The next meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP) will take place December 11-12, 2003, from 8:30 a.m - 5:00 p.m in Downtown Washington, DC at the Four Points Sheraton Hotel, Franklin Ballroom, 1201 K Street, N.W., Washington, DC 20005 (just 2 blocks from the McPherson Square Metro (Blue/Orange Line)).
On December 11, SACHRP will receive and discuss preliminary reports from its three subcommittees that were created by SACHRP at its July 22, 2003 meeting to address issues related to the following three topics areas: Department of Health and Human Services (HHS) regulations and policies for research involving prisoners, HHS regulations and policies for research involving children, and the accreditation of human research protection programs by non-federal accrediting bodies. On December 12, SACHRP will hold panel discussions related to human subjects research in international settings and adverse event reporting requirements under Department of Health and Human Services and Food and Drug Administration regulations. The committee will also discuss future tasks for 2004. Members of the public will have the opportunity to provide comments at the meeting on December 11 and 12, 2003. Public comment will be limited to five minutes per speaker.
November 4, 2003
As previously stated in a newsflash in February 2001, existing Multiple Project Assurances (MPA) and Cooperative Project Assurances (CPA) will remain in effect until further notice. In addition, OHRP will continue to accept Single Project Assurances (SPA) until further notice. This action is pending final clearance of the Federalwide Assurance (FWA). The FWA was made available initially in December 2000 as a new Assurance of Compliance, and it is expected to replace all other types of assurances in the future. OHRP encourages institutions to begin submitting the FWA voluntarily. As a part of the FWA application, the institution must designate their reviewing Institutional Review Board(s) (IRB). All IRBs designated on an FWA must be registered with OHRP. You will find the FWA Terms of Assurance, application, and instructions on this website; the IRB registration form and instructions at Forms ; and information on the submission of an SPA, CPA, and MPA at Forms.
October 29, 2003
The Office for Human Research Protections (OHRP) has reorganized its structure to reflect an evolving range of activities. The changes are administrative and do not affect OHRP's mission, emphasis or activities. Broadly, the functions of the former Division of Assurances and Quality Improvement have been reassigned to two other divisions: Assurances are now part of the newly named Division of Policy and Assurances, and Quality Improvement is now part of the Division of Education and Development.
In the Division of Policy and Assurances, Julie Kaneshiro is the Team Leader for Policy, and Jan Walden is the Team Leader for Assurances. In the Division of Education and Development, Yvonne Higgins is the Team Leader for Quality Improvement.
Division Directors remain unchanged – Kristina Borror, Division of Compliance Oversight; Shirley Hicks, Division of Education and Development; and Irene Stith-Coleman, Division of Policy and Assurances.
All other OHRP functions remain the same.
For further details, please see the Federal Register notice, published on October 22, 2003, at [PDF Document] .
September 25, 2003
Save the date for an upcoming OHRP Research Community Forum "Protecting Human Subjects in Social, Behavioral, and Educational Research," sponsored by Western Kentucky University in Bowling Green, Kentucky on October 29, 2003. For program information see the brochure at http://www.aascu.org/ofpopen.
September 25, 2003
Save the date for an upcoming OHRP Research Community Forum "Contemporary Issues in Human Research Protections," sponsored by Iowa Health - Des Moines in Des Moines, Iowa on November 17, 2003. For program information see the brochure at http://www.iowahealth.org/body.cfm?id=354.
September 23, 2003
The Office for Human Research Protections (OHRP) has updated its guidance on Expedited Review Procedures. You can find the revised guidance document, Guidance on the Use of Expedited Review Procedures. The revised document consolidates guidance regarding expedited review found in two earlier guidance documents:
- Expedited Review of Certain Research by Institutional Review Boards (OPRR Reports, January 6, 1999) and
- Exempt Research and Research That May Undergo Expedited Review (OPRR REPORTS, May 5, 1995)
August 13, 2003
When OHRP receives a Federalwide Assurance (FWA) from an institution holding a Multiple Project Assurance (MPA), OHRP deactivates the MPA for that institution once the FWA is reviewed and approved. OHRP would like to inform all institutions with an active MPA that OHRP will approve an FWA to replace the MPA only if:
- the MPA institution has submitted a completed IRB/IEC Registration form (see below), and
- appropriate arrangements have been made to ensure that all affiliated and co-signatory institutions covered by the MPA remain covered by an applicable OHRP-approved Assurance (in some cases, this may involve allowing the existing MPA to remain in effect for any co-signatory institutions covered by the MPA that are not seeking approval for their own FWA). Therefore, if you elect to replace your MPA with an FWA, please ensure that these processes are completed before filing the FWA.
MPA institutions were grandparented into the IRB/IEC Registration system on 12/04/2000 and assigned IRB Organization (IORG) numbers and each IRB was assigned a unique IRB identifier. Some MPA institutions have subsequently completed their IRB Registration form; however, most have not. If you are an MPA institution filing an FWA and you have not completed an IRB Registration form, you should submit it manually (i.e., a fax or paper submission) using the current version of the form provided at the OHRP web page.
