1. Dartmouth CPHS February 7, 2017
Dartmouth Human Research Protection Program (HRPP) Brown Bag Series: First Tuesday of the Month The Revised Common Rule federally funded human subjects research regulations
Dartmouth CPHS
February 7, 2017

2. Timeline January 18 2017- publication of Final Rule
1979 Belmont Report. Basic ethical principles (respect, beneficence, justice) with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.
1991- Common Rule (added many other agencies)
2011- Advanced Notice of Proposed Rule Making (ANPRM)
Public comment period
2015- Notice of Proposed Rule Making (NPRM)
January publication of Final Rule
Effective January 2018
Notes: may be rescinded, can implement prior to 2018

3. Intent of new regulations :
Increase protections for research subjects while facilitating research and
reducing administrative and resource burden.
Reflect shifting landscape of research over past two decades.

4. Significant Changes
1. Consent Form: new wording requirements, process, public posting
2. Broad consent: new term
3. Limited IRB review: new term
4. Expand Exempt categories (including prospective chart review, benign behavioral interventions)
5. Continuing Review of minimal risk research
6. Single IRB for U.S. based multi-site studies. Flexibility built in. (3 years effective day)

5. 1. Consent Form Requirements
Requires that informed consent begin with a “concise and focused presentation of the key information” likely to help a prospective subject understand the reasons for and against participation. The information must be organized and presented in a manner that facilitates comprehension.

6. A prospective subject or
legally authorized representative must be
provided with the information that a reasonable person
would want to have in order to make an
informed decision about whether to participate,
and an opportunity to discuss that information.
“In general, our expectation is that this initial presentation of the
key pieces of information will be relatively short.
This section of the consent could, in appropriate
circumstances, include a summary of relevant pieces of
information that are explained
in greater detail later in the consent form.”

7. Additional elements of informed consent have been added:
Language to indicated identifiers might be removed from
identifiable private information or biospecimens
and whether such information or biospecimens could
or will not be used for future research studies
without additional informed consent.
In addition, “when appropriate,” one or more of the following
elements of information are to be provided:
information on whether biospecimens will be used for commercial profit;
whether results will be disclosed to the subject;
and whether the research might include whole genome sequencing.

8. Public Posting of Consent Forms
Requires the public posting of consent forms for federally funded clinical trials, (allows certain redactions)
Posting is made by the awardee or agency in a publically available federal repository
No restrictions on which version
Posting can take place any time after recruitment closes but not later than 60 days after last study visit by any subject

9. 2. Broad Consent Limited IRB Review
permits broad consent in lieu of specific consent with respect to the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent *
Limited IRB Review
Criteria for IRB approval *
IRB need not make determinations 1 – 6
IF broad consent for storage, maintenance, and secondary research use of identifiable private information
of biospecimens is obtained, appropriately documented or waiver of documentation is appropriate.
And if there is a change made for research purposes in the way the identifiable private information
or identifiable biospecimens are stored or maintained, there are adequate provisions to protect privacy
of subjects and maintain confidentiality of data

10. Broad Consent
COGR
Six additional elements of consent are required for broad consent none of which can be omitted or altered
where broad consent is solicited.
Including
“a general description of the types of research that may be conducted”;
a description of the identifiable information or biospecimens that might be used in research,
whether sharing might occur, and the types of institutions or researchers that might conduct the research;
a description of the period of time identifiable information and biospecimens might be stored
and used for research;
a statement that the subject will not be informed of the details of any specific research studies
that might be conducted…and that subjects might have chosen not to consent to some of those
specific research studies”;
unless determined otherwise a statement that research results may not be disclosed to the subject;
and contact information for questions
and “in the event of a research-related harm.”

11.  §46.111 Criteria for IRB approval of research.
 (1) Risks to subjects are minimized
 (2) Risks to subjects are reasonable in relation to anticipated benefits
 (3) Selection of subjects is equitable
 (4) Informed consent
 (5) Informed consent will be appropriately documented
 (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
 (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

12. 4. Expansion of Exemption Categories Exemption for prospective and identifiable data review
(#4) secondary research for which consent is not required: Use of identifiable private information or identifiable biospecimens if one of the following is met:
Publicly available
Recorded information cannot readily be identified, investigator does not contact subjects and will not re-identify the subjects
if the research is already subject to the Health Insurance Portability and Accountability Act (HIPAA) rules.
Note: “secondary” is new wording used to describe data collected for a different primary purpose which could be non-research OR research.
Note: no change in who makes exemption determination (this part of proposed rule was eliminated)

13. Expansion of Exemption Categories
Secondary research with broad consent
(#7) Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited review.
(#8) use of information or specimens previously stored or maintained under exemption #7

14. Expansion of Exemption Categories
New Category: (3)(i) Benign behavioral interventions
Benign behavioral interventions with collection of information from adult subjects who prospectively agrees. As long as at least one of the following is met:
Recorded information cannot readily identify the subject
Disclosure of responses outside of the research would not place subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, educational advancement, or reputation
If recorded information is identifiable- IRB can conduct a limited review

15. Expansion of Exemption Categories
(3)(i) New Category: Benign Behavioral Intervention
“brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.”
If deception is involved, subject must prospectively agree (to qualify for this category of exemption). Meaning the subject agrees to participate in research in which s/he is informed that s/he will be unaware of or misled regarding the nature or purposes of the research.
Deception- use example of text added to consent form/script: The purposes of this study are not described in detail because if they were, there would be a predictable effect on your responses. After the experiment, you will have an opportunity to discuss any questions pertaining to the study with the research team.

16. 5. Continuing Review IMPORTANT NOTES:
Unless an IRB determines and documents* otherwise,
Continuing review is NOT required for :
Minimal Risk research (expedited, limited, exempt)
Studies that have progressed to data analysis (can be identifiable) AND/OR follow-up clinical data from procedures that subjects would undergo as part of clinical care (not specifically for the research)
IMPORTANT NOTES:
Not applicable for FDA regulated research
Not applicable if a change is ‘more than minimal risk’
Not applicable if a change to purpose, population, procedures = new study
May not be applicable for vulnerable populations *

17. 6. Single IRB for multi-site research
Will require that multi-site research use a single IRB for the portion of the research conducted in the U.S., except if prohibited by law or determined inappropriate by any federal Department or Agency supporting or conducting the research.
Flexibility in allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.

18. And more --- details, details, details .
New description of vulnerable populations that does not include pregnant women
HHS Secretary will evaluate and can amend the expeditable list every 8 years

19. Plan for implementation :
Continuing review
Expand exempt categories,
Change consent form templates
Single IRB review

20. Thank you for your time.
Questions ?