WITH US:

05/04/05 – Women's Business Enterprise National Council has granted CGIRB status as a certified Woman Owned Business. To read more, visit WBENC.

03/28/05 – CGIRB annouces its affiliation with CITI, the Collaborative IRB Training Initiative group. This web based training program is available free of charge to Investigative sites with protocols under CGIRB’s approval. The purpose of the CITI program is to develop, implement and maintain a high quality web based educational program in the protection of human subjects in research. The CITI Program was founded by Karen Hansen at the Fred Hutchinson Cancer Research Center and Paul Braunschweiger Ph.D. at the University of Miami in March 2000. To find out more about the CITI program in general, go to https://www.citiprogram.org/citidocuments/aboutus.htm and to find details on registering through Copernicus Group IRB, go to the training information section.

03/23/05 – CGIRB has entered into a co-marketing agreement with IntraLinks, Inc., a leading provider of secure on-demand workspaces to the life sciences industry. Under the terms of the agreement, IntraLinks will help expedite the flow of information among members of the pharmaceutical community and CGIRB will leverage IntraLinks' drug development hub to speed the clinical trial process. For additional information please view the Press Release.

07/30/04 – Copernicus Group IRB was awarded Full Accreditation of our Human Research Protection Program (HRPP) by AAHRPP®, The Association for the Accreditation of Human Research Protection Programs, Inc. We are excited to receive recognition for our program designed to protect human research subjects.

02/25/04 – Congratulations to the following Copernicus Group staff members for receiving the Certified IRB Manager (CIM) certification. They are: Sherry Seabock - Project Team Leader, Jessica Gant - Project Assistant and Tammy Sayers Lesko - Director of QA and Regulatory Compliance.

They join other staff members, Christy Fleming, who previously received her CIM and Dawn Pope and Sharon Hill Price who received the Certified IRB Professional (CIP) certification several years ago.

12/22/03 – David Borasky was elected ARENA’s President for 2004. He will begin his term on January 1, 2004.

CONFERENCES & EVENTS:

02/25/08-02/27/08 – Clinical Trials Congress will be held in Orlando, FL. CGIRB will be in Booth 409. Contact Will Stewart , Director Business Development and Marketing.

02/24/08-02/26/08 – AAHRPP® Conference will be held in Minneapolis, MN at the Hilton Minneapolis.

Planned Attendance:

• Sharon Hill Price, Founder and Chief Executive Officer, Copernicus Group IRB
• Lysa Triantafillou, Director, Quality Assurance & Regulatory Compliance
• Megan Aiken, CIP, Principal IRB Administrator

Presentations:

• Sharon Hill Price, Founder and Chief Executive Officer, Copernicus Group IRB: "IRB Quality Improvement through Accreditation"

02/12/08-02/15/08 – Drug Development Summit - Amelia Island, FL. CGIRB will be in Booth 104. Contact Will Stewart, Director Business Development and Marketing.

12/01/07-12/04/07 – Public Responsibility in Medicine and Research (PRIM&R) 2007 Annual Human Research Protection Programs (HRPP) Conference will be at the Sheraton Boston and Hynes Convention Center, Boston, MA.

11/30/07 – Please join the North Carolina Chapter of SQA (NCCSQA) in Durham, NC for the NCCSQA 2007 4th Quarter Program. This program is entitled 2007 A Year in Review: New Documents and Interpretations and is followed by the NCCSQA Holiday Luncheon. Details on the program can be found on the online registration web page: http://sqa.org/shopsite_sc/nccsqa4qtr07.html.
Presentations:

• Lysa Triantafillou, CGIRB Director, Quality Assurance & Regulatory Compliance: "Reporting Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others: A Summary and Comparison of the Two Recent Guidance Documents"

06/17/07-06/21/07 – DIA will be held in Atlanta, GA. CGIRB will be exhibiting in Booth 1630. Contact: Will Stewart, Director of Business Development. http://www.diahome.org/DIAHome/FlagshipMeetings/home.aspx?meetingid=11362

05/06/07-05/09/07 – BIO will be held in Boston, MA. CGIRB will be represented by Will Stewart. Contact: Will Stewart, Director of Business Development. http://www.bio2007.org/

