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Human Subjects Division (HSD)

Regulatory Updates

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  • OHRP Announces the Availability of Draft Guidance on Disclosing Reasonably Foreseeable Risks in Evaluating Standards of Care

    Oct 24, 2014 at 12:00am

    On October 24, 2014, the Office for Human Research Protections (OHRP), in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), announced in the Federal Register the availability of a draft guidance document entitled, “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care,” and are inviting public comments on that document. The draft guidance pertains to nonexempt research involving human subjects designed to evaluate treatments or procedures that are medically recognized standards of care. The guidance applies to such research that is conducted or supported by HHS.

    The draft guidance explains how to apply the HHS Regulations at 45 CFR Part 46 to studies that are designed to evaluate one or more standards of care. It discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with standards of care. It also discusses disclosing certain reasonably foreseeable risks to prospective subjects when seeking their informed consent to participate in such research activities. It explains OHRP’s position that in general the reasonably foreseeable risks of research in a study include the already identified risks of the standards of care being evaluated as a purpose of the research when the risks being evaluated are different from the risks some of the subjects would be exposed to outside of the study. Reasonably foreseeable risks must be described to prospective subjects when seeking their informed consent in accordance with 45 CFR 46.116(a)(2).

    The draft guidance addresses the following topics:

    1. What are “standards of care”?
    2. What are “risks of research” in studies evaluating risks associated with standards of care?
    3. When is evaluating a risk in a research study considered to be a “purpose” of the research study?
    4. Are the risks of research associated with the purposes of studies of standards of care “reasonably foreseeable risks" that must be disclosed to prospective subjects in the informed consent process?

    The draft guidance, when finalized, will provide OHRP’s first formal guidance on this topic.

    The Federal Register notice of availability, the draft guidance document, and instructions for how to submit comments can be accessed on the OHRP website at: http://www.hhs.gov/ohrp/newsroom/rfc/.

  • OHRP Posts Correspondence Related to the Application of 45 CFR part 46 to a National Health Registry

    Oct 16, 2014 at 12:00am

    OHRP has posted its correspondence with the director of a national health registry in letters dated August 11, 2011 and December 29, 2011 responding to questions about the application of 45 CFR Part 46 to the activities related to the registry, in the belief that others may find the content to be useful. The letters clarify the following points:

    • If research conducted by a registry is not part of or supported by HHS, or covered by an HHS federalwide assurance, then the regulatory requirements of 45 CFR 46 do not apply to that research activity even if it would be considered nonexempt human subjects research under those regulations.
    • The application of the regulations to an activity depend in part on whether the activity meets the regulatory definition of “research,” which depends on the specific facts of the activity, and not whether it is labeled “quality improvement” or something else.
    • A research registry could be designed so that the regulations would not apply to the creation and operations of the registry through various mechanisms, including the use of codes instead of identifiers in the original release of data to a registry, or the use of computer programming to merge identifiable data-sets without any person being able to view the data in identifiable form.
    • Institutions holding information originally obtained for clinical or administrative purposes whose agents simply release identifiable private information to a registry are not engaged in any research conducted by the registry, and do not have to meet any regulatory requirements of the 45 CFR 46 in this regard
    • Outside researchers who request the release of non-identifiable private information from the registry for secondary research analyses are not conducting “human subjects” research, and therefore the regulations do not apply to this activity, and there is no requirement for either IRB review or informed consent.
    • If healthcare providers enhance or extend their standard of care in follow-up interviews with their patients and those changes would have been implemented regardless of any secondary research purpose, then the data collected through those interviews would not be considered research; in contrast, if part of the reason for the change in interview data collected is for research, then the data collection would be considered part of a research activity.
    • Where appropriate, OHRP supports the use of single or central IRB review and approval of research conducted by clinical registries in circumstances where more than one institution is engaged in the research.

    OHRP notes that the activities of such registries may also need to meet requirements under the Health Insurance Portability and Accountability Act (HIPAA), administered by the Office for Civil Rights (OCR). OHRP encourages institutions with questions about the HIPAA regulations to contact OCR directly, at (800) 368-1019.

    OHRP is working to provide helpful information to institutions and the public regarding the applicability of the regulations to the various kinds of activities carried out by health registries and the institutions involved in some way in those activities. OHRP has asked the Secretary’s Advisory Committee on Human Research Protections (SACHRP) to provide recommendations related to this topic, and continues to develop information that can be used to protect human subjects in research and avoid unnecessary confusion and administrative burden.

