Archive

Archived 6/28/2011

Ethical Issues in Global Health Research

June 20 – 24, 2011

Archived 1/21/2011

Join us for future events hosted by OHRA including our upcoming Ethical Issues in Global Health Research 12th Annual Summer Workshop!

Thank you to all who participated in OHRA’s November 16th Open House!

We take your comments and suggestions seriously. Please find the results from the OHRA Satisfaction Survey completed at the Open House. We look forward to addressing any concerns. Please contact us anytime to let us know how we may serve you better.

Our staff enjoyed meeting the research community and seeing familiar faces.

Congratulations to the raffle winners and to those who scored 100% on the OHRA Investigator Manual Scavenger Hunt (correct answers can be found in the slide show below)!

A’Nova Ettien

Katie Herz

Rio Holaday

Molly Pretorius Holme

Sarah Meyers-Ohki

Michael Roy

 

For those of you who were not able to attend the event please enjoy the Open House slide show and pictures from the event!

 

Archived 12/3/10

OHRA is in the Process of Seeking AAHRPP Accreditation!

What is AAHRPP?

The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is an independent, non-profit accrediting body, which uses a voluntary, peer-driven, educational model to ensure that Human Research Protection Programs (HRPPs) meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence-through policies, procedures, and practices-of their commitment to scientifically and ethically sound research and to continuous improvement. Nearly 200 institutions have received full accreditation status from AAHRPP.

What is AAHRPP Accreditation?

Although frequently referred to as IRB accreditation, accreditation from AAHRPP covers the entire Human Research Protection Program (HRPP). To achieve accreditation requires meeting performance standards in following five Domains: organizational/institutional commitment, research review unit including IRB operations, Investigators’ understanding and fulfilling of their responsibilities, sponsored research oversight and management, and participant/community outreach. Altogether, there are 20 AAHRPP Standards within five Domains, and 77 Elements under 20 Standards.

What is AAHRPP Accreditation Process?

AAHRPP accreditation is a two-step process, namely self-assessment and AAHRPP on-site visit. Starting August 2008, the Office for Human Research Administration (OHRA) has embarked on the Step 1 self-assessment process, which is intended to strengthen HSPH’s HRPP, as well as to meet AAHRPP accreditation standards. The self-assessment included reviewing, revising and developing policies and procedures for HSPH’s Human Research Protection Program, which is comprised of IRB Operations, Quality Improvement Program (QIP), and relevant key individuals, departments, and units.

The Step 2 on-site visit occurs 3 – 4 months after AAHRPP receives our application. The purpose for the site visit is to evaluate the implementation of our policies and procedures. The AAHRPP site visitors will interview institutional and organizational officials, IRB Chairs and Members, Investigators, research assistants/coordinators. To fully evaluate our HRPP, the site visitors will also be permitted and have access to all study-related records such as protocols, consent forms, recruitment materials, IRB meeting minutes, and audit reports. Accreditation occurs following a successful site visit and evaluation, usually 3-6 months after the completion of AAHRPP on-site visit.

AAHRPP Accreditation Related Changes – How will accreditation process affect the HSPH research community?

Meeting the AAHRPP appreciation standards requires changes/improvements to existing policies and procedures including relevant forms, templates, and checklists. The newly developed Investigator Manual will be posted to OHRA website by the end of September, along with applicable forms. A series of live education sessions for investigators and coordinators are scheduled to explain these changes. In addition, small group educational sessions, as well as one-on-one questions-and-answers will be offered through OHRA’s Quality Improvement Program (QIP). To learn more about OHRA’s education offers, please contact QA/QI Education Specialist Alyssa Speier, or HRPP Coordinator, Justin Fendo.

Tentative Timeline:

• August/September 2009: Finalizing AAHRPP application to AAHRPP
• December 2009: OHRA receiving draft agenda for the site visit including protocols to be reviewed and persons to be interviewed during on-site visit.
• February 3-5, 2010: On-site visit/evaluation
• March or June 2010: AAHRPP Council Review – determining accreditation status

Archived 11/19/2010

OHRA Open House

Changing Seasons…Changing Times

Please join the HSPH Office of Human Research as we welcome a new seasion of success in human research protection and support.