04/29/07-05/03/07 – SQA will be held in Austin, TX. CGIRB will be exhibiting in Booth T2. Contact: Will Stewart, Director of Business Development. http://www.sqa.org/am2007/

04/20/07-04/24/07 – ACRP will be held in Seattle, WA. CGIRB will be exhibiting in Booth 410. Contact: Will Stewart, Director of Business Development. http://www.acrp2007.org/acrp2007/public/enter.aspx

04/10/07-04/12/07 – Partnership with CROs will be held in Orlando, FL. CGIRB will be exhibiting in Booth 627. Contact: Will Stewart, Director of Business Development. http://www.iirusa.com/cropartners/2000.xml

02/26/07-02/27/07 – AAHRPP® will be held in Baltimore, MD. CGIRB will be exhibiting. Sharon Hill Price will chairing a presentation entitled "Financial Cost of Accreditation". Contact: Will Stewart, Director of Business Development. http://www.aahrpp.org/www.aspx?PageID=201

02/06/07-02/08/07 – Clinical Trials Congress will be held in Las Vegas, NV. CGIRB will be represented by Will Stewart, Becka Sipes and Sherry Seakbock. Contact: Will Stewart, Director of Business Development. http://www.iirusa.com/clinical/1837.xml

11/20/06-11/21/06 – The OHRP National Conference on Alternative IRB Models: Optimizing Human Subject Protection will be held in Washington, DC. CGIRB will be represented by Sharon Hill Price, CEO and Mary Ann Fallon, COO. http://www.hhs.gov/ohrp/sachrp/documents/IRBProgram.pdf

11/15/06-11/18/06 – PRIMR: Public Responsibility in Medicine and Research. The Annual HRPP Conference for Human Research Protection Programs. CGIRB will be represented by Dawn Pope, Glenn Veit, Catherine Ratledge, Joyce Baird, and Lysa Triantafillou. Contact: Will Stewart, Director of Business Development. http://www.primr.org

09/25/06-09/26/06 – National OHRP Conference. Copernicus Group IRB is one of the sponsors of an upcoming National OHRP Conference to be held in NC this fall. The National Human Subject Protections Conference entitled, "Crossing the Line: What is Acceptable Risk?" will be held on Monday, September 25 and Tuesday, September 26, 2006, at the Sheraton Imperial Hotel and Convention Center in Durham, North Carolina. Local and nationally recognized speakers will participate. Space is limited, so please register early. Other sponsors of this conference are Duke University ,University of North Carolina at Chapel Hill, North Carolina State University, National Institute of Environmental Health Systems, Family Health International, Research Triangle Institute, the Environmental Protection Agency and Department of Veterans Affairs. Visit: http://dukeohrp2006.org for more information.

09/17/06-09/19/06 – BioFusion: A Global Bioscience Partnering Conference. Will Stewart will be attending and exhibiting during the Technology Showcase. Contact: Will Stewart, Director of Business Development. http://www.biosouth.org.

06/18/06-06/22/06 – 42nd DIA Annual Meeting will be held in the Pennsylvania Convention Center in Philadelphia, PA. Sharon Hill Price, CEO of CGIRB will be chairing a presentation titled "Effectively Protecting Human Subjects in Studies Conducted Outside the US". CGIRB will be in Booth #1837. Contact: Mary Ann Fallon, BSN, Chief Operating Officer; Jennifer Sodrel, Director of Business Systems.

05/04/06-05/05/06 – National Association of IRB Managers 15th Annual Conference will be held in the DoubleTree Hotel in Altanta, GA. Tammy Lesko will be presenting.

04/28/06-05/02/06 – ACRP 2006 Global Conference & Exhibition will be held at the Phoenix Convention Center in Phoenix, AZ. CGIRB will be in Booth #511. Contact: Mary Ann Fallon, BSN, Chief Operating Officer.

04/06/06-04/07/06 – SoCra will be held at the Sheraton Crystal City Hotel in Arlington, VA. Kim Watkins will be giving a presentation titled "How SOPs Can Ensure Subject Protection during Clinical Trial Conduct". Contact: Kim Watkins, Director, Project Management.

04/04/06-04/05/06 – 15th Annual Partnerships with CROs & Other Outsourcing Providers will be at The Mirage Hotel in Las Vegas, NV. Contact: Mary Ann Fallon, BSN, Chief Operating Officer; Jennifer Sodrel, Director of Business Systems.