August 13, 2003
Register NOW for the OHRP/FDA/DVA National Human Subject Protections Workshop "Today's Research, Tomorrow's Issues," sponsored by Friends Research Institute, University of California at San Francisco, and Charles R. Drew University of Medicine and Science in San Francisco, California on September 23-24, 2003. For registration & program see brochure at: http://www.friendsresearch.org/ohrp_summary.htm.
August 8, 2003)
The OHRP Videotape Series "Protecting Human Subjects" is once again available. Individuals who sent in a requested for a videotape during the past 10 months should be receiving it within the next few weeks. If the videotape is not received in the next few weeks please send OHRP a new request. See the ordering instructions.
August 7, 2003
Register NOW for the first OHRP/ORI jointly sponsored workshop, being held September 7-9, 2003, in New York City. The Columbia University in New York City is hosting “Respect For All Involved: A National Research Integrity & Human Subjects Protection Workshop.” This workshop will address current issues related to the responsible conduct of research and human research protections. For agenda and registration see: http://cpmcnet.columbia.edu/dept/cme/Med-104-03/Med-104.html.
August 4, 2003 Electronic Registration of IRB/IEC The Office for Human Research Protections (OHRP) has introduced a process for electronic submission of Institutional Review Board (IEC) or Independent Ethics Committee (IEC) Registrations (for new filings only).
Electronic submission of your new IRB/IEC Registration will expedite processing of the registrations by OHRP. With the electronic submission process, notification of registration occurs by e-mail automatically as soon as OHRP processes your submission. Therefore, OHRP encourages institutions to submit their IRB/IEC Registration electronically rather than by Fax, mail, or hand delivery.
The electronic form cannot be used at this time to update or renew existing IRB Registrations or if your institution has been assigned an IORG Number by OHRP (this includes all MPA institutions). In the future, you will be able to electronically submit an update or renewal of an existing IRB/IEC Registration.
You may access the new electronic submission process for the IRB/IRC Registration at: http://ohrp.cit.nih.gov/efile/. Updated instructions for completing the registration form may be accessed at: http://www.hhs.gov/ohrp/humansubjects/assurance/regirbi.htm.
July 16, 2003
The Office for Human Research Protections (OHRP) is soliciting public review and comment on a proposed research protocol entitled "HIV Replication and Thymopoiesis in Adolescents," as announced in Federal Register Vol. 68, No. 136, page 42061-42062, dated July 16, 2003, available at http://www.hhs.gov/ohrp/references/fr07-16.pdf [PDF Document] . This proposed research would include children as research subjects. Experts in relevant disciplines have reviewed this protocol pursuant to Department of Health and Human Services (HHS) regulations at 45 CFR 46.407. Following public review and comment, the Secretary of HHS will make a final determination on whether HHS may support this research. Materials regarding this proposed research protocol are available for review on the OHRP website at http://www.hhs.gov/ohrp/panels/407-04pnl/pindex.htm. To be considered, comments must be received on or before 4:30 PM EST, September 2, 2003. Written comments should be submitted to Ms. Kelley Booher, Division of Policy, Planning, and Special Projects, OHRP, 1101 Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852. Comments may also be submitted via facsimile at 301-402-2071 or via to email to to email, click 407panel04@osophs.dhhs.gov.
July 15, 2003 OHRP/FDA/DVA National Human Subject Protections Workshop "Today's Research, Tomorrow's Issues," sponsored by Friends Research Institute, University of California at San Francisco, and Charles R. Drew University of Medicine and Science in San Francisco, California on September 23-24, 2003. For registration & program see brochure at http://www.friendsresearch.org/ohrp_summary.htm.
July 10, 2003 OHRP/ORI/FDA/DVA National Research Integrity & Human Subjects Protection Workshop "Respect For All Involved," sponsored by Columbia University and City University of New York in New York, NY on September 7-9, 2003. For registration & program see brochure at: http://columbiacme.org/OHR-03/SAVE_THE_DATE_Final.pdf [PDF Document] .
July 3rd, 2003 The inaugural meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will be held on Tuesday, July 22, 2003 and open to the public, as announced in Federal Register Vol 68, No. 128, page 39953, dated July 3, 2003, available at http://www.hhs.gov/ohrp/references/fr07-03.pdf [PDF Document] . The meeting will convene EDT from approximately 8:30 a.m. to 5:00 p.m. and held at the Hubert H. Humphrey Building, Room 800 located at 200 Independence Avenue, SW, Washington, D.C., 20201. YOU MUST HAVE A PHOTO ID FOR ENTRY INTO THE BUILDING. At this inaugural meeting, SACHRP will review the activities which were not completed by the former National Human Research Protections Advisory Committee before its charter expired and begin to plan and prioritize its activities for the next 24 months.
Information about SACHRP and the draft meeting agenda will be posted on the SACHRP website at: http://www.hhs.gov/ohrp/sachrp/sachrp.htm
June 20th, 2003
The Secretary of Health and Human Services (DHHS), pursuant to 45 CFR 46.101(i), has waived the applicability of certain provisions of subpart C of 45 CFR part 46 (Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects) to specific types of epidemiological research involving prisoners as subjects. This waiver, effective June 20, 2003, will allow DHHS to conduct or support certain important and necessary epidemiological research that would not otherwise be permitted under subpart C.
