UTHSC Pursues Accreditation for Our Human Research

Protection Program (HRPP)

From http://www.aahrpp.org/learn/accreditation/goals-principles-standards

Goals of Accreditation

• “Improve the systems that protect the rights and welfare of individuals who participate in research”

• “Communicate to the public the strength of an Organization’s commitment to the protection of human research participants”

Why should we pursue accreditation?

• To evaluate UTHSC’s research policies and procedures for accuracy, consistency, & thoroughness in regards to federal regulations and guidance

• To formalize interaction and communication across all UTHSC research boards, committees, offices, units, and personnel

• To reduce the risk of research non-compliance on campus

• To look at more efficient ways of protecting human participants

• To attract sponsors who want to conduct research with accredited organizations

*from December 4, 2014 PRIM&R preconference workshop, AAHRPP PowerPoint presentation

The Association for the Accreditation of Human Research Protection Programs,

Inc. (AAHRPP)

• Nonprofit organization

• Founded in 2001

• Has accredited 198 organizations representing 600 entities*

• The only long-standing, reputable, and global accrediting organization

*from http://www.aahrpp.org/learn/news-releases

Types of Organizations Accredited by AAHRPP

• Academic Institutions (over 65% of U.S. medical schools are accredited or in the process*)

• Hospitals (such as St. Jude Children’s Hospital)

• Independent IRBs (such as WIRB)

• Sponsors (such as Pfizer)

• Contract Research Organizations (CROs, such as Celerion, Inc.)

• Government (such as National Institutes of Health NCI CIRB and some VA facilities)

• Research Institutions (such as National Marrow Donor Program)

• Dedicated Research Sites (such as Miami Research Associates, Inc.)

From http://www.aahrpp.org/learn/news-releases

Where are AAHRPP accredited organizations?

• 46 U.S. states

• Canada

• China

• India

• Mexico

• Republic of Korea

• Saudi Arabia

• Singapore

• Taiwan

What is a Human Research Protection Program (HRPP)?

• A Human Research Protection Program is made up of all boards, committees, offices, units, and personnel at an organization who contribute to the protection of human research participants.

• The IRB is not the entity pursuing accreditation.

• The HRPP of UTHSC is pursing accreditation, and this includes you!

UTHSC HRPP Components

• Research coordinators, nurses, & staff

• Investigators (PIs, Co-Is, Sub-Is)

• Institutional Review Board (IRB Chair, Board members, & staff)

• Institutional Biosafety Committee (committee members & staff)

• Radiation Safety Committee (committee members & staff)

• Grants and Contracts

• Finance and Operations

• Office of Clinical Research

• UT Research Foundation

• Research Administration

• Our client institutions (such as Methodist, Le Bonheur, & Regional One Health)

The Accreditation Process: Self-Evaluation

• We will conduct a self-evaluation using AAHRPP’s 130-page instrument.

• We must review all HRPP policies & procedures (not just IRB p & p) to ensure that all 60 elements under the 15 AAHRPP standards are met.

• This will require review and revision of current p & p, creation of new p & p, and putting revised and new policies and procedures into practice.

• This will take several months.

Example of AAHRPP standard

• Standard III-1: In addition to following applicable laws and regulations, Researchers and Research Staff adhere to ethical principles and standards appropriate for their discipline. In designing and conducting research studies, Researchers and Research Staff have the protection of the rights and welfare of research participants as a primary concern.

Example of AAHRPP Elements under Standard III-1.

• III.1.A. Researchers & Research Staff know which of the activities they conduct are overseen by the HRPP, and they seek guidance when appropriate.

• III.1.B. Researchers & Research Staff identify and disclose financial interests according to organizational policies and regulatory requirements and, with the Organization, manage, minimize, or eliminate financial conflicts of interest.

• III.1.C. Researchers employ sound study design in accordance with the standards of their discipline. Researchers design studies in a manner that minimizes risks to participants.

• III.1.D. Researchers determine that the resources necessary to protect participants are present before conducting each research study.

Step 1 Application

• When the self-evaluation is complete, we must submit a Step 1 application to AAHRPP.

• This application will include:

Application for Accreditation

Overview of our HRPP and explanation of each component’s responsibility in protecting human subjects

Element-by-element index to supporting documents

Supporting documents from all components of our HRPP

IRB Rosters including requested details about members

Response to Step 1 Application

• We will receive AAHRPP’s response within 30 business days

• If they have questions, comments, or requested revisions, we can respond only 1 element at a time.

• Once the element in question is satisfactory, we can begin to answer the 2nd element in question.