02/26/06-02/28/06 – 2006 AAHRPP Conference - Quality Human Research Protection Program will be held at the Wyndham Phoenix in Phoenix, AZ. Contact: Tammy Lesko, Director of QA and Regulatory Compliance.

02/13/06-02/15/06 – Clinical Trials Congress will be held at the Caribe Royal All Suites Resort in Orlando, FL. Contact: Mary Ann Fallon, BSN, Chief Operating Officer.

02/07/06-02/10/06 – 19th Annual DIA e-Data Management Meeting will be held at the Philadelphia Marriott Downtown in Philadelphia, PA. Contact: Jennifer Sodrel, Director of Business Systems.

06/13/05-06/16/05 – DIA 41ST ANNUAL MEETING - Washington, DC
CGIRB will be exhibiting at the 2005 DIA Annual Meeting in Washington, DC. Stop by and see us at Booth 854 or give us a call to arrange a special time to meet during the conference to discuss your current project and/or upcoming needs. To reserve a special time slot please call Jennifer Sodrel, Client Relations Manager at 888-303-2224. We look forward to seeing you there!

04/02/05-04/06/05 – ACRP’S 29th ANNUAL NORTH AMERICAN CONFERENCE AND EXHIBITION - Orlando, FL
CGIRB will be exhibiting at the Annual ACRP Annual Conference in Orlando, FL. Stop by and see us at Booth 819 or give us a call to arrange a special time to meet during the conference to discuss your current project and/or upcoming needs. To reserve a special time slot please call Jennifer Sodrel, Client Relations Manager at 888-303-2224. Tammy Lesko, our Director of QA & Regulatory Compliance, is also presenting a topic on the Informed Consent Process on the 5th. We look forward to seeing you there!

03/13/05-03/15/05 – AAHRPP’s 2005 Conference for Quality Human Research Protection Programs - Atlanta, GA
Tammy Lesko, our Director of QA & Regulatory Compliance, will be presenting information regarding policies and procedures. Tammy will also be available to discuss the organization and steps involved in our accreditation achievement.

06/13/04-06/16/04 – DIA 40TH ANNUAL MEETING Washington, DC
Copernicus Group IRB will be exhibiting at this year's DIA Annual Meeting in Washington, DC. Stop by and see us at Booth 427 or give us a call to arrange a special time to meet during the conference to discuss your current project and/or upcoming needs. To reserve a special time slot please call Jennifer Sodrel, Client Relations Manager at 888-303-2224. We look forward to seeing you there!

05/15/04-05/19/04 – ACRP'S 28TH ANNUAL NORTH AMERICAN CONFERENCE AND EXHIBITION San Diego, CA
Copernicus Group IRB will be exhibiting at the Annual ACRP Annual Conference in San Diego, CA. Stop by and see us at Booth 714 or give us a call to arrange a special time to meet during the conference to discuss your current project and/or upcoming needs. To reserve a special time slot please call Jennifer Sodrel, Client Relations Manager at 888-303-2224. We look forward to seeing you there!

04/26/04-04/28/04 – Copernicus Group IRB will exhibit at the Partnerships with CROs conference in Orlando, Florida. If you plan to attend please drop by our booth to chat and enter our prize drawing.

12/04/03-12/07/03 – Several Copernicus Group Staff and IRB Members attended the Public Responsibility in Medicine and Research’s (PRIM&R’s) 2003 Annual IRB Conference and ARENA annual meeting in Washington, D.C. Tammy Lesko and John Faletta presented a workshop with Brian Murphy from SUNY on HIPAA implementation. ARENA presented the Gelsinger award to all non-scientific and unaffiliated community members serving as IRB members. CGIRB members Mary Ann McFarland and Willanna Griffin were in the audience to receive recognition for Copernicus Group’s community members. Others in attendance at the three day meeting were Dawn Pope, Sherry Seabock, Patience Stevens, and Sharon Hill Price.

10/25/03 – Copernicus Group participated as a sponsor of the 5th Annual conference for ACRP’s RTP Chapter. The conference topic was Risk Management and Resolve in Clinical Research and it was held at the North Carolina Biotechnology Center in the Charles Hamner Conference Center.