The Secretary of HHS has waived the applicability of 45 CFR 46.305(a)(1) and 46.306(a)(2) for certain epidemiologic research conducted or supported by DHHS
- in which the sole purposes are:
- to describe the prevalence or incidence of a disease by identifying all cases, or
- to study potential risk factor associations for a disease,
and
- where the institution responsible for the conduct of the research certifies to the Office for Human Research Protections, acting on behalf of the Secretary, that: the institutional review board (IRB) approved the research and fulfilled its duties under 45 CFR 46.305(a)(2)-(7) and determined and documented that
- the research presents no more than minimal risk and no more than inconvenience to the prisoner-subjects, and
- prisoners are not a particular focus of the research,
The waiver can be accessed at http://www.hhs.gov/ohrp/references/fr06-20.pdf [PDF Document].
For further information, contact the OHRP Prisoner Research Contact Person at (301) 496-7005 (phone); (301) 402-0527(fax).
June 13, 2003
The Office for Human Research Protections (OHRP) is soliciting public review and comment on a proposed research protocol entitled "Sleep Mechanisms in Children: Role of Metabolism," as announced in Federal Register Vol. 68, No. 114, pages 35415-6, dated June 13, 2003, available at http://www.hhs.gov/ohrp/references/fr06-13h.pdf [PDF Document]. This proposed research would include adolescent children as research subjects. Experts in relevant disciplines have reviewed this protocol pursuant to Department of Health and Human Services (HHS) regulations at 45 CFR 46.407. Following public review and comment, the Secretary of HHS will make a final determination on whether HHS may support this research protocol. Materials are available for review on the OHRP website at http://www.hhs.gov/ohrp/panels/407-03pnl/pindex.htm. To be considered, comments on this proposed research protocol must be received on or before 4:30 PM EST, July 28th, 2003. Written comments should be submitted to Ms. Kelley Booher, Division of Policy, Planning, and Special Projects, OHRP, 1101 Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852. Comments may also be submitted via facsimile at 301-402-2071 or to email, click 407panel03@osophs.dhhs.gov.
June 13, 2003
The Office for Human Research Protections (OHRP) is soliciting public review and comment on a proposed research protocol entitled "Characterization of Mucus and Mucins in Bronchoalveolar Lavage Fluids from Infants with Cystic Fibrosis," as announced in Federal Register Vol. 68, No. 114, pages 35414-5, dated June 13, 2003, available at http://www.hhs.gov/ohrp/references/fr06-13n.pdf [PDF Document] . This proposed research would include children as research subjects. Experts in relevant disciplines have reviewed this protocol pursuant to Department of Health and Human Services (HHS) regulations at 45 CFR 46.407. Following public review and comment, the Secretary of HHS will make a final determination on whether HHS may support this research. Materials regarding this proposed research protocol are available for review on the OHRP website at http://www.hhs.gov/ohrp/panels/407-02pnl/pindex.htm. To be considered, comments must be received on or before 4:30 PM EST, July 28, 2003. Written comments should be submitted to Ms. Kelley Booher, Division of Policy, Planning, and Special Projects, OHRP, 1101 Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852. Comments may also be submitted via facsimile at 301-402-2071 or to email, click 407panel02@osophs.dhhs.gov.
May 27, 2003
The Office for Human Research Protections (OHRP) has posted the following guidance document on this website: “OHRP Guidance on the Involvement of Prisoners in Research” (May 23, 2003). Click here http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm. The new document replaces the prisoner research guidance document titled “OPRR Guidance on Approving Research Involving Prisoners " (May 19, 2000). The new guidance document has been updated for format. It also provides additional guidance on the responsibilities required of IRBs and institutions under 45 CFR 46 subpart C.
May 5, 2003
OHRP/DVA National Human Subject Protections Workshop "Protecting Human Subjects in the 21st Century: Issues in Social & Behavioral Research", sponsored by University of Georgia @ Athens and Spelman University @ Athens in Athens, GA on July 28-30, 2003. For registration & program see brochure at: http://www.gactr.uga.edu/conferences/2003/Jul/28/human.phtml.
April 16, 2003
OHRP/FDA/DVA National Human Subject Protections Workshop "Protecting Human Research Subjects: Theory & Practice", sponsored by Tulane University, Xavier University, and Ochsner Clinic Foundation in New Orleans, LA on June 5-6, 2003. For registration & program see brochure at: http://www.som.tulane.edu/irb/HRSPWSHOP/TheoryPractice.html.