• This process must be completed within one year of the date we submitted the Step 1 application.

Step 2 Application

• Within 10 business days of AAHRPP’s approval of our Step 1 application, we must submit our Step 2 application.

• This application will include:

All parts of the Step 1 application, revised to incorporate any and all changes we have made since its submission

Meeting minutes, any government correspondence, and an internal audit summary for the last year

Complete list of active protocols for the last year, including requested details about them

List of key personnel involved in HRPP including role

Site Visit

• Will occur no less than 50-55 business days before the Council meeting date

• Site visit will include several days of:Review of iMedRIS for consistency with policies and procedures submitted in

Step 2 application

Interviews of key personnel in HRPP (this includes you!) regarding knowledge of your role in HRPP, your practices according to HRPP polices and procedures, and how you communicate with the other components of the HRPP

Evaluation of how our HRPP components work together to protect research participants

End-of-day meetings with Lead Contact at UTHSC with questions and possible revision requests

Response to Site Visit

• AAHRPP will send us a draft site visit report within 20 business days.

• We must respond to this draft site visit report within another 20 business days.

• Our final site visit report is reviewed at the next quarterly Council meeting, and a determination is made regarding accreditation.

What does all this mean for me?• Research coordinators, nurses, & staff

• Investigators (PIs, Co-Is, Sub-Is)

• Institutional Review Board (IRB Chair, Board members, & staff)

• Institutional Biosafety Committee (committee members & staff)

• Radiation Safety Committee (committee members & staff)

• Grants and Contracts

• Finance and Operations

• Office of Clinical Research

• UT Research Foundation

• Research Administration

• Our client institutions (such as Methodist, Le Bonheur, & Regional One Health)

What do I need to do?

• If you are on a committee or in an office or unit in our HRPP, send me your policies and procedures (or a link to them if they are current on the website)

We may be requesting revisions of those policies in order to meet one or more AAHRPP elements/standards; please revise them promptly and/or call us to discuss

• All personnel involved in our HRPP must become familiar with the HRPP policies and procedures that apply to their role in the HRPP

IRB Standard Operating Procedureshttp://www.uthsc.edu/research/research_compliance/IRB/policies.php

Accreditation- An Ongoing Process

• Once we receive full accreditation status, we will display the AAHRPP seal on the IRB website

• In order to maintain accreditation, we must do the following:

Maintain adherence to our HRPP’s accredited policies and procedures (and by doing so, adhere to the federal regulations for the protection of research participants)

Maintain metrics for the AAHRPP-required annual report

Maintain programs begun specifically for accreditation (and not required by federal regulations)

Provide prompt status reports when requested by AAHRPP

Accreditation- An Ongoing Process

• In order to maintain accreditation, we must do the following (cont’d):

Provide prompt annual reports

Inform AAHRPP of any major changes to our HRPP and/or our p & p

Inform AAHRPP within 24 hours of any sanctions by government offices or any lawsuits related to human research protection

Allow site visits if we have had any major changes, sanctions, or lawsuits

Maintain accreditation records for 10 years from date of accreditation

Pay annual fees

Reaccreditation

• The first accreditation period granted is only 3 years; however, every reaccreditation period thereafter will last 5 years.

• The process is essentially the same as that required for accreditation.

• We must submit our Step 1 Application 12 months before the Council meeting to which we are assigned for reaccreditation review.

AAHRPP Element under Standard III-1.

• III.1.B. Researchers & Research Staff identify and disclose financial interests according to organizational policies and regulatory requirements and, with the Organization, manage, minimize, or eliminate financial conflicts of interest.

Pop Quiz

•Where in iMedRIS do you disclose financial interests?

Section (3300)

Pop Quiz

•What does the IRB’s Conflicts of Interest policy say?

Significant Financial Interest

Means anything of monetary value, including but not limited to:

• The value of any remuneration received from a publicly traded entity in the previous 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000; or

• The value of any remuneration received from a non-publicly traded entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when any individual among the key study personnel holds any equity interest in that entity; or

• Intellectual property rights and interests (patents, trademarks or copyrights) are held in the drug, device or other article being tested, and income related to such rights and interest has been received.

Applies to key research personnel and their spouses, parents, and children

IRB Conflict of Interest Policy cont’d

• If a conflict is reported, the IRB will not approve the study until the conflict of interest is reviewed by the UTHSC Finance and Operations Office and a plan for managing those interests has been formulated and approved by that office under the provisions of Fl0125 Conflicts of Interest.

• Plans for managing financial conflicts of interest of investigators and other key research personnel must be reviewed and approved by the full Board.