08/21/03 – Copernicus Group IRB was recognized as a Silver sponsor of the Annual Event and Silent Auction for the Hospice of Wake County. The Annual Event will take place on 11/21/03.

COMMUNITY SUPPORT:

"Zoom-In: Science at the Extremes" at Morehead Planetarium and Science Center – Copernicus Group IRB is a proud sponsor of the upcoming exhibit at Morehead Planetarium and Science Center (MPSC), entitled "Zoom-In: Science at the Extremes". The exhibit will highlight "the big and small of our everyday world through the study of a gamma ray burst discovery and an examination of the inner workings of a human lung", this according to Lauren Smith in a recent article in Sundial magazine. MPSC staff are developing the exhibit in conjunction with the UNC Cystic Fibrosis Pulmonary Treatment Research Center, NIH Roadmap Carolina Center for Nanotechnology Excellence and the UNC Departments of Physics and Astronomy and Chemistry.

"Zoom-In" is scheduled to open on February 23, 2007 and will run for approximately 18 months. The exhibit will feature information kiosks as well as interactive panels aimed at encouraging hands on learning. Morehead Planetarium receives over 130,000 visitors each year and hopes that new renovations and exciting interdisciplinary programs will continue to expand the visibility of this regional Science Center.

12/15/06 – CGIRB participated in the Salvation Army Angel Tree program and provided gifts for 50 children locally this past holiday season. In addition, we collected donations for the Food Bank of North Carolina to help those in need over the holidays.

04/30/06 – CGIRB will be sponsoring and participating in the Third Annual Race of Grace. This event is a 5K road race and walk, geared at raising money to make a difference in the lives of the needy in our communities.

02/01/06 – CGIRB provided financial support for a group of volunteers from UNC Nursing School and School of Public Health to visit the gulf coast to assist with the hurricane relief project.

UNC School of Nursing – CGIRB recently made a financial contribution to the UNC School of Nursing building addition at Carrington Hall. The contribution was used to up-fit a research project suite. Nursing school staff is currently using Suite 2700 to house a study group conducting research on how stress levels influence the development of cardiovascular disease in rural North Carolinians.

Historical Preservation – CGIRB has provided financial support for an award-winning interpretive orientation kiosk that has been installed at Cross Keys & Port Republic Battlefields in the Shenandoah Valley of Virginia. For more information, you can visit http://www.shenandoahatwar.org.

12/15/05 – CGIRB employees participated in the Salvation Army Angel Tree program, providing gifts to 40 needy children. In addition, CGIRB made a financial contribution to the Salvation Army on behalf of their clients throughout the year.

10/01/05 – CGIRB employees participated in a Habitat for Humanity deconstruction project saving materials from homes slated for destruction to resale at the Habitat re-use store. Proceeds from the sales go towards new Habitat construction.

05/09/05 – Gaddy Golf Classic to benefit Easter Seals United Cerebral Palsy at MacGregor Downs Country Club. Contact Jennifer Sodrel for information on how to participate.

04/17/05 – CGIRB will be sponsoring and participating in the Race of Grace 2005. This event is a 5K road race and walk, geared at raising money to make a difference in the lives of the homeless in our communities. http://www.raceofgrace.org

12/06/04-12/17/04 – CGIRB is collecting donations for the Food Bank of Central and Eastern North Carolina and for “Coats for Children”, which is a program sponsored by WRAL-TV.

11/16/04 – Copernicus Group IRB was a sponsor and attended the 25th Silver Anniversary Celebration Dinner and Auction for the Hospice of Wake County.

04/26/04 – Copernicus Group IRB will sponsor the Gaddy Golf Classic to benefit Easter Seals United Cerebral Palsy. This will be the fourth year that Copernicus Group has sponsored this event that raises money to help individuals with disabilities to become more independent.

04/25/04 – Copernicus Group IRB will sponsor the 1st Annual Race of Grace, a 5K road race, with proceeds going to address healthcare, homelessness and hunger. This year’s emphasis will be on healthcare for indigent families.

10/18/03 – Members of the Copernicus Group IRB team volunteered time with Habitat for Humanity of Wake County.

04/28/03 – Copernicus Group IRB was a corporate sponsor for the 10th Annual Gaddy Golf Classic which was held at MacGregor Downs Country Club, Ltd. The Gaddy Golf Classic is one of the programs from the United Cerebral Palsy of NC Inc.