    The full text of OHRP’s August 11, 2011 and December 29, 2011 correspondences can be accessed at: http://www.hhs.gov/ohrp/policy/Correspondence/correspondence_regarding_the_application_of_45_cfr_part_46_to_the_activities_related_to_a_national_health_registry.html

  • FDA Announces Final Guidance on FDA Decisions for Investigational Device Exemption (IDE) Clinical Investgations

    Aug 19, 2014 at 12:00am

    The Food and Drug Administration (FDA) has recently issued a final guidance document, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.” The FDA is committed to improving US patient access to new devices by strengthening and streamlining the clinical trial enterprise so that clinical trials are conducted in the US in an efficient, cost-effective manner while maintaining appropriate patient protections. 

    The final guidance describes the FDA’s decision-making and communications regarding applications from companies that want to conduct medical device clinical trials in the US. It also describes more flexible options for clinical study approvals that allow clinical studies to begin sooner while ensuring patient protections.

     The final guidance outlines:

     

    • Processes to allow more efficient study enrollment
    •  Provides information regarding the FDA’s decision-making processes to improve predictability of the regulatory process
    • Introduces communication intended to improve the transparency of FDA’s decision-making process
  • OHRP: 2014 Edition of International Compilation of Human Research Standards Now Available

    Dec 3, 2013 at 5:44am

    The 2014 edition of the International Compilation of Human Research Standards has been released and is now available on-line: http://www.hhs.gov/ohrp/international/index.html.

    The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 107 countries, as well as standards issued by a number of international and regional organizations. The standards address such issues as informed consent, research ethics committee review, reporting requirements, vulnerable populations, and more.

    Three new countries are spotlighted in the 2014 edition: Cameroon, Mozambique, and Zambia. The 2014 edition also includes hundreds of updates from the 2013 edition.

    The listings are organized into seven categories:

    1. General Research
    2. Drugs and Devices
    3. Research Injury
    4. Privacy/Data Protection
    5. Human Biological Materials
    6. Genetic
    7. Embryos, Stem Cells, and Cloning

    Many of the listings include a hyperlink, allowing the user to link directly to the law, regulation, or guideline of interest. The Compilation is available in both PDF and MS Word versions.

    Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.

  • FDA Proposes New Rule on Acceptance of Data from Clinical Studies for Medical Devices

    Feb 26, 2013 at 8:01am

    The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices.  The FDA is proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects.  The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies.  As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for RDA acceptance of data from clinical studies conducted inside the United States.  The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.

    The proposed rule is available using the following web link: http://www.gpo.gov/gdsys/pkg/FR-2013-02-25/pdf/2013-04201.pdf

    Comments are due by May 28, 2013.

  • OHRP: 2013 Update to the International Compilation of Human Research Standards-Now Available

    Nov 27, 2012 at 1:45pm

    The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations.  The Compilation is designed for use by IRBs, researchers, sponsors, and others.  Many of the listings embed hyperlinks to the source document.

    The 2013 edition is now available, and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html. One new country is featured in the 2013 Edition: Ecuador.

    As in the past, the new edition updates the human research standards based on information provided by in-country experts.

  • OHRP Archives Guidance Document on IRB Knowledge of Local Research Context

    Aug 3, 2012 at 5:27am

    OHRP has moved the guidance entitled "IRB Knowledge of Local Research Context" to its archive of guidance documents no longer in effect.  That guidance was last updated in 2000, and, due to developments over the interveneing years, much of the information in the guidance is now outdated or inaccurate.  OHRP plans to develop new guidance that will address the issues discussed in the now-archived July 21, 2000 guidance.

    If you have specific questions regarding the issues discussed in the archived guidance, please contact OHRP by phone at (866) 447-4777 (toll-free within the U.S.) or (240) 453-6900, or by e-mail at ohrp@hhs.gov.

    All archived OHRP documents may be accessed on the OHRP Web site at: http://www.hhs.gov/ohrp/archive

  • FDA Issues May 2012 Update to the HSP/BIMO Initiative Accomplishments Report

    May 29, 2012 at 3:53am

    A May 2012 updated to the Human Subjects Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative Accomplishments Report has been issued and is available on the FDA's website at the following link:

    http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htm

    The report highlights FDA's significant accomplishments and initiatives relating to the conduct of clinical trials from September 2010 through the present.

  • FDA Issues Final Guidance on IRB Continuing Review

    Mar 3, 2012 at 12:00am

    FDA has issued the final guidance, "IRB Continuing Review after Clinical Investigation Approval." This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations.  This guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.

    To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research.  This guidance document was developed as a part of these efforts.

    The document is now available using the following web link: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf

  • FDA Issues Guidance on New Informed Consent Requirements

    Feb 9, 2012 at 4:29am

    FDA has issued the guidance, "Questions and Answers on Informed Consent Elements, 21 CFR 50.25(c)." This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand the new informed consent requirement set forth in 21 CFR 50.25(c). The guidance will assist those involved in applicable FDA-regulated clinical trials better understand the new informed consent requirement, including small businesses.