November 16, 2010

Kresge Cafeteria

3:00PM-5:00PM

Refreshments will be served.

Download the Schedule of Events here!

Make sure to complete and submit the Investigator Manual Scavenger Hunt (by November 15th) and OHRA Satisfaction Survey (at the open house) to win great prizes such as a Kindle, iPod, Gift Cards, and more!!!

Guest Speakers

Karen Emmons

Associate Dean for Research and Professor of Society, Human Development, and Health

David Hunter

Dean for Academic Affairs, Vincent L. Gregory Professor in Cancer Prevention

*Meet your Department IRB Review Specialist

*Get Your Questions Answered by IRB Chair, Investigators, Study Coordinators, and OHRA Staff

*Learn How QIP Can Provide You the Help You Need

*Opportunities to Get Involved in Developing, Updating, and Implementing OHRA Policies

Archived 10/4/2010

The Harvard School of Public Health (HSPH) is committed to protecting the rights and welfare of participants in Human Research. The organization’s Human Research Protection Program (HRPP) is a comprehensive system working together in order to ensure the protection of the rights and welfare of participants in Human Research. It is comprised of the HSPH leadership, Institutional Review Board (IRB), Quality Improvement Program (QIP), investigators and their study staff, and relevant departments and units.

The Office of Human Research Administration (OHRA) is composed of the IRB Operations and QIP and has actively been engaged in preparing for AAHRPP Accreditation. Towards this end, OHRA has updated its website, revised and streamlined its forms, and developed an Investigator Manual and HRPP Plan. Please familiarize yourself with our new and updated procedures.

Archived 2009

AWARE for All: 5th Annual Boston Clinical Research Education Day

AWARE for All is an educational program that is free and open to the public for the purpose of providing education to help people make informed decisions about clinical research participation. Download informational brochure. Register here.

Your Feedback is important to us…

If you have any ideas or suggestions to make our program the best that it can be, please take our 10 question QIP survey!

 

New Director of Human Research Administration Builds Bridges Between Researchers and IRB

Harvard Public Health NOW Article, October 24, 2008

Delia Wolf, MD, JD, is uniquely qualified to bridge the gap between researchers and Institutional Review Boards (IRB), which ensure regulatory compliance for studies that involve human subjects. Read more.

An Announcement from Dean Lichten

Dear Colleagues,

I am pleased to announce that Delia Wolf, MD, JD has joined Harvard School of Public Health (HSPH) as the Director of the Office of Human Research Administration (formerly Human Subjects Administration). In this role, Delia is responsible for the HSPH human research protection program. Read more.

New Name, New Leadership, and a Whole New Program

We are excited to announce that we are undergoing significant office changes to make our resources more accessible and to provide the highest quality services to the HSPH research community. You will notice that we have changed our name from “Human Subjects Administration” (HSA) to “Office of Human Research Administration” (OHRA). In addition, the “Human Subjects Committee” (HSC) is now the “Institutional Review Board” (IRB).

With these name changes, we also welcome a new Director, Delia Wolf, MD, JD, and a new Associate Director, Julie Kaberry, MHP. In our continued efforts toward efficiency and greater quality of IRB review, we have reorganized our office and streamlined our review process, which will lead to a more timely turn around of IRB submissions. This reorganization includes new submission forms, revised policies and procedures, and a user friendly website.

To better assist investigators and their research teams, we have also established a Quality Improvement Program (QIP), which offers on-going education and support through a range of customized services. This new program is led by Leslie Howes, MPH.

New Services

Department Assignments

We have designated a Protocol Administrator and a Review Specialist to each department in an effort to facilitate the IRB review and approval process. All exemption requests will now be conducted by one designated Review Specialist. Click here to find your department contact.

Quality Improvement Program (QIP)

Our new Quality Improvement Program (QIP) is dedicated to the support and ongoing education of the HSPH research community. Through a range of services, QIP will provide focused education and onsite reviews to investigators and their research teams; serve as a liaison between investigators and the IRB to ensure effective communication; and offer the tools and guidance needed to meet regulatory and insitutional requirements. Read more.