §__.101(b)(1)(i)
[2] NPRM at §­__ .101(b)(1(ii)
[3] NPRM at §__ .101(b)(1)(iii)
[4] NPRM at §­­__.101(b)(1)(iv)
[5] NPRM at §­__.101(b)(1)(v)
[6] NPRM at §__.101(b)(1)(vi)
[7] NPRM at §­__.101(b)(2)(i)
[8] NPRM at §__.101(b)(2)(ii)
[9] NPRM at §__.101(b)(2)(iii)
[10] NPRM at §__.101(b)(2)(iv)

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