    The document is now available using the following web link: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

  • OHRP Correspondence on "Non-engaged" Scenarios

    Sep 22, 2011 at 7:36pm

    OHRP has posted a new item of correspondence on its website regarding "non-engaged" scenarios. OHRP's statement is included below, and can also be viewed at http://www.hhs.gov/ohrp/policy/Correspondence/index.html.

    Correspondence on "Non-engaged" Scenarios As noted in OHRP's October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research, the scenarios of when an institution is not engaged in human subjects research are not all-inclusive (see http://www.hhs.gov/ohrp/policy/engage08.pdf).  Since the guidance document was issued, on a case-by-case basis in response to specific requests from institutions, OHRP has found some institutions in certain circumstances to be not engaged, even though the exact non-engaged scenario is not included in OHRP's October 16, 2008 guidance document.

    Since these exceptions have been granted on a case-by-case basis in certain circumstances, institutions should not extrapolate from these descriptions and determine they are not engaged.  If investigators or institutions have questions about whether their involvement in a non-exempt human subjects research study would make them engaged in the research, contact OHRP by phone at (866) 447-4777 (toll-free within the U.S.) or (240) 453-6900, or by e-mail at ohrp@hhs.gov.  When OHRP receives requests that institutions be considered "not engaged", the analysis will be guided by consideration of whether the institution's participation is so limited or marginal that considering them to be "engaged" would not meaningfully add to protection of the human subjects in research.  The following are descriptions of the activities that OHRP determined did not make the institution engaged in the specific non-exempt human subjects research projects that were in question:

    Awardee Institution

    The institution received a grant award from the National Institutes of Health (NIH) for the conduct of non-exempt human subjects research (i.e. was an awardee institution), but no specific human subjects research studies were described in the grant application.  In this case, the awardee institution planned to solicit research proposals that would be funded under the awardee institution's NIH grant.  Institutions other than the awardee institution could receive these sub-awards from the awardee institution.  The institution receiving the NIH award would have no involvement in the conduct of the research conducted at the other institutions.

    Note that in this case, OHRP determined that the awardee institution of the NIH award was not engaged in the non-exempt human subjects research studies that were to be carried out by other institutions under the award.  This was an exception to the "engaged" scenario described in section III.A.(1) of OHRP's October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research.

    Data Center

    The institution's employees helped to maintain and operate a data center that had been approved by an institutional review board (IRB), and these employees also obtained individually identifiable private information from the data center to assist investigators from engaged institutions with any of the following activities, provided the activities had been described in the IRB-approved data center protocol:

    1. Consulting with an investigator from an engaged institution on elements within the dataset that would meet the investigator's needs;
    2. Consulting with an investigator from an engaged institution on analytic strategy;
    3. Designing the analysis for an investigator from an engaged institution;
    4. Developing analytic code for an investigator from an engaged institution; and
    5. Interpreting the results of analyses run in the data center for an investigator from an engaged institution.

    Note that OHRP determined that the institution operating the data center was not engaged in the human subject research being carried out by other institutions, even though the services provided by the institution operating the data center were not typically performed by the institution for non-research purposes.  This is in contrast to the "non-engaged" scenario described in section III.B.(1) of OHRP's October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research. The “non-engaged” scenario described in section III.B.(1) of OHRP’s guidance document is limited to commercial or other services that are typically performed by an institution for non-research purposes, and identifies other conditions that need to be satisfied.

    Magnetic Resonance Imaging (MRI) Research Facility

    The MRI research facility’s involvement in human subjects research was limited to the following:

    1. Permitted use of their MRI research facility for intervention or interaction with subjects by investigators from another institution that was engaged in the research; and
    2. Involved their employees or agents interacting or intervening with human subjects in the research by providing investigators from the engaged institution with only technical assistance in operating the MRI equipment.

    Note that OHRP determined that the MRI research facility was not engaged in the human subjects research being carried out by other institutions even though the MRI services being provided were not typically performed by the MRI research facility for non-research purposes. This is in contrast to the “non-engaged” scenario described in section III.B.(1) of OHRP’s October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research. The “non-engaged” scenario described in section III.B.(1) of OHRP’s guidance document is limited to commercial or other services that are typically performed by an institution for non-research purposes, and identifies other conditions that need to be satisfied.

    (This correspondence is available in PDF format at http://www.hhs.gov/ohrp/policy/Correspondence/nonengagemementexamples2011.pdf.pdf [PDF 28KB].)

