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Announcements for 2009

 

(November 6, 2009) - Draft OHRP Guidance Documents for Public Comment

On November 6, 2009, the Office for Human Research Protections (OHRP) announced in the Federal Register the availability of two draft guidance documents. The first is entitled "Guidance on IRB Continuing Review of Research,” and the second is entitled “Guidance on IRB Approval of Research with Conditions.” OHRP is inviting public comments on both draft documents. Background information, the Federal Register notices of availability, the draft guidance documents, and instructions for how to submit comments can be accessed on the OHRP website at http://www.hhs.gov/ohrp/newsroom/rfc/.

 

 

(October 15, 2009) - New OHRP Frequently Asked Questions and Answers on Exempt Research Determination

OHRP posted on its website a new set of Frequently Asked Questions and Answers (FAQs) on Exempt Research Determination. These FAQs provide guidance on OHRP's current thinking on exempt research determination and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word "must" in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. The Exempt Research Determination FAQs can be accessed at: http://answers.hhs.gov/ohrp/categories/1564

 

 

(September 24, 2009) - Upcoming OHRP Research Community Forum in Seattle, WA

Save-the-date for an upcoming OHRP Research Community Forum entitled, "Protecting Research Participants: Ethical Challenges Within a Regulatory Framework," sponsored by the Northwest Association for Biomedical Research at the Bar Harbor Conference Center in Seattle, Washington on February 4, 2010. 

 

 

(September 17, 2009) -REMINDER: IMPORTANT NOTICE REGARDING REGISTRATION OF IRBs REVIEWING FDA-REGULATED RESEARCH - COMPLIANCE DATE OF SEPTEMBER 14, 2009

The following notice is being sent out on behalf of the Food and Drug Administration (FDA):

We believe there may be some confusion in the IRB community regarding IRBs currently reviewing FDA-regulated research who were registered in the OHRP database before July 14, 2009.  If those IRBs had voluntarily provided information concerning FDA-regulated studies, it will be visible when their information is accessed in the modified database, but that does not mean the IRB is registered with FDA.  All previous IRB records were migrated as "OHRP only" into the new registration database, which was activated on July 14, 2009.  This designation must be updated to read "OHRP/FDA" (or "FDA only," if that is the case) to register the IRB with FDA.  In addition, any existing FDA-specific information should be reviewed to determine if an update is necessary.  (FDA-specific information includes an estimate of the number of active FDA-regulated studies and a checklist for choosing the type of FDA-regulated research - drugs, biologics, devices, etc.)

To determine if a recent update accomplished the required change, you can search for your IRB information at http://ohrp.cit.nih.gov/search/.  An IRB search with your IRB # will display basic information including "type" near the far right.  If it does not read "OHRP/FDA" or "FDA only" you need to submit a new update (see below).

If you are updating your information to provide/update the FDA-specific information, use the electronic submission system page for updating registrations at http://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx.  After obtaining a submission number from the system, you will begin the update process.  To enter information for each separate IRB, access the pull-down list of IRB type and select "OHRP/FDA" or "FDA only."  If you had already registered, the information previously entered will appear when you "save and continue," along with data-entry fields to enable you to enter or update the FDA-specific information required by the new IRB registration rule.

For further information on FDA's IRB registration requirements contact Jean Toth-Allen, Ph.D., Office of Good Clinical Practice, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, HF-34, Room 16-85, Rockville, MD 20857, telephone (301) 827-1585, e-mail jean.toth-allen@fda.hhs.gov.

 

 

(July 17, 2009) - Availability of OHRP’s updated web-based electronic submission system for Federalwide Assurance (FWA) and Institutional Review Board (IRB) registration documents

OHRP’s updated web-based electronic submission system for submitting Federalwide Assurance (FWA) and Institutional Review Board (IRB) registration documents is now available at http://ohrp.cit.nih.gov/efile .

We understand that some users are experiencing technical difficulties when attempting to access and use the enhanced electronic submission system. 

We apologize for these technical difficulties and are working to resolve them. We encourage institutions and IRBs that do not immediately need to update an IRB registration or FWA to wait to submit any update while we focus our efforts on debugging the electronic submission system.   Please be aware that OHRP will take into account the various problems with the implementation of the enhanced electronic submission system, and will use available flexibility in its decision making if an entity is unable to comply with registration and FWA submission requirements due to these implementation issues. This flexibility will continue until the implementation issues with the electronic submission system are resolved.

