Announcements for 2011
The OHRP will be co-sponsoring a National Research Community Forum with the National Institute of Environmental Health Sciences at the Raleigh Convention Center in Raleigh, North Carolina on March 21-22, 2012. This forum will provide a multifaceted agenda and showcase a sophisticated faculty. This is a wonderful education opportunity for professional colleagues who are involved in conducting research on human subjects. A copy of the Save-the-Date flyer is attached.
Save-the-Date for an upcoming OHRP Research Community Forum entitled, “Protecting Human Research Subjects: Best Practices in the Big Easy,” sponsored by Ochsner Medical Center at the Westin Canal Place in New Orleans, Louisiana on January 13, 2012.
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/correspond/.
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 email@example.com. 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:
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.
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:
- Consulting with an investigator from an engaged institution on elements within the dataset that would meet the investigator’s needs;
- Consulting with an investigator from an engaged institution on analytic strategy;
- Designing the analysis for an investigator from an engaged institution;
- Developing analytic code for an investigator from an engaged institution; and
- 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:
- 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
- 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 [PDF 28KB].)
(September 7, 2011) OHRP and FDA Announce the Availability of a Joint Draft Guidance Document on Exculpatory Language for Public Comment and Review
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:
- Provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent.
- Includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory.
- 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 Language’ 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/
The Department of Health and Human Services (HHS) is extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects might be modernized and revised to be more effective to October 26, 2011. 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. HHS is committed to affording the public a meaningful opportunity to comment on the ANPRM and welcomes comments. The Federal Register Notice announcing this extension can be accessed at http://www.gpo.gov/fdsys/pkg/FR-2011-09-01/html/2011-22341.htm.
To be assured consideration, comments must be received no later than October 26, 2011. For additional information about the ANPRM, including the ANPRM that was published on July 26, 2011 and how to submit or browse comments, visit http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.
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. HHS is committed to affording the public a meaningful opportunity to comment on 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 http://www.gpo.gov/fdsys/pkg/FR-2011-09-01/pdf/2011-22341.pdf.
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.
(July 5, 2011) Guidance On Reporting Incidents To OHRP
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.
(July 5, 2011) Updated OHRP Guidance on Written IRB Procedures
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:
- 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)).
- 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)).
- 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)).
- All URLs referenced in the document have been updated to link to OHRP’s new website.
- A closing paragraph was added to the end of the document to provide OHRP’s contact information.
June 27, 2011) OHRP announces new SACHRP members
OHRP is pleased to announce the selection of four new members of the Secretary’s Advisory Committee for Human Research Protections (SACHRP), to be sworn in at the upcoming July 19-20 meeting. The new members are:
- Albert J. Allen, M.D., Ph.D. Senior Medical Fellow Bioethics & Pediatric Capabilities Global Medical Affairs and Development Development Center of Excellence Eli Lilly & Co
- Gary L. Chadwick, Pharm.D., M.P.H., C.I.P. Associate Provost and Director Office for Human Subject Protection University of Rochester
- Susan Krivacic, M.P.Aff. Principal and Consultant PBG Consulting LLC
- Suzanne M. Rivera, Ph.D., M.S.W. Associate Vice President for Research Case Western Reserve University
OHRP would like to extend sincere thanks to all those who applied for SACHRP membership, and notes that nominees will again be solicited in early 2012. For further information on SACHRP, please see http://www.hhs.gov/ohrp/sachrp/index.html
(June 27, 2011) Revised Frequently Asked Questions and Answers on the Assurance Process
OHRP has posted on its website a revised set of Frequently Asked Questions and Answers (FAQs) on the Assurance Process that can be accessed at: http://answers.hhs.gov/ohrp/categories/1563. These FAQs include information on recent changes in the Federalwide Assurance (FWA) form and Terms of Assurance, which have been approved by the Office of Management and Budget (OMB). On June 21, OHRP sent out a list serve notification announcing the availability of the OMB-approved revised FWA form and Terms. That notification lists the key changes in the form and terms and can be accessed at: http://www.hhs.gov/ohrp/newsroom/announcements/2011.html#20110620.
(June 20, 2011) OMB Approval of the Federalwide Assurance (FWA) Form, Terms of the FWA, and Related Documents
The Office for Human Research Protections (OHRP) is pleased to announce the availability of the revised Federalwide Assurance (FWA) form, Terms of Assurance and related documents, which have been approved by the Office of Management and Budget (OMB).
On September 23, 2010, OHRP published a Federal Register notice to solicit public comment on several proposed changes to the FWA and Terms that would simplify and shorten the FWA form and Terms of Assurance approved for use by OMB through May 31, 2011, under Control Number 0990-0278. Six individuals and two organizations submitted comments on the proposed changes; the majority supported the proposed changes.
The revised OMB-approved FWA form and terms of Assurance have been approved for use through June 30, 2014 and adopted the changes in the FWA form and terms of assurance largely as proposed in the September 2010 notice. The key changes in the revised form and terms are the following:
(i) The revised FWA form replaces a prior requirement that all IRBs (both internal and external IRBs) relied upon by the institution be specifically designated with a requirement that only internal IRBs be specifically designated or that, if an institution does not have an internal IRB, only one external IRB be specifically designated. All IRBs must be registered with OHRP before they can be designated on an OHRP-approved FWA;
ii) The revised FWA form allows the FWA to be signed electronically by the institution’s signatory official, eliminating the prior need for submission of a hard-copy signature page by mail or facsimile. OHRP now require that institutions submit all FWAs (including new submissions, updates, and renewals) using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability to do so electronically. If an institution believes it lacks the ability to submit its FWA electronically, it must contact OHRP by telephone or email and explain why it is unable to submit its FWA electronically;
(iii) The standard period of approval for an FWA is increased from a 3-year period to a 5-year period;
(iv) The prior separate FWA forms for U.S. and non-U.S. institutions are combined into a single form that will still collect the same basic information previously requested in the separate forms, except as noted in items (i) and (vii);
(v) The Terms of Assurance document is shortened and simplified. In the prior version, some portions of the text appeared twice; those duplications were eliminated by re-organizing portions of the document. In addition, there were several items covered in the prior version that OHRP no longer sees as necessary to include, or which are addressed in the FWA form itself. These items have been eliminated from the Terms of Assurance document;
(vi) International institutions no longer have a separate FWA form or separate Terms of Assurance; and,
(vii) The revised FWA form no longer requests submission of the HHS Institution Profile code or the Federal Entity Identification number;
The OMB-approved revised FWA documents are posted on OHRP’s website at: http://www.hhs.gov/ohrp/assurances/forms/index.html
REGISTER NOW for an upcoming OHRP Research Community Forum entitled, "Protecting Human Subjects: Blending Regulatory Requirements and Best Practices,” on June 21, 2011 in Boston, Massachusetts.
Lead sponsor for the Forum is Dana-Farber Cancer Institute.
REGISTRATION FEE REDUCED - $75
(March 14, 2011) Save-the-Date for the OHRP Research Community Forum entitled "Protecting Human Subjects: Blending Regulatory Requirements and Best Practices” sponsored by Dana-Farber Cancer Institute in Boston, Massachusetts on June 21, 2011.