  • OHRP and FDA Announce the Availability of a Joint Draft Guidance Document on Exculpatory Language for Public Comment and Review

    Sep 7, 2011 at 9:54am

    On September 7, 2011, the Office for Human Research Protections (OHRP) and the Food and Drug Administration announced in the Federal Register the availability of a joint draft guidance document entitled, "Guidance on Exculpatory Language in Informed Consent," and are inviting public comments on that document.  The joint draft document, among other things, does the following:

    1. Provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent.
    2. Includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory.
    3. Clarifies that OHRP and FDA have concluded that language in informed consent is not exculpatory if it informs subjects that, by agreeing to allow the use of their biospecimens for research purposes, they are giving up any legal right to be compensated for the use of the biospecimens.  This represents a change from OHRP's November 15, 1996 guidance on point, "'Exculpatory Lanague' In Informed Consent," which identified as "exculpatory" certain informed consent statements in which subjects gave up any rights they might have in their biospecimens.

    OHRP and FDA now consider these statements to be acceptable for inclusion in informed consent, and they are restated as examples of acceptable language in the draft guidance.  Thus, for example, it would now be acceptable to include language in a consent form such as 'I give up any property rights I may have' in biospecimens, or 'I voluntarily and freely donate' the biospecimens to a particular institution.

    When finalized, the draft document will supersede OHRP's November 15, 1996, guidance entitled, "'Exculpatory Language' in Informed Consent" and question number 52 in FDA's January 1998 guidance entitled, "Institutional Review Boards Frequently Asked Questions - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators."

    The Federal Register notice of availability, the joint draft guidance document, and instructions for how to submit comments can be accessed on the OHRP website at http://www.hhs.gov/ohrp/newsroom/rfc/. The joint draft guidance document can also be accessed on the FDA website at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm

  • OHRP: HHS Announcement to extend the comment period on Proposal to Improve Rules Protecting Human Research Subjects Will be Published in Tomorrow's Federal Register

    Aug 31, 2011 at 6:45am
    The Department of Health and Human Services (HHS) will announce in tomorrow's issue of the Federal Register that it is extending the comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects might be modernized and revised to be more effective.  That ANPRM entitled, "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," was published in the Federal Register on July 26, 2011 (Volume 76, Number 143, page 44512), with a deadline for comments of September 26, 2011. Since the ANPRM was published, HHS has received requests to extend the comment period to allow sufficient time for a full review of the ANPRM and welcomes comments.  The comment period will be extended by 30 days and thus will end on October 26, 2011.  To view a copy of the notice currently available for public inspection and that will be published in the September 1, 2011 Federal Register, visit http://www.ofr.gov/OFRUpload?OFRData/2011-22341_PI.pdf.
  • FDA Issues Draft Guidance on Risk-Based Approaches for Monitoring Clinical Investigations

    Aug 30, 2011 at 6:57am

    FDA has issued draft guidance on "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring." The guidance document is now available from the FDA's web site using the following web link:

     http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdfguidance

    The new draft guidance is being issued to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof.  This guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities during clinical investiations. This guidance describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to effectively oversee a study.

    Comments to this draft guidance are due by November 28, 2011.

  • OHRP: HHS Proposal to Improve Rules Protecting Human Research Subjects Published in Today's Federal Register

    Jul 26, 2011 at 10:59am

    The U.S. Department of Health and Human Services announcement that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects was published as an Advance Notice of Proposed Rulemaking (ANPRM) in the July 26, 2011 issue of the Federal Register.  In that ANPRM, entitled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," the government seeks the public's input on an array of issues related to the ethics, safety, and oversight of human research, before making changes to the regulations.  Those regulations, often referred to as the Common Rule, have been in place since 1991.  The proposed changes in the ANPRM are designed to strengthen protections for human research subjects.  The ANPRM can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm

     

    To be assured consideration, comments must be received no later than 5 p.m. on September 26, 2011.  For additional information about the ANPRM, including how to submit or browse comments, visit http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.

     

  • OHRP: Guidance on Reporting Incidents to OHRP

    Jul 5, 2011 at 11:40am
    OHRP has posted on its website a finalized guidance document entitled, "Guidance on Reporting Incidents to OHRP." This guidance replaces OHRP's May 27, 2005 guidance entitled "Guidance On Reporting Incidents To OHRP" (http://www.hhs.gov/ohrp/compliance/reports/index.html). This guidance has been updated to clarify what information regarding serious or continuing noncompliance by the institutional review board needs to be reported, and to update OHRP's contact information.  We are also pleased to announce a new email box for sending incident reports.  The address is IRPT.OS@hhs.gov. We encourage institutions to submit incident reports to this email address, PDF or Word format preferred.
  • OHRP: Updated Written IRB Procedures Guidance