REGULATIONS AND GUIDELINES:

12/13/05 – The Office for Human Research Protections (OHRP) The Office for Human Research Protections has recently launched its new Spanish web page: http://www.hhs.gov/ohrp/espanol/intro.htm.

• 45 CFR 46, subparts A, B, C, and D
• Step-by-Step Instructions to Register an IRB
• Instructions for IRB Updates
• Terms of the Federalwide Assurance (FWA)
• Step-by-Step Instructions for an FWA application
• Instructions for FWA Updates

OHRP believes this will help Spanish-speaking IRB members and investigators to better understand the requirements of 45 CRF 46, as well as to obtain IRB registration and FWA approval.

10/20/05 – The Office for Human Research Protections (OHRP) understands that the effects of Hurricanes Katrina and Rita have been devastating to areas in Louisiana, Texas, Alabama and Mississippi, and as a result, some human subject protection programs at institutions in the affected areas are unable to function, and may be unable to for some time. OHRP has prepared information to help institutions and institutional review boards (IRBs) manage the hurricanes' impact on oversight of research and research subject interventions. This information is available at http://www.hhs.gov/ohrp/policy/hurricane.html.

10/14/05 – The Office for Human Research Protections (OHRP) is soliciting public comment on a draft guidance document for Institutional Review Boards, investigators, research institutions, Department of Health and Human Services agencies that conduct or sponsor human subjects research, and other interested parties, entitled "Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others." The draft guidance can be viewed on the OHRP website at http://www.hhs.gov/ohrp/requests/com101105.html.

Comments should be submitted by 1/13/06 to OHRP by email at ohrp@osophs.dhhs.gov. Please include the term "Draft guidance on reporting adverse events" in the subject field. Alternatively, comments may be submitted by mail to:

CAPT Michael Carome, M.D.
U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

10/07/05 – The Office for Human Research Protections has recently released the Second Edition of the International Compilation of Human Subject Research Protections. The Second Edition encompasses 72 countries, lists standards issued by international organizations, includes updated information for General and Drug research, and provides a listing of the laws, regulations, and guidelines on privacy/data protection, human biological materials, and genetic research.

The Compilation now provides over 400 direct web links to each country's key organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers, and others to meet regulatory requirements to assure that research studies comply with applicable standards.

The Compilation can be accessed on the OHRP website:
http://www.hhs.gov/ohrp/international/index.html#NatlPol

To use the Compilation, click on the document title, go to page 5, and click on the country of interest.

10/03/05 – OHRP announces the availability of a new set of Frequently Asked Questions (FAQs) to help clarify issues related to research involving children.

You may access these FAQs from the OHRP website's Policy and Guidance page http://www.hhs.gov/ohrp/policy/index.html under the header "children," then "Research with Children FAQs"

The FAQs may also be accessed from the HHS homepage (http://www.hhs.gov), by selecting "Questions" at the top right of the page and then on the "Questions and Answers" page under the "Category" drop-down menu, selecting "Human Research," and sub-menu, selecting "Research With Children."

OHRP plans to continue expanding the number of FAQs on human subject protection issues.

08/01/05-08/02/2005 – The Department of Health and Human Services' (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) will meet on Monday, August 1, 2005, from 8:30 a.m. to 5:00 p.m. EST, and on Tuesday, August 2, 2005, from 8:30 a.m. to 4:00 p.m. EST, at the Radisson Hotel Old Town, 901 North Fairfax Street, Alexandria, Virginia. The meeting will held in the Jefferson Room. The SACHRP August meeting agenda is posted at:
http://www.hhs.gov/ohrp/sachrp/mtgings/mtg08-05/meetingagenda.pdf.

To view the Federal Register Notice containing additional information for this meeting, go to the URL listed below, put in page number 38683, and click Submit.
http://www.gpoaccess.gov/fr/retrieve.html

07/21/05 – International Compilation of Human Subject Research Protections Now Available. Recognizing the continued growth of international research, the Office for Human Research Protections has developed an International Compilation of Human Subject Research Protections. The Compilation lists the laws, regulations, and guidelines of over 50 countries where DHHS funded or supported research is conducted.

The Compilation provides direct web links to each country's Key Organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers, and others to meet regulatory requirements to assure that research studies comply with applicable law.

