# Presentation: 664214

## ASSURANCE OF COMPLIANCE FOR PROTECTION OF HUMAN SUBJECTS 

-    **Freda E. Yoder**
- Division of Education and Development
**OSOPHS/OHRP**
**	****	****	****	**

## HUMAN SUBJECT RESEARCH CONDUCTED OR SUPPORTED BY DHHS IS SUBJECT TO

** ****Title 45, Code of Federal Regulations, Part 46 **
**                              ****(45 CFR 46) **
**	****Protection of Human Subjects**** **
**Subpart A - Federal Policy/Common Rule **
**Subparts B, C, and D  - additional protections for vulnerable populations           **
**   ****	****	****	****	****	****	****	**

## GENERAL REQUIREMENTS FOR CONDUCTING HUMAN SUBJECT RESEARCH

** ****Assurance of Compliance with the regulations –**
**     ****approved by OHRP**
***Certification [to funding entity] of Institutional***
***    ******Review Board (IRB)* review & approval***
***Legally effective informed consent of subjects***
**	****(Unless the research is exempt) **
**   ***** or Independent Ethics Committees (IEC)  **

##   RESEARCH

**systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge**
**	****	****	****45 CFR 46.102(d)**

## 	 HUMAN SUBJECT

**living individual about whom an investigator conducting research obtains: **
**(1)  data through intervention or interaction with the individual, or **
**(2)  identifiable private information.**
**	****	****	****45 CFR 46.102(f)**

## WHAT IS AN ASSURANCE OF COMPLIANCE?

**ASSURANCE:  agreement between an institution receiving funding or other federal support and the Department [providing support] that human subject research will be conducted in accordance with the regulations for the *****Protection of Human Subjects***** of research**
**  *****[OHRP is the designated office for DHHS]***

## WHO NEEDS AN ASSURANCE APPROVED BY OHRP?

**WHO NEEDS AN ASSURANCE APPROVED BY OHRP?**

**Exempt **
**Research**

**Institutions engaged in human research **
**covered by the [federal] policy and which is **
**conducted or supported by DHHS**

**Not DHHS conducted **
**     ****or supported **

**Notes:**
Exempt.  Certain kinds of low risk research is exempt from the requirements of the regulations.  For example, research in established educational settings involving normal educational practices or research involving survey or interview procedures unless the information is recorded in such a way that the subjects can be identified and any disclosure of the responses outside the research could place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.  These exemptions do not imply that the investigators have no ethical responsibilities to subject; they mean only that further IRB review may not be necessary and that the institution conducting exempt research does not need an assurance.
In no case should the investigator make the final determination of exemption from the regulations or assurance requirements.

## WHEN IS AN INSTITUTION ENGAGED IN HUMAN SUBJECT RESEARCH?	

**anytime its employees or agents (i) interact or intervene with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes**
**Note:  awardee considered engaged if human subject research occurs at any site **
***[see OHRP guidance on:  “Engagement of Institutions in Research”]***

## WHAT TYPE OF ASSURANCE SHOULD BE SUBMITTED TO OHRP?

**OLD SYSTEM - Negotiated **
**Multiple Project Assurance (MPA)**
**Cooperative Project Assurance (CPA)**
***Single Project Assurance (SPA)***
**International Project Assurance**
**IIAs, AII, NIA**
**       ****(includes required IRB documentation)**

**Notes:**
So now you have determined that you need an assurance.  What’s next.  First, go to the OHRP website.
All institutions eligible

Web-based

No OHRP review of individual applications, protocols, consent documents

Includes IRB registration process

Rely on own institutional IRB, other institutional IRB, or commercial review board

##    Simplified Assurance system developed in collaboration with other Federal Departments and Agencies for Federalwide use.   
      one Institution = one Assurance

-    **Simplified Assurance system developed in collaboration with other Federal Departments and Agencies for Federalwide use.   **
**      ****one Institution = one Assurance**

**Notes:**

The new Federalwide Assurance system was developed in collaboration with other Federal Departments and Agencies for Federalwide use – it was also made available for public comment
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Except in rare instances, the new FWA approach is intended as one Institution = one Assurance  - exceptions to this rule need to be approved on a case by case basis  

The Approval period 3 years
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## NEW PROCEDURE FOR FILING FWA

***  Terms of Assurance – domestic & international**
***  IRB/IEC Registration **
**	**
***  FWA Filing**

## 
Guiding Ethical Principles
*  Applicability – all federally supported research
*  Compliance with applicable regulations & Terms 
*  Written Procedures should be established
*  IRB responsibilities, scope, & support 
*  Informed consent requirements
*  Assurances for collaborating sites
*  Importance of education & training

**Guiding Ethical Principles**
***  Applicability – all federally supported research**
***  Compliance with applicable regulations & Terms **
***  Written Procedures should be established**
***  IRB responsibilities, scope, & support **
***  Informed consent requirements**
***  Assurances for collaborating sites**
***  Importance of education & training**