    Jul 5, 2011 at 11:35am

    OHRP has updated its Guidance on Written IRB Procedures. The July 1, 2011 guidance document replaces OHRP's January 15, 2007 guidance on this topic. Specifically, the updated document has been changed as follows; updated sections are identified in the parenthetical following each description of the changes:

    1. Guidance related to continuing review has been replaced with content from OHRP's November 10, 2010 document, "Guidance on Continuing Review of Research," and a cross-reference to the continuing review guidance document has been added (see Section A.(2)(b) and Section B.(2)(b)).
    2. A cross-reference to OHRP's January 15, 2007 document, "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events," has been added (see Section A.(3)).
    3. Guidance related to the approval of research with conditions has been replaced with content from OHRP's November 10, 2010 document, "Guidance on IRB Approval of Research with Conditions," and a cross-reference to the guidance document on approval of research with conditions has been added (see Section A.(5)).
    4. All URLs referenced in the document have been updated to link to OHRP's new website.
    5. A closing paragraph was added to the end of the document to provide OHRP's contact information.
  • OHRP: Notice - Changes to the Federalwide Assurance (FWA) and Terms of Assurance

    Jun 20, 2011 at 12:00am

    OHRP announced the availability of the revised FWA form and Terms of Assurance which have been approved by the Office of Management and Budget.  The key changes in the revised form and terms are the following:

    • Institutions now must designate all internal IRBs on their FWA. If an institution has no internal IRBs, only one external IRB needs to be designated;
    • Institution's Signatory Officials can now sign their FWA submissions electronically on-line. The requirement to submit a hard copy signature page has been eliminated;
    • Institutions now must submit their FWAs (new submissions, updates and renewals) on-line, unless they are unable to do so;
    • The standard approval period for an FWA is now 5 years, instead of 3 years;
    • Now there is a single version of the FWA form and the Terms of Assurance for domestic and international institutions.

    Announcement: http://www.hhs.gov/ohrp/index.html

    Electronic system: http://ohrp.cit.nih.gov/efile/

    Forms: http://www.hhs.gov/ohrp/assurances/forms/index.html

  • FDA: Guidance - Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies

    Jun 20, 2011 at 12:00am
    This document provides guidance to sponsors and investigators on enforcement of FDA's final rule, "Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans" (75 FR 59935, September 29, 2010). This guidance contains information regarding the Agency's intent to exercise enforcement discretion regarding the reporting requirements in the final rule until September 28, 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM257976.pdf
  • FDA: Good Clinical Practice/Human Subject Protection Update

    May 24, 2011 at 7:58am

    FDA has issued new draft guidance, "Financial Disclosure by Clinical Investigators, Guidance for Clinical Investigators, Industry and FDA Staff."  The document is now available from FDA's web site at the following link:

    http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf

    This guidance is intended to assist clinical investigators, industry and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators, 21 CFR part 54.

    Comments to the draft guidance are due by July 25, 2011.

  • FDA Proposes New Rule on Disqualification of a Clinical Investigator

    Apr 13, 2011 at 9:33am
    Good Clinical Practice/Human Subject Protection Update

    The Food and Drug Administration is proposing to amend its regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

    The proposed rule is now available using the following web link: http://www.gpo.gov/fdsys/pkg/FR-2011-04-13/pdf/2011-8786.pdf

    Comments to this proposed rule are due by July 12, 2011.

  • FDA: Final Guidance - Exception from Informed Consent Requirements for Emergency Research

    Apr 5, 2011 at 12:00am

    FDA has issued the final guidance, “Exception from Informed Consent Requirements for Emergency Research.”  The document is now available using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf.

  • FDA: Final Guidance for Clinical Investigators, Sponsors and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection

    Feb 2, 2011 at 9:31am

    The link to the guidance document Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection has been updated from the draft guidance document to the final guidance document.

    This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems including certain adverse events reports, to the institutional review board (IRB) under Title 21 of the Code of Federal Regulations (21 CFR) part 56 (Institutional Review Boards), part 312 (Investigational New Drug Application), and part 812 (Investigational Device Exemptions). Specifically, the guidance provides recommendations for sponsors and investigators conducting investigational new drug (IND) trials to help them differentiate between those adverse events that are unanticipated problems that must be reported to an IRB and those that are not. The guidance also makes suggestions about how to make communicating adverse events information to IRBs more efficient.

    See: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf

  • FDA: Draft Guidance for Industry: Electronic Source Documentation in Clinical Investigations

    Jan 13, 2011 at 12:13am
    This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations.  This guidance is intended to ensure the reliability, quality, integrity, and tracability of electronic source data and source records maintained at the site for FDA inspection. See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052.pdf
  • FDA: Informed Consent Elements - Final Rule

    Jan 10, 2011 at 1:14pm

    The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank.  The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this databank also is required by statute.  This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

    DATES:

    Effective date: This rule is effective March 7, 2011.