If you have any questions about, or problems in attempting to use, the electronic submission system, please contact your regional/country coordinator listed at http://www.hhs.gov/ohrp/assurances/contact/index.html

 

 

(July 8, 2009) - Register Now !! OHRP Research Community Forum in New York, NY on September 11, 2009

REGISTER NOW for an upcoming OHRP Research Community Forum entitled, "On The Legal and Ethical Frontline," sponsored by The City University of New York, State University of New York at Stony Brook, Columbia University in the City of New York, and the Research Foundation of The City University of New York on September 11, 2009 in New York, New York. 

 

(July 8, 2009) - OHRP Electronic Submission System for FWAs will be Shut Down during the period of July 8 through July 13, 2009)

OHRP's current web-based system for electronic submission of Federalwide Assurance (FWA) documents (and Institutional Review Board (IRB) registration documents) will be shut down during the period of July 8 through July 13, 2009 to migrate the current FWA records to an updated electronic submission system.  During that period, new FWAs, or updates to, and renewals of, existing FWAs cannot be submitted, nor can they be processed by OHRP.  In addition, individuals will not be able to access the list of OHRP-approved FWAs on the OHRP website or view the list of FWA documents received by OHRP during the last 60 days. The updated web-based electronic submission system for FWAs and IRB registrations will be available on July 14, 2009.

 

 

(July 8, 2009) - Effective Date of New OHRP Institutional Review Board Registration Requirements Approaching

On July 14, 2009, the new Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations requiring registration of institutional review boards (IRBs) that were published in the Federal Register on January 15, 2009 (74 FR 2399 and 74 FR 2358) will go into effect.  The Office for Human Research Protections' (OHRP's) IRB registration system will be compatible with the requirements of both the HHS and FDA regulations

The HHS IRB registration requirements were added as a new subpart E to the HHS protection of human subjects regulations (45 CFR part 46).  Subpart E requires all IRBs that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use (i.e, a Federalwide Assurance (FWA)) by OHRP to register with HHS.  Required IRB registration information includes: contact information for the person providing the registration information; approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS; and, approximate number of full-time equivalent positions devoted to the IRB's administrative activities. 

For any IRB currently registered with OHRP, the institution or organization operating the IRB must submit all information required under HHS regulations at subpart E of 45 CFR part 46 by the current expiration date previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson.  Institutions or organizations operating IRBs currently registered with OHRP that review FDA-regulated research will need to update registration information to include FDA-specific information once the registration rule is effective.  For IRBs that only review FDA-regulated research, an initial registration is required.  [For questions regarding registration of IRBs that review FDA-regulated research, see FDA contact information below].

For any IRB not currently registered with OHRP, the IRB must be registered with OHRP before being designated on an FWA and reviewing research conducted or supported by HHS.

Note that beginning on July 14, 2009, institutions and organizations needing to register a new IRB, or update or renew an existing IRB registration, must do so electronically via the OHRP website at http://ohrp.cit.nih.gov/efile/ unless the institution or organization lacks the ability to register its IRBs electronically.  OHRP's current electronic IRB registration submission system is being updated so that it corresponds to the requirements of both IRB registration rules.  The updated registration system will "go live" on July 14, 2009.  In addition, the Office of Management and Budget (OMB) recently approved the information collection requirements in both rules.  Thus, beginning on July 14, 2009, IRB registration information for both rules will be collected on the OMB-approved modified IRB registration form (OMB No. 0990-0279), which will be posted on the OHRP website.

In order to implement the changes required to update the system for registering an IRB electronically via the OHRP website, the system will be shut down during the period of July 8 through July 13.  During that period, new IRB registrations, or updates to, and renewals of, existing IRB registrations cannot be submitted, nor can they be processed by OHRP.  In addition, individuals will not be able to access the list of OHRP registered IRBs on the OHRP website; or view IRB registration documents received by OHRP during the last 60 days.

The final IRB registration rule that was published in January as the new subpart E addition to 45 CFR part 46 can be accessed at: http://edocket.access.gpo.gov/2009/E9-588.htm. The FDA IRB registration final rule (new 21 CFR 56.106) can be accessed at http://edocket.access.gpo.gov/2009/E9-682.htm.

For further information on OHRP's IRB registration requirements contact Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, telephone (240) 453-6900, email Irene.Stith-Coleman@hhs.gov

For further information on FDA's IRB registration requirements contact Jean Toth-Allen, Ph.D., Good Clinical Practice Program, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, HF-34, Room 16-85, Rockville, MD 20857, telephone (301) 827-1585, email jean.toth-allen@fda.hhs.gov

 

 

(April 7, 2009) - Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards

OHRP has posted on its website a finalized guidance document entitled, “Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.” The guidance document provides OHRP’s first formal guidance on this topic. The document, which is available on the OHRP website at http://www.hhs.gov/ohrp/policy/gina.html and http://www.hhs.gov/ohrp/ohrp/policy/gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRBs) that review, non-exempt human subjects research involving genetic testing or collection of genetic information. The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services regulations for the protection of human subjects (45 CFR part 46). The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2009/E9-7782.htm or http://edocket.access.gpo.gov/2009/pdf/E9-7782.pdf.

