经修订的通用规则

The federal policies mandating the protection of human subjects are known as the “Common Rule,1月21日, 2019, a substantial revision to the Common Rule went into effect. These changes are meant to ease some researcher burden while enhancing the protection of human subjects. These changes apply only to new studies submitted on or after January 21, 2019. Please note: the revised Common Rule does NOT apply to FDA-regulated and Department of Justice studies.

花旗集团的培训 & 经修订的通用规则

The CITI Program has updated their current modules to reflect the changes to the Common Rule, which will not affect the module assignments 要求 by CSUF IRB. Next time you are due for training, you will see the latest content.

研究定义的变化

The revised common rule contains a more detailed definition of "research", specifically pointing out certain areas that are NOT "research". 所以什么不是研究?

  • Scholarly and journalistic activities focused directly on the specific individuals about whom the information is collected (i.e.，口述历史).
  • 进行公众健康监察, 支持, 要求, 命令, 要求, or authorized by a public health authority.
  • Collection and analysis of information or biospecimens for a criminal justice agency authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized activities in support of intelligence, 国土安全, defense or other national security interests.

加快审查

  • Changes: No continuing review 要求 of expedited research unless the IRB documents a rationale for requiring it.
  • Summary of Expedited Categories (unchanged).

知情同意变更

There are some changes to the process of informed consent. These changes are highlighted on the CSUF informed consent templates. 这些包括:

Informed consent must specifically give prospective participants the information that a reasonable person would want to have in order to make an informed decision about whether to participate. 使用这个标准, informed consent remains focused on what information a reasonable person would want to have to make an informed choice about participation.

An additional change is that the information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, 也可能不会, want to participate in the proposed research.

The informed consent needs to include a notice about whether participants' information or biospecimens collected as part of the current research might be stripped of identifiers and used for other research in the future. The purpose of this is to increase transparency by letting participants know that it might happen.

现有的协议

Protocols approved under the current regulations will be allowed to continue if no modifications are needed. We may look at these on a case by case basis to transition them to the revised regulations if there is any benefit.

续签

Under the revised Common Rule, continuing review/renewal is not 要求 for:

  • Research that is eligible for expedited review (unless the IRB documents a need for continuing review).
  • Exempt research conditioned on limited IRB review.
  • Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable- this includes Full Review applications.
  • Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

重要的是, the IRB can override this default and still choose to require continuing review, as long as the IRB documents the decision and the rationale for this decision.

对于CSUF, this means that research classified and approved as exempt (limited IRB review) and expedited will no longer need to be renewed on an annual basis. The initial approval will suffice for the duration of the research unless there is a change to the research (modification/amendment).