April 14, 2003
The Office for Human Research Protections (OHRP) is soliciting public review and comment on a proposed research protocol entitled "Alcohol, Sleep and Circadian Rhythms in Young Humans, Study 2 - Effects of Evening Ingestion of Alcohol on Sleep, Circadian Phase, and Performance as a Function of Parental History of Alcohol Abuse/Dependence" as announced in Federal Register Vol. 68, No. 71, page 17950, dated April 14, 2003, available at http://www.hhs.gov/ohrp/references/fr04-14.pdf [PDF Document]. This proposed research would include adolescent children as research subjects. Experts in relevant disciplines have reviewed this protocol pursuant to Department of Health and Human Services (HHS) regulations at 45 CFR 46.407. Following public review and comment, the Secretary of HHS will make a final determination on whether HHS may support this research protocol. Materials are available for review on the OHRP website at http://www.hhs.gov/ohrp/panels/407-01pnl/pindex.htm. To be considered, comments on this proposed research protocol must be received on or before May 29, 2003. Written comments should be submitted to Ms. Kelley Booher, Division of Policy, Planning, and Special Projects, OHRP, 1101 Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852. Comments may also be submitted via facsimile at 301-402-2071 or to email, click 407panel01@osophs.dhhs.gov.
April 2, 2003
HHS Secretary Tommy G. Thompson has proposed draft guidance for protecting research volunteers from possible harm caused by financial conflicts of interest in research. HHS is soliciting public comment on the draft guidance document for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties, entitled "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection" as announced in Federal Register, Vol.68, No. 61, Monday March 31, 2003, Page 15456. The notice can be accessed as a pdf document at: http://www.hhs.gov/ohrp/references/fr03-7691.pdf. [PDF Document]
This draft guidance raises points to consider in determining whether specific financial interests in research that might affect the rights and welfare of human subjects, and if so, what actions could be considered to protect those subjects. The draft guidance presents a single HHS-wide reference for decision-making that would apply to all human subject research conducted or supported by HHS and its agencies, including the National Institutes of Health and the Centers for Disease Control and Prevention, which are overseen by HHS' Office for Human Research Protections (OHRP). It would also apply to all human subject research regulated by the Food and Drug Administration (FDA).
Comments on the draft guidance document (Docket No. 02N-0475) must be received on or before May 30, 2003 and should be submitted to: http://www.fda.gov/dockets/ecomments. Received comments may be viewed on the FDA website at: http://www.fda.gov/ohrms/dockets/default.htm.
March 13, 2003
The Office for Human Research Protections (OHRP) is continuing the process of updating its web site guidance materials by developing new guidance documents. In addition, outdated documents posted on the “Guidance Topics by Subject” page (at http://www.hhs.gov/ohrp/g-topics.htm) and the “OPRR Reports ‘Dear Colleague Letter’” page (at http://www.hhs.gov/ohrp/dearcoll.htm) are being replaced by updated guidance documents.
As new and updated documents are posted on the “Guidance Topics by Subject” page, they are marked with a flashing icon. A heading on each updated guidance document will indicate that it has replaced an outdated guidance document, state the reasons for the changes, and provide a link to the outdated version.
Many of the documents listed on the "Guidance Topics by Subject” page are also found on the "OPRR Reports ‘Dear Colleague Letter’" page. On the “OPRR Reports” page, the outdated documents will remain listed , but they will be flagged with the word "Archived."
The outdated documents are being placed on a recently created “Archived Documents” page (at hhttp://www.hhs.gov/ohrp/archive.htm), where they will be available FOR HISTORICAL REFERENCE PURPOSES ONLY. Furthermore, some outdated documents being archived will not be replaced. In all cases, the archived documents are NOT to be considered as either current or appropriate guidance. A heading on each archived document will either
- state that the guidance document has been replaced and provide a link to the updated guidance document or
- state that the document has not been replaced and provide the reasons why it is not being replaced.
OHRP welcomes any suggestions or comments that you may have about our website. Please send them to lniemoeller@osophs.dhhs.gov.
March 13, 2003
OHRP/FDA Research Community Forum entitled, "An Integrated Approach to Patient Protection: Aligning Regulatory, Industry and Investigator Interests," sponsored by Main Line Health Heart Center in Philadelphia, PA on April 25, 2003. For registration & program see brochure at http://www.hhs.gov/ohrp//references/broch403.pdf [PDF Format].
March 12, 2003
OHRP/FDA/DVA National Human Subjects Protections Workshop: "Protecting Human Research Subjects: Theory and Practice," sponsored by Tulane University Health Sciences Center, Xavier University of Louisiana, and Ochsner Clinic Foundation on June 4-6, 2003 in New Orleans, LA. For registration & program information see brochure at http://www.som.tulane.edu/irb/Workshop.PDF [PDF Document].
February 5, 2003
OHRP/FDA/DVA National Human Subjects Protections Workshop: "The Future Face of Protecting Human Subjects: Legislation & Implementation," sponsored by Lahey Clinic & Harvard Medical School on April 7 & 8, 2003 in Burlington, MA. For registration & program see brochure at http://www.lahey.org/PDF/Research/OHRPRetreat2003.pdf [PDF Document].
January 31, 2003
HHS Secretary Tommy G. Thompson today named Bernard A. Schwetz, D.V.M, Ph.D, to be acting director of the HHS Office for Human Research Protections (OHRP). For further details, see http://www.hhs.gov/news/press/2003pres/20030131a.html.