**Notes:**

Separate Terms for Domestic & International
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Ethical Principles
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Applicability
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Compliance with regulations
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Written Procedures
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Others
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The Old complex Assurance system with all its permutations is to be replaced by two separate, but simplified processes:
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** **

**IRB REGISTRATION - REQUIRED FOR IRBS DESIGNATED ON AN FWA**

***  Identification of one or more IRB**
***  List of IRB Members by name**
***  Earned degrees**
***  Representative capacity**
***  Indications of experience, sufficient to**
**     ****describe anticipated contributions**
***  relationship/affiliation with institution**

## Commitment to Terms of Assurance and
*  Name of Institution Filing Assurance
*  Legal Components
*  Statement of Principles
*  Applicability – Procedural Standards
*  Designation of IRB(s)/IEC(s)
*  Human Protections Administrator
*  Signature of  authorized official of institution 
*  DHHS (OHRP) Approval – assign FWA Number

**Commitment to Terms of Assurance and**
***  Name of Institution Filing Assurance**
***  Legal Components**
***  Statement of Principles**
***  Applicability – Procedural Standards**
***  Designation of IRB(s)/IEC(s)**
***  Human Protections Administrator**
***  Signature of  authorized official of institution **
***  DHHS (OHRP) Approval – assign FWA Number**

**Notes:**
The actual FWA document is a 3 to 4 page, fill in the blanks form, consisting of the following key elements  
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the overreaching element of an Assurance is a commitment to the Terms of the Assurance – the Terms of Assurance for both the domestic and international institutions are posted at the OHRP website – CRUCIAL that key admin read & understand Terms of assur
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The first item is the identification of the Institution Filing Assurance  - this may appear to be a simple to name the institution that should filing an Assurance -  but it is amazing how easy it is to get this wrong – the assurance is intended to be a commitment from an institution and all its component – so the Assurance needs to be in the name of the institution, not in the name of one of its components or departments -
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## 
*  IRB & FWA Documents Received (last 60 days)
    (Identifies contact)
*  Registered IRBs & IECs 
*  Institutions with OHRP approved FWAs
*  Institutions with limited Assurances

http://ohrp.osophs.dhhs.gov/irbasur.htm

***  ****IRB & FWA Documents Received (last 60 days)**
**    ****(Identifies contact)**
***  Registered IRBs & IECs **
***  Institutions with OHRP approved FWAs**
***  Institutions with limited Assurances**
_**http://ohrp.osophs.dhhs.gov/irbasur.htm**_

**Notes:**
Once an IRB is registered, the registration is listed at OHRP’s website along with a LIST of other APPROVALS & other RELATED INFORMATION  -  the public will find the following information:
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IRB/FWA documents, past 45 days  - documents that have been pending for more than 45 days are not listed and will not be found at the website  
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The is a separate listing for all Registered IRBs & IECs  and 
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Institutions with OHRP approved FWAs
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Institutions with limited Assurances
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You will find the website address on your handout
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## *  New IRB Registrations and FWA Filing can be completed electronically – signature page of FWA form must be submitted to OHRP
*  Reduces paperwork burden on institutions and Federal Departments and Agencies
*  OHRP approved FWA accepted by other Federal Departments & Agencies
*  Institution’s commitment to human subject protections not reduced 

***  New IRB Registrations and FWA Filing can be completed electronically – signature page of FWA form must be submitted to OHRP**
***  Reduces paperwork burden on institutions and Federal Departments and Agencies**
***  OHRP approved FWA accepted by other Federal Departments & Agencies**
****  Institution’s commitment to human subject protections not reduced ***

**Notes:**
The new FWA IS SIMPLIFIED ASSURANCE process  
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FWA streamlines the Assurance process
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It Reduces paperwork burden on institutions and Federal Departments and Agencies
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OHRP approved FWA accepted by other Federal Departments & Agencies

although the paperwork and certain other burdens have been reduced for both the federal departments and agencies and the institutions, this should not be misconstrued to suggest the institutional responsibilities and accountability for assuring protections are less  
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## CONTACT OHRP

**IRB Registration or Assurances questions,   contact designated coordinators: **
**    **_[http://ohrp.osophs.dhhs.gov/daqi-staff.htm](http://ohrp.osophs.dhhs.gov/daqi-staff.htm)_
**General guidance or questions:**
**    ****web page:  **** **_[http://ohrp.osophs.dhhs.gov](http://ohrp.osophs.dhhs.gov/)_
**    ****e-mail:  **_[OHRP@osophs.dhhs.gov](mailto:OHRP@osophs.dhhs.gov)_
**    ****phone:  301-496-7005**

**Notes:**
I’d like to end by saying that today I’ve offered you the ABC’s of regulatory compliance, responsible research means treating those who participate as subjects with the full measure or respect and dignity that they are due.

** **