Skip Navigation
  • Text Size: A A A
  • Print
  • Email
  • Facebook
  • Tweet
  • Share
  • Print
  • Email
  • Facebook
  • Tweet
  • Share

Announcements for 2014

 

(October 24, 2014) OHRP Announces the Availability of Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

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for Health, Department of Health and Human Services (HHS), announced in the Federal Register the availability of a draft guidance document entitled, "Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care," and are inviting public comments on that document. The draft guidance pertains to nonexempt research involving human subjects designed to evaluate treatments or procedures that are medically recognized standards of care.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The draft guidance explains how to apply the HHS Regulations at 45 CFR Part 46 to studies that are designed to evaluate one or more standards of care.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The draft guidance addresses the following topics: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The draft guidance, when finalized, will provide OHRP’s first formal guidance on this topic.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 from the OHRP website's Requests for Comments page.

 

 

(October 16,2014) OHRP has posted its correspondence with  the director of a national health registry

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 here

 

(September 24, 2014) OHRP announces appointment of new Deputy Director

The Office for Human Research Protections (OHRP) is pleased to announce that Julie Kaneshiro has been promoted to the position of Deputy Director of OHRP, effective October 5, 2014.  Ms. Kaneshiro joined OHRP in 2002, and previously served as the Policy Team Leader and Senior Policy Analyst in OHRP’s Division of Policy and Assurances.  Before coming to OHRP, she held various positions at the National Institutes of Health.  She has a Master of Arts Degree in Public Policy from George Washington University, and a Bachelor of Arts degree from the University of Maryland.

 

(September 12, 2014) OHRP announces new SACHRP members

The Office for Human Research Protections (OHRP) would like to announce three new members who have been invited to join the Secretary's Advisory Committee on Human Research Protections (SACHRP). The invited members are:

       •    Diana T. Chingos, M.S., M.F.A.
                Executive Director, Noreen Fraser Foundation

       •    Holly Fernandez-Lynch, J.D., M. Bioethics
                Executive Director, Petrie-Flom Center for Health Law Policy,
                Biotechnology, and Bioethics, Harvard Law School

       •    Reed E. Pyeritz, M.D., Ph.D.
                Professor of Medicine & Professor of Genetics
                Vice-chair for Academic Affairs, Department of Medicine
                Senior Fellow, Leonard Davis Institute of Health Economics
                Perelman School of Medicine, University of Pennsylvania

 

OHRP would like to thank all applicants, and notes that the next SACHRP member solicitation will be published in the Federal Register in approximately six months. Please note that the next SACHRP meeting is scheduled for October 29 and 30th at the Fishers Lane Conference Center, 5635 Fishers Lane, Rockville, MD 20852.

 

(May 19, 2014) HHS posts vacancy for position of Health Science Administrator (Deputy Director, OHRP)

The Office for Human Research Protections (OHRP) is pleased to announce the following job vacancy within the Office of the Assistant Secretary for Health (OASH). OHRP is actively seeking to fill a vacancy for its Deputy Director.

Series and Grade: GS-0601-15

Salary Range: $124,995.00 to $157,100.00 Per Year

Announcement numbers: HHS-OASH-DE-14-1120493; HHS-OASH-MP-14-1120495

What's the closing date for applications? Friday, June 13, 2014

Who May Apply?United States Citizens, HHS-OASH-DE-14-1120493; Status Candidates (Merit Promotion and VEOA Eligibles, Noncompetitive eligibles, PHS Commissioned Corps Officers), HHS-OASH-MP-14-1120495

Position: Health Science Administrator (Deputy Director, OHRP)

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS), you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

This position is located in the Office of the Secretary, OASH, OHRP.

OHRP provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

How to apply: Depending on your status, you can apply for this position at one or the other of the following links on the USAJobs website:

HHS-OASH-DE-14-1120493: https://www.usajobs.gov/GetJob/ViewDetails/369942700
HHS-OASH-MP-14-1120495: https://www.usajobs.gov/GetJob/ViewDetails/369940300

 

(April 22, 2014) ORISE policy fellowship opportunity available in OHRP

An Oak Ridge Institute for Science and Education (ORISE) policy fellowship opportunity is currently available in the Division of Policy and Assurances, Office for Human Research Protections (OHRP), within the Office of the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS).