January 24, 2003
Testing of diluted Dryvax® smallpox vaccine in children will not take place, as had been proposed last year (see Federal Register Vol. 67, No. 211, Thursday October 31, 2002, Page 66403; available for review on the Office for Human Research Protections [OHRP] website at http://www.hhs.gov/ohrp/dpanel/fr1031.pdf [PDF Document]. Smallpox preparedness plans have evolved since the study was proposed, and current plans do not call for use of diluted Dryvax® vaccine in children. In the absence of such plans, the Secretary, Department of Heath and Human Services (HHS), and the Commissioner, Food and Drug Administration (FDA), have determined that there is no justification for this particular clinical investigation to proceed. The joint letter from OHRP and FDA to the institution that had referred this clinical investigation for review pursuant to HHS regulations at 45 CFR 46.407 and FDA regulations at 21 CFR 50.54 is available at http://www.hhs.gov/ohrp/dpanel/dpindex.htm (see final item on list) .
December 18, 2002
The Office for Human Research Protections (OHRP) is reopening the period for public comment and is making available additional information regarding the protocol entitled “Precursors to Diabetes in Japanese American Youth” as announced in Federal Register Vol.67, No. 243, Wednesday, December 18, 2002, Pages 77495-77496, available on the OHRP website at: http://www.hhs.gov/ohrp/pdjay/frpdjay.pdf [PDF Format]. On August 7, 2002, OHRP gave notice (67 FR 51283-51284) that it was proposing to recommend approval of Department of Health and Human Services (DHHS) support for the above-cited protocol, subject to a stipulation that certain modifications be made to the protocol and consent forms. Materials are available for review on the OHRP website at: http://www.hhs.gov/ohrp/pdjay/pdjayindex.htm A paper copy of the referenced materials is available upon request. Public comment may be sent via facsimile at (301) 402-2071 (not a toll free number) or by e-mail to: kbooher@osophs.dhhs.gov or (301) 435-5654.
December 9, 2002
The Office for Human Research Protections (OHRP) has introduced a process for electronic submission of the Federalwide Assurance (FWA) for new filings only. In the near future, you will also be able to electronically submit registration of your institutional review board (IRB) or independent ethics committee (IEC), as well as update an already approved FWA or a registered IRB/IEC.
Electronic submission of the FWA will expedite processing of the assurance by OHRP. With the electronic submission process, notification of approval occurs by e-mail automatically as soon as OHRP approves your submission. Therefore, OHRP encourages institutions to submit the FWA electronically rather than by mail.
You may access the new electronic submission process for the FWA at: http://ohrp.cit.nih.gov/efile/.
October 31, 2002
The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are soliciting public review and comment on a proposed research protocol entitled "A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age" as announced in Federal Register Vol. 67, No. 211 Thursday October 31, 2002 Page 66403, available for review on the OHRP website at: http://www.hhs.gov/ohrp/dpanel/fr1031.pdf. This proposed research would include children as research subjects. Experts in relevant disciplines have reviewed the protocol, but prior to the Secretary, HHS, and Commissioner, FDA, making a final determination on whether this clinical investigation may proceed, public review and comment are hereby solicited pursuant to HHS regulations at 45 CFR 46.407 and FDA regulations at 21 CFR 50.54. Materials are available for review on the OHRP website at: http://www.hhs.gov/ohrp/dpanel/dpindex.htm. Public comment on the proposed research protocol should be submitted to: http://www.fda.gov/dockets/ecomments. Received comments may be viewed on the FDA website at: http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n0466.htm.
October 16, 2002
After more than two years at the helm, Dr. Greg Koski, Director, Office for Human Research Protections, has decided that it is time to return to private life. Dr. Koski will return to Harvard University, effective November 30, 2002. If you have any questions or require additional information, you may contact Ms. Patricia El-Hinnawy at pel-hinnawy@osophs.dhhs.gov or (301) 435-5654.
October 7, 2002
The Department of Health and Human Services (DHHS) is proposing to waive the applicability of certain provisions of Subpart C of 45 CFR Part 46 (Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects) to specific types of epidemiological research involving prisoners as subjects. Such a waiver would allow DHHS to conduct or support certain important and necessary epidemiologic research that presents no more than minimal risk and no more than inconvenience to prisoner subjects. Comments on the notice must be received on or before November 6, 2002. The notice can be accessed as a pdf document at: http://www.hhs.gov/ohrp/references/hr100702.pdf [PDF Document] until such time as the Federal Register assigns a permanent URL. OHRP will announce the permanent URL in a Newsflash update.
September 17, 2002
The Office for Human Research Protections has posted the recently approved Office of Management and Budget (OMB) form entitled "Protection of Human Subjects: Assurance Identification/Certification/Declaration of Exemption," which is a sample format that will be used by some entities to comply with the reporting requirements of the common rule for the protection of human research subjects (56 FR 28003) and the Public Health Service regulations at 45 CFR Part 46. This replaces the Form 310, used previously. You may download the form at: http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf [Rich Text Format].