    Compliance date: The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date.

    See the Federal Register here: http://edocket.access.gpo.gov/2011/pdf/2010-33193.pdf

  • ORI: To Release Interactive Video on Research Integrity

    Jan 6, 2011 at 12:00am

    A video simulation on research integrity, entitled "The Lab" will be released soon on the ORI web site and as a DVD. In the simulation, research misconduct causes a noted lab to lose funding, creates bad publicity to the university, and eventually causes the withdrawal of a multi-million dollar endowment.  In "The Lab," viewers have the opportunity to undo the damage by assuming the roles of a graduate student, post doc, principal investigator, and a research integrity officer and make decisions to prevent misconduct from occurring unnoticed.  The interactive video addresses the handling of misconduct, data management, authorship, mentoring, work-life balance, and other issues that today's researchers face.

    The trailer can be viewed at http://ori.hhs.gov/TheLab

  • OHRP: 2011 Edition of the International Compliation of Human Subject Protections Now Available

    Dec 20, 2010 at 8:35am

    The 2011 edition of the International Compilation of Human Subject Protections has just been released and is now available on-line. The document can be seen at: http://www.hhs.gov/ohrp/international/intlcompilation/hspcompilation-v20101130.pdf

    The updated Compilation includes a listing of over 1,000 laws, regulations, and guidelines on human subject protections in 101 countries and from several international organizations. The new Compilation also features the standards regarding device research, which were identified in 44 countries. These laws, regulations, and guidelines are classified into six categories:

    • General
    • Drugs and Devices
    • Privacy/Data Protection
    • Human Biological Materials
    • Genetic issues
    • Embryos, Stem Cells, and Cloning

    New countries included in this year's edition are Belarus, Grenada, Pakistan, Rwanda, and Tunisia. Many of the listings include a hyperlink, allowing the reader to link directly to the law, regulation, or guideline of interest.

    Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world.

  • OHRP: Guidance on IRB Approval of Research with Conditions

    Dec 2, 2010 at 6:28pm

    OHRP has posted on its website a finalized guidance document entitled, "Guidance on IRB Approval of Research with Conditions." The guidance document provides OHRP's first formal guidance on this topic.  The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback.

    The finalized guidance document is available on the OHRP website at: http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or  http://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf.

    The Federal Register notice announcing the availability of this new guidance document can be found at: http://edocket.access.gpo.gov/2010/2010-30201.htm or http://edocket.access.gpo.gov/2010/pdf/2010-30201.pdf.


     
  • OHRP: Guidance on IRB Continuing Review of Research

    Dec 2, 2010 at 6:27pm

    OHRP has posted on its website a finalized guidance document entitled, "Guidance on IRB Continuing Review of Research." The guidance document supersedes OHRP's January 15, 2007 guidance entitled "Guidance on Continuing Review." The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback.

    The finalized guidance document is available on the OHRP website at: http://www.hhs.gov/ohrp/policy/continuingreview2010.html or http://www.hhs.gov/ohrp/policy/continuingreview2010.pdf.

    The Federal Register notice announcing the availability of this new guidance document can be found at: http://edocket.access.gpo.gov/2010/2010-30198.htm or http://edocket.access.gpo.gov/2010/pdf/2010-30198.pdf.

  • FDA: Draft Guidance: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND

    Oct 21, 2010 at 8:28am

    This guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an investigational new 25 drug application (IND), as described in Title 21 of the Code of Federal Regulations, part 312 (21 26 CFR part 312) (the IND regulations). This guidance describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations.

    (See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf )

  • OHRP: Revised FAQ Regarding Engagement in Research

    Oct 14, 2010 at 10:34am

    In the FWA frequently asked questions (FAQs), at http://answers.hhs.gov/ohrp/categories/1563, OHRP has revised the answer to Question #4: When is an institution considered to be "engaged in research"? The revisions include:

    • Adding "obtaining informed consent" as an activity that can make an institution engaged;
    • Removing the statement that pertained to awardee institutions bearing the ultimate responsibility for protecting human subjects, even when all human subjects activities are carried out by other institutions; and
    • Correcting the link at the end of the FAQ to link to the current guidance document.