The Compilation can be accessed on the OHRP website: http://www.hhs.gov/ohrp/international/index.html#NatlPol. To use the Compilation, go to page 3 and then click on the country of interest.

06/15/05 – New OHRP Outreach Campaign. OHRP announces the launch of a new public education campaign, Taking Part in Research: It's Your Decision, to provide information about issues to consider when thinking about participating in clinical trials and other research studies. The centerpiece of the campaign is a one-page pamphlet that guides readers through a series of questions to consider, as they discuss the option of participating in research with their health-care provider, family members and others. OHRP has distributed copies of the pamphlet to some 6,000 research institutions throughout the country, in order to gain broader access to local communities. Bulk copies (up to 300 per requestor) are available free by calling 800-444-6472. A copy of the pamphlet, along with related information, is available at http://www.hhs.gov/ohrp/outreach/ The pamphlet can be downloaded and reproduced locally.

06/13/05 – Guidance on Reporting Incidents to OHRP. The Office for Human Research Protections (OHRP) has issued guidance on procedures institutions may use to file incident reports with OHRP. Incident reports include reports of unanticipated problems involving risks to subjects or others; serious or continuing noncompliance with Department of Health and Human Services (HHS) regulations at 45 CFR part 46 or the requirements or determinations of the institutional review board (IRB); and suspension or termination of IRB approval. In particular, OHRP offers guidance on the following topics: (1) Applicability of incident reporting requirements; (2) information to be included in incident reports; (3) time frame for reporting incidents; (4) OHRP focus on corrective actions when reviewing incident reports; and (5) OHRP's response to incident reports. This guidance can be found at:
http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html
http://www.hhs.gov/ohrp/policy/procedures_for_reporting_052505.pdf

06/13/05 – Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") review process. The Office for Human Research Protections (OHRP) has issued guidance on the HHS 45 CFR 46.407 review process required under subpart D of the HHS Protection of Human Subjects Regulations at 45 CFR part 46. In particular, OHRP offers guidance on the following topics: (1) IRB findings necessary to submit a protocol to OHRP for 407 consideration and/or review; (2) steps in the submission process; (3) OHRP's response to submissions; (4) the schedule and details for 407 panel review; and (5) potential outcomes of the 407 review process. This guidance, which applies to HHS- conducted or -supported research, can be found at:
http://www.hhs.gov/ohrp/children/guidance_407process.html
http://www.hhs.gov/ohrp/children/Guidance_407Process.pdf

03/25/05 – FDA Issues Draft Guidance on Centralized IRBs. The FDA released draft guidance on "Using a Centralized IRB Process in Multicenter Clinical Trials" on March 25. The 10-page guidance which applies to clinical trials conducted under 21 CFR 312, is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0103-gdl0001.pdf.

03/21/05 – On March 21, 2005, the Food and Drug Administration will hold a Part 15 public hearing on reporting of adverse events to institutional review boards. For more information regarding this hearing, including instructions for participating in the hearing and submitting comments to the FDA, please see the Federal Register notice posted at http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2300.pdf.

10/26/04 – The Office for Human Research Protections (OHRP) has updated the set of Human Subject Regulations Decision Charts available at http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm. The revised decision charts provide graphic aids to assist institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. The charts address decisions on the following:

• whether an activity is research that must be reviewed by an IRB
• whether the review may be performed by expedited procedures, and
• whether informed consent or its documentation may be waived.

10/07/04 – Vanderbilt University becomes the 15th organization to achieve AAHRPP® Accreditation.

09/02/04 – Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct: http://www.fda.gov/cber/gdlns/clinholdinvest.pdf

08/30/04 – Guidance on Research Involving Coded Private Information or Biological Specimens: http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf

07/07/04 – Proposed IRB Registration Requirements: The Office for Human Research Protections (OHRP) is proposing to require registration of institutional review boards (IRBs) that review human subjects research conducted or supported by the Department of Health and Human Services (HHS) and that are designated under an assurance of compliance approved for federalwide use by OHRP. The proposed registration requirements will make it easier for OHRP to convey information to IRBs and will support the current IRB registration system operated by OHRP.

