1. Upcoming Changes to the Common Rule
Presentation to the SPARC meeting
UNC General Administration By
Deb Paxton
North Carolina State University

2. Changes to the Common Rule
Common rule is the standard for human subjects protections
14 federal agencies have signed on to the common rule and therefore follow the common rule
All DHHS
Department of Commerce
NSF
Consumer Product Safety Commission VA
USAID
DOD
Department of Housing and Urban Development
NIJ
Department of Education
Department of Agriculture
Department of Transportation
Department of Energy
NASA
Changes recently published with an implementation date of January 19, 2018 (longer for cooperative studies)

3. Changes to the Common Rule
Broad changes to:
Scope
IRB operations
Informed consent
Exemptions
(see handout from PRIM&R)

4. Changes to scope Definition of research Definition of human subject
Definition of clinical trial
“….one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”
Identifiable data/specimens – definition of “identifiable” to be regularly revisited and revised if necessary
Definitions of vulnerable populations
pregnant women and people with physical disabilities are no longer listed as vulnerable to coercion or undue influence
Inclusion of tribal law when appropriate

5. Changes to IRB operations
sIRB
Formalization of reliance agreements
“Checking the box” is no longer an option
institutions will need to codify the application of human subjects protections to non-human subjects research
Continuing review of research is not required for:
research that received expedited review
research that was reviewed under “limited” IRB review
research that have completed data collection and are now only analyzing data or accessing follow up clinical data from regular clinic visits

6. Changes to informed consent
New language to clarify PI responsibilities regarding informed consent
New elements
specific language about collection of identifiable data/specimens
biospecimens
genomes
Broad consent for data/specimen repositories
Recruitment/screening waivers
Electronic signatures accepted
Consent forms for clinical trials posted online
Legally authorized representatives

7. Exemptions Wording changes “readily ascertained”
clarification of application of exempt criteria to subparts B, C, and D
Addition of “benign behavioral interventions”
exemption of intervention is not allowed if deception is involved unless prospective agreement to deception has been obtained
Limited IRB review
opens exemption categories to non-anonymous, non-harmless research if it undergoes “limited IRB review”
Exemption of secondary use of existing, identifiable data/specimens
“Broad” consent referenced and reviewed

8. Limited IRB Review
In order to approve a project under “limited review,” the IRB does not need to find the traditional criteria for IRB approval, but instead must determine:
Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is appropriately obtained
NOTE THERE IS NOT AN OPTION FOR A WAIVER HERE
Broad consent is appropriately documented or waiver of documentation is appropriate
If a change is made for research purposes to the way identifiable private data/specimens are maintained, there must be adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
Additional protections for subjects culnerable to coercion or undue influence remain in place.

9. Broad Consent
Broad consent is for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. 
Information to be included in Broad consent:
A description of any reasonably foreseeable risks or discomforts to the subject;
A description of any benefits to the subject or to others that may reasonably be expected from the research;
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
When appropriate
A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

10. Broad Consent, Continued
A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens.
A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained, and for which they may be used for research
“indefinitely” is an option
Unless details about specific research studies are provided, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject
An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.