    This FAQ was revised to be consistent with OHRP's October 16, 2008 guidance document on the Engagement of Institutions in Human Subjects Research. Specifically, consistent with OHRP's 2008 engagement guidance document, the FAQ was modified to clarify that an institution is generally considered to be engaged in human subjects research when its employees or agents obtain the informed consent of human subjects. OHRP also removed the statement in the FAQ that pertained to awardee institutions bearing the ultimate responsibility for protecting subjects involved in the research conducted under the award, even when all human subjects activities are carried out by other institutions. OHRP removed this statement to be consistent with OHRP's 2008 engagement guidance, which reflects OHRP's broader goal of directing communication about noncompliance to the institution or IRB most directly involved in any regulatory noncompliance with 45 CFR part 46 as appropriate. For an example of the application of this concept, see OHRP's recent determination letter at: http://www.hhs.gov/ohrp/detrm_letrs/YR10/sep10b.pdf.

  • FDA: Presentation - IRB: Compassionate and Emergency Use

    Oct 14, 2010 at 8:30am

    The FDA has released a presentation on Compassionate and Emergency Use. Learning objectives of this presentation include:

    • Understand when an emergency need to use an unapproved device may occur
    • Describe the role and responsibilities of the physician who wants to use the device on a patient for emergency or compassionate use
    • Identify the IRB's responsibilities in the compassionate use of an unapproved device
    Links to a variety of presentation formats:
  • OHRP: Clarification of "Noninvasive" in Expedited Review Category 3

    Oct 4, 2010 at 7:45am

    OHRP has posted a new item of correspondence on its view about the meaning of "noninvasive" as the term is used in expedited review category 3, which is the expedited review category that applies to the prospective collection of biological specimens for research purposes by noninvasive means. OHRP's statement can be viewed at:

    http://www.hhs.gov/ohrp/policy/protocol/index.html

    Specifically, that statement clarifies that OHRP agrees with the Food and Drug Administration's position that for purposes of expedited review category 3, the following procedures are considered noninvasive:

    Vaginal swabs that do not go beyond the cervical os; Rectal swabs that do not go beyond the rectum; and Nasal swabs that do not go beyond the nares.

  • FDA: Draft Guidance: Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies

    Sep 29, 2010 at 7:32am

    This document provides guidance to sponsors and investigators on safety reporting requirements for human drug and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. This guidance contains definitions used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have generated questions from sponsors and investigators.

    FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

    See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf

  • FDA: Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

    Sep 28, 2010 at 9:25am

    The Food and Drug Administration is issuing final regulations addressing the safety reporting requirements for investigational new drug applications (INDs) found in 21 CFR part 312 and for bioavailability and bioequivalence studies found in 21 CFR part 320.

    This final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials. The final rule lays out clear, internationally harmonized definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information.

  • OHRP: Guidance on Withdrawal of Subjects from Research

    Sep 21, 2010 at 6:13am

    OHRP has posted on its website a finalized guidance document entitled, "Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues." The guidance document provides OHRP's first formal guidance on this topic, and finalizes the draft guidance entitled, "Guidance on Important Consideration for when Participation of Human Subjects in Research is Discontinued."

    The link to the guidance is: http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html

  • FDA: Draft Guidance: Suicidality: Prospective Assessment of Occurrence in Clinical Trials

    Sep 15, 2010 at 6:10am

    The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. Specifically, this guidance addresses the Food and Drug Administration's (FDA's) current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development.

    The principles discussed in this guidance for the prospective assessment of suicidality involve actively querying patients about the occurrence of suicidal thinking and behavior, rather than relying on patients to report such occurrences spontaneously, followed by retrospective classification of events into appropriate categories. This guidance recommends a specific suicidality assessment instrument that can be used to conduct such prospective assessments and offers guidance on the use of alternative instruments.

    This guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community, and the public. This guidance does not address the complex analytic issues involved in the analysis of the suicidality data that will be derived from prospective assessments of suicidality; these issues will be addressed in separate guidances.

    See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225130.pdf

  • OHRP: Determinations Related to Allegations Regarding Dexamethasone Use in Pregnant Women

    Sep 3, 2010 at 6:44am

    The Office for Human Research Protections (OHRP) posted on its website OHRP's September 2, 2010 letter of determination along with a U.S. Food and Drug Administration (FDA) memorandum. OHRP received allegations concerning activities conducted by Dr. Maria New at Weill Cornell Medical College and Mount Sinai School of Medicine involving the use of dexamethasone in pregnant women at risk of carrying a female fetus with congenital adrenal hyperplasia.

    During OHRP's review, OHRP had numerous discussions with staff at FDA, and determined that the allegations raised by the complainants are unproven and did not find any evidence that Dr. Maria New violated the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46).

    See the letter here: http://www.hhs.gov/ohrp/detrm_letrs/YR10/sep10a.pdf

  • FDA: Comprehensive List of Guidance Documents

    Aug 9, 2010 at 7:21am

    The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past 5 years.

