Summary of Changes to The Common Rule

Applicability

45 CFR 46.101

Definitions

45 CFR 46.102

46.102(e)-Definition of Human Subjects includes identifiable biospecimens.

46.102(I)-Examples of what are not considered human subjects research.

46.102(m)-Defines written (or, in writing) as paper or electronic format.

Assurance

45 CRF 46.103

Exempt Research

45 CFR 46.014

Exempt categories 1-2 and 5 are further defined, and 6 remains unchanged

1: Normal educational practices not likely to adversely impact students' opportunity to learn.

2:Criteria iii specifies that an IRB can conduct a limited review for studies in which identifiable information is obtained/recorded,

3:Research involving benign behavioral interventions with adult subjects,in conjunction with the collection (verbal, written, data entry, audio/visual recording) of information is permitted with prospective consent and at least one of three additional criteria are met.

4:Secondary research  for which consent is not required is permitted if at least one of three additional criteria are met.

5:New section for research conducted by federal employees. New categories are 3-4 and 7-8.

7:Store/maintain identifiable private information /specimens for potential secondary research permitted by a limited IRB review.

8:Research involving the use of identifiable private information/specimen for secondary research use for which broad consent is required, is permitted when 3 additional criteria are met.

IRB Review of Research

45 CFR 46.109

46.109(a) - Exempt Research that require limited IRB review as a condition of exemption.  Limited IRB Review is performed at an IRB Expedited Subcommittee meeting by an IRB Chair or an IRB Chair-designee.

Criteria for IRB Approval

45 CFR 46.111

46.111(a)(3) & 46.111(b) - Vulnerable populations:Pregnant women and handicapped/mentally disabled populations are no longer considered vulnerable. Individuals with impaired decision-making capacity and economically/educational disadvantaged are considered vulnerable population.

46.111(a)(7)(i) - Include adequate provisions to protect privacy of subjects / maintain confidentiality of data. DHHS guidance forthcoming.

46.11(a)(8)  Approval criteria for a limited IRB review 

Cooperative Research

45 CFR 46.116

This entire section has been revised.  A brief summary is outlined below:

46.116(a) - New requirement of Key Information at the beginning of the consent form.

46.116(b) - One (1) new Basic element of informed consent.

46.116(c) - Three (3) new Additional elements of informed consent.

46.116(d) - Seven (7) elements of a Broad consent form.

46.116(f) - Revised criteria for a General Waiver or Alteration of Consent.

46.116(g) - New exception to Informed Consent: Screening, recruiting, determining eligibility is permitted under specific circumstances.

46.117(a) - Includes electronic format.

46.117(b) - Ensures that Key Information was presented first to the subject.