September 12, 2002
Dr. Greg Koski, Director, Office for Human Research Protections (OHRP) has sent an open letter to the research community reaffirming his invitation to participate in OHRP's quality improvement program as well as announcing the expansion of the office's not-for-cause surveillance evaluations by the Division of Compliance Oversight and describing the relationship of these evaluations to the quality improvement consultations conducted by the Division of Assurances and Quality Improvement. You may access this letter at: http://www.hhs.gov/ohrp/references/oltr2.pdf [PDF Document].
August 26, 2002
The Boys Town National Research Hospital and the Office for Human Research Protections (OHRP) are jointly sponsoring a conference in Omaha, Nebraska on September 17, 2002 entitled, "Current Human Research Issues and Solutions: Regulatory Update and Hot Topics." Program information can be found at: (http://www.hhs.gov/ohrp/references/boys.pdf [PDF Document].
August 14, 2002
Registration information regarding the new education workshop, "Human Research Protections: Current Issues and Solutions" - Co-Sponsored by OHRP, ORCA/DVA, and University of Oklahoma Health Sciences Center to be held in Oklahoma City, Oklahoma on September 18-20, 2002 may be found at: http://www.ouhsc.edu/hrp/. Information regarding other future workshops can be found at http://www.hhs.gov/ohrp/wrkshp.htm.
August 9, 2002
The Office for Human Research Protections (OHRP) is proposing to recommend HHS support of a research protocol entitled "Precursors to Diabetes in Japanese American Youth" published on August 7, 2002 (67 FR 51283-51284). This proposed research would include children as research subjects. OHRP has reviewed the protocol and findings of an expert panel and proposes to recommend approval for HHS support of this research protocol. Public comment on proposed recommendation must be received on or before August 21, 2002. A copy of the Federal Register notice (PDF Format), may be viewed at: http://www.hhs.gov/ohrp/references/youth.pdf. [PDF Document]
July 22, 2002
The INVESTIGATOR 101 CD-ROM package now contains a Continuing Medical Education Test and a Participant Evaluation Form. Participants may earn up to four (4) Category I Credits by reviewing this CD-ROM in depth, correctly answering at least 70% of the accompanying examination questions, and submitting the completed examination and evaluation to Boston University School of Medicine with a fee of $40. The development of these new materials has resulted in shipment delays. OHRP apologizes for the delay in the distribution of the INVESTIGATOR 101 CD-ROM. Please allow four to six weeks for processing your request. To find more information about the INVESTIGATOR 101 CD-ROM package/program, visit the OHRP website at: http://www.hhs.gov/ohrp/references/cdrom.pdf. [PDF Document]
Institutions who have received the CD-ROM will be mailed a copy of the examination and evaluation. Institutions that have technical problems with their CD-ROM should send their defective CD-ROM along with a letter stating their technical difficulties to: Ms. Gail Carter, Program Assistant, Division of Education and Development, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Please allow four to six weeks for processing replacement CD-ROMs.
July 12, 2002
The Office for Human Research Protections (OHRP) has posted the following two guidance documents on the OHRP website:
- “Guidance on Continuing Review”; and
- “Guidance on Written IRB Procedures.”
OHRP’s guidance on continuing review dated July 11, 2002 can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/contrev2002.htm. This document expands on and replaces three of OHRP’s prior guidance documents on this topic:
- "Continuing Review--Institutional and Institutional Review Board Responsibilities" (January 10, 1995);
- "IRB Approval Periods and Continuing Review of Research" (January 20, 2000); and
- "Continuing Review of DSMB-Monitored Clinical Trials" (May 22, 2000). This new guidance was developed to assist IRBs, investigators, research institutions and sponsors to implement the requirement for continuing review of human subjects research by an Institutional Review Board (IRB).
OHRP’s guidance on written IRB procedures dated July 11, 2002 can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/irbgd702.htm. This document updates OHRP’s April 2, 2002 guidance entitled, “OHRP Guidance on Written IRB Procedures.” This guidance has been updated to reflect OHRP’s July 11, 2002 guidance on continuing review. In addition, minor changes were made to the section of the April 2, 2002 guidance that addressed IRB review in emergency situations, and the section regarding the inclusion of women and minorities in research was deleted since it was not directly related to the requirements for written IRB procedures under the Department of Health and Human Services regulations at 45 CFR Part 46.
June 17, 2002
Streaming videos of the presentations from the OHRP/USC National Human Subject Protections Education Workshop "Informed Consent, Cultural Values, And Regulatory Overview: A Closer Look At Behavioral Issues In Biomedical And Social Science Research" July 16-17, 2001 are available at the USC website: http://www.usc.edu/dept/socialworkhttp://www.hhs.gov/ohrp/videos.html .
May 14, 2002
Assurance listings previously posted on this website have been replaced by an interactive assurance search screen. Links to the old listings have been replaced with a link to the assurance search screen. The assurance search screen provides dynamic search capabilities - providing quicker information retrieval and additional detailed information that could not be displayed/printed in a table format. It also reduces the size of downloaded web pages to facilitate telecommunications for our web visitors using dial-up modems.
May 13, 2002
OHRP recently posted details regarding its Quality Improvement Program, including the QA-Self Assessment Tool on its website at: http://www.hhs.gov/ohrp/humansubjects/qip/qip.htm. A copy of the Federal Register notice announcing the tool and a public comment period on the tool is also posted. OHRP will not collect the tool until OMB approves collection of this information.