OHRP welcomes comments on this new guidance document. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with citation of the specific document related to the comments in the subject line.

 

 

(March 5, 2009) - Request for information and comments on IRB accountability

The Office for Human Research Protections (OHRP), has issued a Federal Register notice requesting information and comments from the public about whether the office should pursue a notice of proposed rulemaking to enable OHRP to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of 45 CFR part 46.

More complete information regarding the request for comments is available at http://www.hhs.gov/ohrp/newsroom/rfc/.

 

 

(February 18, 2009) - Register Now for the OHRP Research Community Forum in Ann Arbor, MI on May 14, 2009 

Register NOW for the OHRP Research Community Forum “Reducing Regulatory Burden: Real Strategies for Real Change” in Ann Arbor, MI on May 14, 2009. This forum is being co-sponsored by the University of Michigan – Ann Arbor. 

 

 

(February 13, 2009) - OHRP Posts Revised Compilation of Recent Determinations of Noncompliance

OHRP has revised its 2005 document "Significant Findings and Concerns of Noncompliance," to delete determinations that have not been made recently, add new determinations that have been made since 2005, and provide additional regulatory citations. The revised document, "OHRP Compliance Oversight Activities: Determinations of Noncompliance," can be found at http://www.hhs.gov/ohrp/compliance/findings/index.html.

 

 

(February 4, 2009) - Upcoming OHRP Research Community Forum in Ann Arbor, MI

Save-the-date for an upcoming OHRP Research Community Forum entitled, "Reducing Regulatory Burden: Real Strategies for Real Change," sponsored by University of Michigan in Ann Arbor, Michigan on May 14, 2009. 

 

 

(January 29, 2009) - OHRP Posts Correspondence on Engagement in Research 

OHRP has posted a new item of correspondence on “Determining When Institutions Are Engaged in Research” dated January 13, 2009. This OHRP correspondence comments on several issues raised in an on-line discussion of the “IRB Forum,” to which a number of people post messages related to implementation of human subjects protections. OHRP's response can be viewed at http://www.hhs.gov/ohrp/policy/correspondence/. Among the topics addressed in the correspondence are the differences between an interaction and an intervention, and how to determine when the employees of a contractor should be considered agents of the FWA-holding institution that hired the contractor.

 

 

(January 15, 2009) - New Institutional Review Board Registration Requirements

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), has added a new subpart E to the HHS protection of human subjects regulations (45 CFR part 46). This new subpart requires institutional review boards (IRBs) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS. The registration information includes contact information, approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. The 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 this final rule, the IRB registration system will be compatible with the IRB registration requirements of the Food and Drug Administration (FDA), which are simultaneously published as a final rule in this issue of the Federal Register, allowing the operation of a single HHS IRB registration system.

Note that the rule is effective July 14, 2009. This delayed effective date is necessary to (a) allow refinement of the electronic registration system so that it corresponds to this final rule and the FDA's final rule, and (b) obtain Office of Management and Budget review and approval for the information collection requirements of this rule.

Initial registration with all required information must be submitted within 60 days of the effective date of the rule, by September 14, 2009. For any IRB registered with OHRP as of September 14, 2009, the institution or organization operating the IRB must submit all information required under this rule by the three-year expiration date previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson.

Note that prior to the effective date of the new rule, the requirements and process for registering an IRB with OHRP will remain unchanged. Organizations and institutions with IRBs that are currently registered with OHRP do not need to take any action at the present time. OHRP will provide additional instructions and guidance prior to the effective date of the new rule.

Also, note that once the rule becomes effective, institutions and organizations needing to register an IRB, or update or renew an existing IRB registration, will be required to do so electronically via the OHRP website, unless the institution or organization lacks the ability to register its IRBs electronically.

The final rule can be accessed at: http://edocket.access.gpo.gov/2009/E9-588.htm. The FDA's IRB registration final rule can be accessed at http://edocket.access.gpo.gov/2009/E9-682.htm.

 

 

(January 5, 2009) - OHRP Asks for Comments on its Website

OHRP plans to revise its website (www.hhs.gov/ohrp). We want to make the site easier to use and more useful to you. We welcome any feedback or suggestions on content, format, navigation or any other aspect of the site from web visitors.

Please send your comments to
OHRPWeb@hhs.gov


Content created by Assistant Secretary for Health - Off. for Human Research Protections