    See: http://www.federalregister.gov/articles/2010/08/09/2010-19342/comprehensive-list-of-guidance-documents-at-the-food-and-drug-administration

  • OHRP: Videos on YouTube

    Jul 14, 2010 at 5:54am

    OHRP is pleased to announce the availability for the first time of educational videos on the HHS YouTube channel. The videos are accessible through the OHRP playlist at: http://www.youtube.com/user/USGOVHHS#g/c/5965CB14C2506914 and include "Research Use of Human Biological Specimens and Other Private Information" and "Reviewing and Reporting Unanticipated Problems and Adverse Events," (both of which premiered and are still available also in RealPlayer format), in addition to two new videos "Institutional Review Board (IRB) Membership" and "General Informed Consent Requirements Parts I (Research Investigator)and II (Research Subject)."

  • OHRP: Correspondence Regarding Use of Central IRB in Multi-Site Research

    May 10, 2010 at 6:22am

    OHRP has posted on its website OHRP's April 30, 2010 response to a medical center regarding the use of a central IRB, as well as the incoming letter to OHRP. We have chosen to make these letters available since they address an issue that may be of interest to others (see: http://www.hhs.gov/ohrp/policy/protocol/cirb20100430.html).

    The OHRP letter clarifies that OHRP fully agrees with the Food and Drug Administration's position on the benefits of relying on a single central IRB for multi-center research. In addition, OHRP's letter clarifies that the advance notice of proposed rulemaking on IRB accountability that OHRP issued on March 5, 2009, was proposed to address this issue. Even in the absence of new regulation, the OHRP response also notes that OHRP is taking steps to address institutions' concerns about relying on an IRB external to the institution.

  • FDA: Guidance for IRBs, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions - Disqualification

    May 1, 2010 at 6:33am

    This Guidance document is intended to inform institutional review boards (IRBs), clinical investigators, and sponsors about the administrative action of disqualifying a clinical investigator from participating in studies involving investigational new drugs (including biologics) or devices. FDA may disqualify a clinical investigator from receiving investigational drugs (including biologics) and devices if FDA determines that the investigator has repeatedly or deliberately violated the agency's regulations, or has repeatedly or deliberately submitted false information to the sponsor or FDA in any required report.

    FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA's guidance documents means that something is suggested or recommended, but not required.

    See: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214008.pdf

  • OHRP: Revised Set of Frequently Asked Questions and Answers on IRB Registration

    Mar 29, 2010 at 6:21am

    OHRP posted on its website a revised set of Frequently Asked Questions and Answers (FAQs) on Institutional Review Board (IRB) Registration.

    These revised FAQs include guidance on the Department of Health and Human Services IRB requirements found in subpart E of 45 CFR 46 that were adopted on July 14, 2009. 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 revised OHRP IRB Registration FAQs can be accessed at: http://answers.hhs.gov/ohrp/categories/1565

  • FDA: Guidance Regarding IRB Continuing Review

    Jan 29, 2010 at 5:56am

    On January 13, the FDA announced in the Federal Register the availability of a draft guidance entitled, "Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval."

    See: http://edocket.access.gpo.gov/2010/2010-426.htm, or http://edocket.access.gpo.gov/2010/pdf/2010-426.pdf

    The draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.

    The document may be obtained at: http://www.regulations.gov, or at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm.

    Written or electronic comments on the draft guidance should be submitted by March 15, 2010.

  • OHRP: Student Pools and Use of Penalties

    Jan 11, 2010 at 6:28am

    OHRP has posted on its website a January 8, 2010 letter to a commercial company, which provides a web-based system for managing student subject pools, in the belief that others may find the content to be useful (see http://www.hhs.gov/ohrp/policy/protocol/ohrp20100108.html). This letter clarifies that imposing penalty credits on students who fail to show up for scheduled appointments with investigators without cancelling by a specified deadline violates the requirement of Department of Health and Human Services (HHS) regulations at 45 CFR part 46.116(a)(8). Such penalties may not be implemented for non-exempt human subjects research conducted or supported by HHS or for non-federally supported research to which an OHRP-approved Federalwide Assurance (FWA) applies. OHRP’s determination in this matter applies to any system used for managing student subject pools, not just the commercial web-based system referenced in OHRP’s letter.

  • OHRP: Two Guidance Documents on Multicenter Clinical Trials Archived

    Jan 5, 2010 at 6:34am

    OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are "Local IRB Review of Multicenter Clinical Trials" and "Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID)."

    These documents have been archived because OHRP's policy regarding local IRB review has changed and they no longer represent OHRP's policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.

    All archived OHRP documents may be accessed on the OHRP Web site at: http://www.hhs.gov/ohrp/archive/policy/archive.html.