The Division of Assurances and Quality Improvement (DAQI) is currently scheduling QI interactions with institutions. DAQI has received a significant positive response to the open invitation letter from Dr. Greg Koski.
May 13, 2002
Health Improvement Institute (HII), a private, not for profit corporation based in Bethesda, MD, is formulating criteria for a new national "Award for Excellence in Human Research Protection." HII is developing this awards program under a contract from the Department of Health and Human Services' Office for Human Research Protections. Under the program, an independent, non-governmental board will select awardees to recognize excellence in their programs for protection of human research participants.
To learn more about the awards program, download participation forms from the program website at http://www.hii.org , or send an email to hii@mcman.com.
April 30, 2002
"The Federal Register notice announcing that the new Federalwide Assurance (FWA) and IRB Registration forms were submitted to the Office of Management and Budget for clearance in compliance with the Paperwork Reduction Act of 1995 was released on April 19, 2002. These are the same versions of the forms posted on this website on March 20, 2002. The new FWA and IRB Registration forms are open for public comment for 30 days from the date of the notice. You may view the notice at: (http://www.hhs.gov/ohrp/references/fwanotc.pdf [PDF Document].
April 25, 2002
The University of California, San Francisco and the Office for Human Research Protections (OHRP) are sponsoring a Town Meeting in San Francisco, CA on May 6, 2002 entitled "Regulatory Overview and Hot Topics: It's Your Turn to Ask the Feds". Program information can be found at: (http://www.hhs.gov/ohrp/references/sfwrkshp.pdf [PDF Document].
April 17, 2002
Dr. Greg Koski, Director, Office for Human Research Protections (OHRP) has sent an open invitation to the research community. You may access this letter at: (http://www.hhs.gov/ohrp/references/oltr.pdf [PDF Document].
April 3, 2002
The Office for Human Research Protections (OHRP) has posted guidance regarding written Institutional Review Board (IRB) procedures. In order to assist institutions in developing adequate written IRB procedures, OHRP has compiled a summary of the relevant regulatory requirements and guidance issued routinely by OHRP over the past several years. This new OHRP guidance, dated April 2, 2002, can be found at (http://www.hhs.gov/ohrp/humansubjects/guidance/wirbproc.pdf [PDF Document].
April 3, 2002
“HHS Proposes Changes to Privacy Rule That Protect Privacy, Access to Care. HHS Secretary Tommy G. Thompson proposes changes to HHS’ health privacy regulations to ensure strong privacy protections while correcting unintended consequences that threatened patients’ access to quality health care. Proposed Modifications to Privacy Rule open for public comment for 30 days, through April 26, 2002.
Please visit http://www.hhs.gov/ocr/hipaa/ to access the press release, fact sheet, and the Privacy Rule NPRM.”
March 29, 2002
The Office for Human Research Protections (OHRP) is aware of the recent questions posted on the IRBForum regarding the new version of the Federalwide Assurance (FWA) that was posted on the OHRP website on March 20, 2002. At this time, we would like to respond to some of these questions. Information regarding the posting of the FWA is available at: (http://www.hhs.gov/ohrp/irbasur.htm). The answers to some specific questions raised on the IRBForum follow:
- Why has OHRP revised the FWA?
OHRP originally placed the FWA on its website in December 2000 for public comment, and has revised the forms in accordance with those comments and to accommodate suggestions made by other Federal Departments and Agencies that support human subjects research.
- Why is OHRP now taking public comment on the FWA? Does this mean that the FWA is still undergoing revisions?
Further public comment is sought in accordance with the Paperwork Reduction Act. Because the forms have been modified in accordance with public comment and to meet concerns raised by other Federal Agencies, OHRP does not anticipate further significant changes to the forms.
- What is the status of FWA's issued up to today's date? Are they effective? What if they do not incorporate items in the revised FWA published today?
FWAs submitted and approved prior to March 21, 2002 will be considered effective by OHRP. Furthermore, FWAs using the December 2000 version submitted to OHRP and pending approval will be processed by OHRP. The new FWA does not change the regulatory requirements nor an institution's commitment to the federal regulations from what was provided in the original FWA.
- Given that OHRP is taking public comment on the FWA, should institutions continue to apply for an FWA or wait until a final FWA is published on the website?
The FWA is posted for public comment. If institutions choose to submit an FWA while comment is being sought and OMB approval is pending, OHRP will accept that submission.
- It would be helpful to those of us in the field who work with investigators on FWA applications for OHRP to post an outline of the differences and changes between the old FWA and the revised FWA.
OHRP is preparing a document that will provide a comparison of the old and new FWA, as well as answers to frequently asked questions, and will provide these on its website in the near future.
