The new common rule does not mean that you do not have to submit your research involving human subjects to the IRB. Kenyon's policy is still to review all possibly "Human Subjects Research" to determine if it is "Human Subjects Research", if it qualifies for an exemption from a higher level review, or if it needs a limited or full board review.
The new Common Rule or "final rule" originally published on January 19, 2017, makes a number of revisions to the Federal Policy for the Protection of Human Subjects. The revised policy is described here as the “2018 Requirements.” The 2018 Requirements were originally scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision).
Now, an interim final rule delays the effective date and general compliance date of the 2018 Requirements to January 20, 2019.
Until January 20, 2019, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf .
This means that before January 20, 2019, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule. An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at §__.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.
For Kenyon, this means that any research with federal funding submitted to the IRB prior to 1/20/2019 will be reviewed with pre-2018 rules. All other research will be reviewed with the 2018 rules unless there is an obvious conflict. One of the main advantages of the 2018 rules, is the expanded list of exemptions from additional review.
|Type of Document||Document File||Document Description||Version Date|
|Individual Application||Individual Application Form
*Do Not reformat
|For an Individual Kenyon Researcher's application for IRB Review||1/20/2019|
|Simplified informed consent template. Consider using for surveys, interviews, focus groups. (Minimal Risk) YOU MUST EDIT this form||1/20/2019|