Under the current OHRP IRB registration system, the submission of certain information is required by the existing HHS human subjects protection regulations, and certain other information may be submitted voluntarily. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with the proposed IRB registration requirements of the Food and Drug Administration (FDA), and creating a single HHS IRB registration system. FDA simultaneously is publishing a proposed rule regarding FDA IRB registration requirements.

Comments on the OHRP notice must be received on or before October 4, 2004. That notice can be accessed as a pdf document at http://www.hhs.gov/ohrp/news/irbnotice.pdf

Please note that the correct URL for viewing the current IRB registration form is http://www.hhs.gov/ohrp/humansubjects/assurance/regirb.htm

01/27/04 – FDA published a Notice of Availability announcing the availability of a draft guidance entitled "Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions". FDA is revising its March 2002 guidance for industry of the same title to include guidance for sponsors who will be submitting information required by the Best Pharmaceuticals for Children Act. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments for Docket No. 2004D-0014 must be submitted by March 29, 2004.

11/21/03 – Representative Diana DeGette (D-Co) introduced a bill (H.R. 4697) regarding the protection of human subjects in research. On that date, the legislation was referred to the House of Committee on Energy and Commerce.

09/25/03 – NIH publishes a revision HIPAA guidance document for IRBs.

08/11/03 – OHRP updates guidance on expedited review procedures.

04/14/03 – The Privacy Rule, HIPAA, became enforceable by OCR (Office of Civil Rights) as of April 14, 2003.

The regulation
More information on the Privacy Rule
FAQs about HIPAA

HUMAN RESEARCH PROTECTION:

02/25/07-02/27/07 –The third annual accreditation conference was held in Baltimore, Maryland. Over 500 individuals from government, industry, voluntary health agencies, universities, hospitals, independent IRBs, and other research settings were among the participants.

02/26/06-02/28/06 – AAHRPP conference in Phoenix, AZ. To learn more visit http://003aa8c.netsolhost.com/aahrpp2006/general.asp.

09/21/05 – AAHRPP accredits three more organizations: Three universities become the first in their states to win accreditation for way they protect research participants: University of Pittsburgh, Pittsburgh, Pennsylvania The University of South Dakota, Vermillion, South Dakota & University of California, Irvine, Irvine, California.

04/18/05-04/19/05 – The Department of Health and Human Services' (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) met at the Sheraton Four Points Hotel, 1201 K Street, N.W., Washington, D.C. The SACHRP meeting agenda is posted at: http://www.hhs.gov/ohrp/sachrp/mtgings/mtg04-05/agenda4.pdf

07/30/04 – Copernicus Group IRB was awarded Full Accreditation of our Human Research Protection Program (HRPP) by AAHRPP®, The Association for the Accreditation of Human Research Protection Programs, Inc. We are excited to receive recognition for our program designed to protect human research subjects.

07/26/04-07/27/04 – The Department of Health and Human Services' (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) will meet on Monday, July 26, 2004, from 8:30 a.m. to 5:00 p.m. EST, and on Tuesday, July 27, 2004, from 8:30 a.m. to 4:00 p.m. EST, at the Sheraton Four Points Hotel, 1201 K Street, N.W., Washington, D.C.

For further information, please see the Federal Register announcement: http://www.gpoaccess.gov/fr/retrieve.html and type in page 35348, then click SUBMIT.

The SACHRP July meeting agenda is posted at: http://www.hhs.gov/ohrp/sachrp/mtgings/mtg07-04/agenda0704.pdf.

01/15/04 – PHRP announces first accreditation.

01/07/04 – AAHRPP accredits community hospital in New Hampshire.

12/02/03 – First Federal Research Labs to Seek AAHRPP Accreditation.

10/13/03 – AAHRPP Accredits Health Care System's Research Arm.

08/25/03 – AAHRPP accredits VA Medical Center.

07/22/03 – The Secretary's Advisory Committee on Human Research Protections (SACHRP) conducted its inaugural meeting. The SACHRP committee has committed to building on the work that was done by the National Human Research Protections Advisory Committee (NHRPAC) during the Clinton administration.

06/06/03 – AAHRPP announces accredited organization.

05/01/03 – AAHRPP announces first accredited organizations.

03/31/03 – TEN HUMAN RESEARCH ORGANIZATIONS SIGN UP FOR PHRP ACCREDITATION.

Information on AAHRPP’s Accreditation Program
Information on PHRP’s Accreditation Program