March 26, 2002
FDA Seeks Comment on Whether to Require Sponsors and Investigators to Inform Institutional Review Boards (IRBs) of Any Prior IRB Reviews. The Food and Drug Administration (FDA) on Wednesday, March 6 published in the Federal Register an Advance Notice of Proposed Rulemaking seeking information on IRB practices to determine whether to draft a regulation to require sponsors and investigators to inform IRBs about any prior IRB review decisions. According to the Notice "These disclosures could help ensure that sponsors and clinical investigators who submit protocols to more than one IRB will not be able to ignore an unfavorable IRB review decision and that IRBs reviewing a protocol will be aware of what other IRBs reviewing similar protocols have concluded." The DHHS Office of Inspector General recommended this requirement in a 1998 report in an effort to curb "IRB shopping." Comments on the notice are due by June 4, 2002. If, after reviewing comments submitted in response to the Notice, FDA determines that it is appropriate to draft regulations, it would seek additional comment on the draft before issuing any new regulations. The notice is available under the FDA heading at http://www.access.gpo.gov/su_docs/fedreg/a020306c.html
March 21, 2002
The revised Federalwide Assurance (FWA) forms, Terms of Assurance, and IRB Registration form are now posted on this website and will be made available for public comment. The new FWA and IRB Registration forms may be found at: http://www.hhs.gov/ohrp/irbasur.htm.
March 20, 2002
OHRP has updated its November 16, 2001 guidance entitled, "Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles." OHRP's March 19, 2002 guidance can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf [PDF Document].
March 7, 2002
The INVESTIGATOR 101 CD-ROM is a new state-of-the-art media that provides education on the responsible conduct of human research and protection of human subjects. This remarkable educational tool was developed by the Public Responsibility in Medicine and Research (PRIM&R;). It provides a combination of interactive features such as: cross linking, search engines, speakers, slide presentations, transcripts, ethical and research guidelines, and federal regulatory documents. OHRP is announcing the availability of this CD-ROM to institutions having an approved Department of Health and Human Services (DHHS) Assurance on file with the OHRP. Those institutions having either a Federalwide Assurance (FWA) or a Multiple Project Assurance (MPA) will be eligible to receive a copy of the CD-ROM. Please note that all Federally Assured Institutions who request the Investigator 101 CD-ROM [Click for Instructions] [PDF Document] must sign a Recipient License Agreement with the Public Responsibility in Medicine and Research and adhere to the terms and conditions specified in this agreement. Questions regarding this agreement should be directed to Ms. Rebecca Leroux at PRIM&R; (rebecca..leroux@PRIM&R.org; or 617-423-4112). Please allow four to six weeks for processing.
February 27, 2002
A Federal Interactive Teleconference Town Meeting entitled, "Current Human Research Issues and Solutions: Regulatory Overview and Hot Topics," will be held at the University of Illinois, in Chicago, IL, on March 5, 2002. Due to current technical limitations, this teleconference will not be broadcasted over the internet. To view the brochure for this town meeting, Click or visit http://www.hhs.gov/ohrp/references/town.pdf [PDF Document] To view a schedule of upcoming workshops, Click or visit http://www.hhs.gov/ohrp/wrkshp.htm.
December 13, 2001
Revised 45 CFR 46 Subpart B (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) published as Final Rule by the Department of Health and Human Services is effective Today, amending Subpart B of 45 CFR 46. These regulations provide additional protections for pregnant women and human fetuses involved in research. The final rule continues the special protections for pregnant women and human fetuses that have existed since 1975 and makes limited changes in terminology referring to neonates, clarifies provisions for paternal consent when research is conducted involving fetuses, clarifies language that applies to research on newborns of uncertain viability, and corrects technical errors.
November 16, 2001
The Office for Human Research Protections of the Department of Health and Human Services offers the following guidance for Institutional Review Boards (IRBs), investigators and sponsors considering research activities involving human embryonic stem cells (HESCs), HESC-derived test articles, human embryonic germ cells derived from fetal tissue, and/or human embryonic germ cell-derived test-articles at (http://www.hhs.gov/ohrp/references/HESCGuidance.pdf) [PDF Document].
November 16, 2001
Revised 45 CFR 46 Subpart B published as Final Rule. On November 13, 2001, the Department of Health and Human Services published in the Federal Register (Click Here) a Final Rule, with an effective date of December 13, 2001 which amends Subpart B of 45 CFR 46. These regulations provide additional protections for pregnant women and human fetuses involved in research. The final rule continues the special protections for pregnant women and human fetuses that have existed since 1975 and makes limited changes in terminology referring to neonates, clarifies provisions for paternal consent when research is conducted involving fetuses, clarifies language that applies to research on newborns of uncertain viability, and corrects technical errors.
November 15, 2001
Health Improvement Institute (Institute) is pleased to announce a national new awards program - Award for Excellence in Human Research Protection. The federal Office of Human Research Protection (OHRP) is the award program's founding sponsor. Institutions and individuals are eligible to enter the annual awards competition. Awards will be given for demonstrated excellence in promoting the well-being of people who volunteer to participate in research. The Institute is planning to make the first awards in December 2002. The publicity announcement may be found at http://www.hhs.gov/ohrp/references/AEHRPPR.pdf [PDF Document] and the form used to participate at http://www.hhs.gov/ohrp/references/AEHRPJN.pdf [PDF Document].
