1. Human Research Protection Program (HRPP) Brown Bag Series October 2017
ELIZABETH BANKERT
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS
Updates

2. Certificate of Confidentiality
NIH Definition of Clinical Trial
NIH single IRB of Record (sIRB)
Common Rule implementation : Non-renewal minimal risk - Expand exemption category
Updates : consent form template

3. Certificate of Confidentiality (CoC)
Changes to NIH Policy for Issuing CoC
Effective Date: October 1, 2017   
The update is a result of the need to implement the 21st Century Cures Act, which states that the Secretary, HHS shall issue C of C to persons engaged in biomedical, behavioral, clinical or other research, in which identifiable, sensitive information is collected.  These Certificates protect the privacy of subjects by limiting the disclosure of identifiable, sensitive information.

4. “identifiable, sensitive information” means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research, where the following may occur:
An individual is identified; or
For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.
This Policy also acknowledges that the NIH will continue to consider request for Certificates for non- federally funded research in which identifiable, sensitive information is collected or used.

5. Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, and is within the scope of this Policy is deemed to be issued a Certificate through this Policy and is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act.
Previously, NIH provided these protections through the issuance of Certificates only upon receipt and approval of an application

6. Recipient Responsibilities:
the recipient of the Certificate shall not:
Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or
Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

7. Disclosure is permitted only when:
Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;
Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
Made with the consent of the individual to whom the information, document, or biospecimen pertains; or
Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

8. NIH funded CoC recipients are required to establish and maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of award.
are required to ensure that any investigator or institution not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate issued by this Policy, understand they are also subject to the requirements of subsection 301(d) of the Public Health Service Act. 
Recipients are also responsible for ensuring that any subrecipient that receives funds to carry out part of the NIH award involving a copy of identifiable, sensitive information protected by a Certificate issued by this Policy understand they are also subject to subsection 301(d) of the Public Health Service Act.
For studies in which informed consent is sought, NIH expects investigators to inform research participants of the protections and the limits to protections provided by a Certificate issued by this Policy

9. NIH Definition of Clinical Trial
A research study in which 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 those interventions on health- related biomedical or behavioral outcomes.  

10. NIH developed case studies to clarify the definition using the following four questions:
Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect being evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is “yes,” then the clinical study would be considered a clinical trial according to the NIH definition.  Expect the case studies and related guidance to evolve over the upcoming year. 
Case studies :

11. NIH single IRB of Record (sIRB)
NIH funded research:  Applications submitted on or after January 25, 2018 for multi-site non-exempt research involving human subjects for new or competing renewals must describe the use of a single IRB.
In general, the prime awardee organization will provide IRB review for the entire project (all sites). The application must identify the IRB of Record (which is subject to the approval of the funding agency).
If the Dartmouth CPHS is the proposed IRB of Record, please contact the CPHS early on in the proposal development phase.

12. If you are developing or a receiving a subcontract for a NIH funded new study or submitting a competing renewal of a multi-site study involving human subjects please contact CPHS for a discussion including:
 -      Is Dartmouth the lead site (site receiving NIH funding)?
-      Will Dartmouth be a site on a proposal being submitted by another institution?
-       Has the IRB of Record been determined? 
-       Fee structure – research coordinator, IRB of Record
-       Dartmouth responsibilities
IRB Reliance Agreements do not need to be in place at the time of application.
IRB Reliance Agreements must be in place prior to the initiation of human subject research at each site.
The IRB Reliance Agreement will describe the role of each site. IRB Reliance Agreements are managed by the Office of the Committee for the Protection of Human Subjects (CPHS) at Dartmouth.

13. - IRB of Record - Rely on another IRB
IRB of Record : Request to Rely Form (local site information)
IRB Reliance Agreement
SMART IRB
Roles and Responsibilities

14. Common Rule implementation - January 2018
Common Rule implementation - January Non-renewal minimal risk Expand exemption category

15. 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.

16. 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 – non renewal
6. Single IRB for U.S. based multi-site studies. Flexibility built in. (3 years effective day)

17. 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: no change in who makes exemption determination (this part of proposed rule was eliminated)

18. 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

19. 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.

20. Continuing Review – non renewal
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 *

21. Updates to CPHS consent form templates
Certification of Confidentiality
Patient Financial Services [remove phone #]
Reportable infectious diseases
Subject injury / illness

22. Thank you for your time !
November 7th Brown Bag: Doug Parr, Investigational Pharmacy
December 5th Brown Bag: Consent form summary