Please pass on to interested researchers and others. All are welcome.
Greetings from the CPHS Office,
Please note that our first forum is tomorrow (Tuesday) at 5pm at DHMC.
The highly anticipated proposed revisions to the rules protecting human subject research have been released. We have planned two forums to discuss the proposed changes
with the research community. Organizations are encouraged to submit comments - the comment period ends December 7th, 2015. If implemented the expected date of finalization is anticipated in late 2016 followed by a one to three year implementation
period (depending on the topic).
Forums:
·
Oct. 13th Aud H at Dartmouth-Hitchcock Medical Center 5 – 6 pm
·
Oct 21st Kemeny Hall Bloom/Chao Classroom (007) at Dartmouth College campus 5 – 6 pm
Please RSVP to
[log in to unmask] if you would like
to attend or need directions to the meeting areas.
The complete document can be found at:
http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf.
(do not print - this is a 500 page document)
Summary of the Major Provisions of the Proposed Regulatory Action
1)
Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects,
and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.
2)
Generally require informed consent for the use of stored bio specimens in secondary research (for example, part of a blood sample that is left over after being drawn
for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose bio specimen it is. That consent would generally be obtained by means of broad consent (i.e., consent for future, unspecified research
studies) to the storage and eventual research use of bio specimens.
3)
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.
4)
Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved
in the research. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review. Certain exempt and all non-exempt research would be required to provide privacy safeguards for bio specimens and identifiable
private information.
New categories include: a. certain research involving benign interventions with adult subjects; b. research involving educational tests, surveys,
interviews or observations of public behavior when sensitive information may be collected, provided that data security and information privacy protections policies are followed; c. secondary research use of identifiable private information originally collected
as part of a non-research activity, where notice of such possible use was given; d. storing or maintaining bio specimens and identifiable private information for future, unspecified secondary research studies, or conducting such studies, when a broad consent
template to be promulgated by the Secretary of HHS is used, information and bio specimen privacy safeguards are followed, and limited IRB approval of the consent process used is obtained.
5)
Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving bio specimens (regardless of identifiability)
will occur only in very rare circumstances.
6)
Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with
certain exceptions. To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance holding institution (“unaffiliated IRBs”), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance
with the Common Rule.
7)
Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing
data or involve only observational follow-up in conjunction with standard clinical care.
8)
Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt
human subjects research.
For additional information about the NPRM, including a brief summary of the proposed changes, how to submit comments or browse posted comments, visit
http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html.