Qualified persons who have earned a Bachelor’s, Master’s or Doctorate degree in public health, public policy, law or science within the last five years are encouraged to apply for this opening. Experience in writing papers that address specific aspects of the protection of human subjects in biomedical and behavioral research is a plus.

The Research Participation program for HHS is administered by ORISE. The initial appointment is for one year, but may be renewed upon recommendation of OHRP contingent on the availability of funds and project needs.

The policy fellowship announcement (DHHS-OHRP-2014-0111) and how to apply can be found at: http://www.orau.org/science-education/internships-scholarships-fellowships/description.aspx?JobId=14704

 

(April 5, 2014) Updated: HHS, OASH posts two job announcements for GS-685-09/11 Public Health Advisor positions for a few vacancies in the Washington, DC and Rockville, MD Areas

These positions may be located in any of the offices reporting to the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services (DHHS), with vacancies in Washington, DC and Rockville, MD, including in the Office for Human Research Protections (OHRP). 

The mission of OASH is management oversight of 12 core public health offices — including OHRP — as well as 10 regional health offices across the nation and 10 Presidential and Secretarial advisory committees.

OHRP considers work experience related to human research subject protection programs to be work experience in the area of public health programs, and encourages applicants to include this information in their responses to the questionnaire, if applicable.

Series and Grade: GS--0685-09/11

Job Title: Public Health Advisor

Salary Range:  $52,146.00 to $82,019.00 / Per Year

Announcement numbers:  HHS-OASH-DE-14-1086904; HHS-OASH-DE-14-MP-14-1086899

Closing date for applications: Wednesday, April 16, 2014

Who May Apply:  United States Citizens ,HHS-OASH-DE-14-1086904, ; and, Status Candidates Candidates (Merit Promotion and VEOA eligibles, PHS Commissioned Corps Officers), HHS-OASH-DE-14-MP-14-1086899

How to apply:  Depending on your status, you can apply for this position at one or the other of the following links on the USAJobs website:

HHS-OASH-DE-14-1086904 under delegating examining procedures: https://www.usajobs.gov/GetJob/ViewDetails/365936400

HHS-OASH-DE-14-MP-14-1086899 under merit promotion procedures: https://www.usajobs.gov/GetJob/ViewDetails/365935700

 

(April 4, 2014) Updated: HHS, Office of the Secretary, Office of the Assistant Secretary for Health posts two job announcements for Public Health Advisor positions for many vacancies in the Washington, DC and Rockville, MD Areas

These positions may be located in any of the offices reporting to the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services (DHHS), with vacancies in Washington, DC and Rockville, MD, including in the Office for Human Research Protections (OHRP).  OHRP is particularly interested in filling vacancies in its Division of Policy and Assurances and its Division of Education and Development. 

The mission of OASH is management oversight of 12 core public health offices — including OHRP — as well as 10 regional health offices across the nation and 10 Presidential and Secretarial advisory committees.

OHRP considers work experience related to human research subject protection programs to be work experience in the area of public health programs, and encourages applicants to include this information in their responses to the questionnaire, if applicable.

Series and Grade: GS--0685-12/13

Job Title: Public Health Advisor

Salary Range:     $75,621.00 to $116,901.00 / Per Year

Announcement numbers:  HHS-OASH-MP-14-1078162; HHS-OASH-DE-14-1078257

Closing date for applications: Tuesday, April 15, 2014

Who May Apply:  Status Candidates (Merit Promotion and VEOA Eligibles, Noncompetitive Eligibles, PHS Commissioned Corps Officers

How to apply: Depending on your status, you can apply for this position at one or the other of the following links on the USAJobs website:

HHS-OASH-MP-14-1078162 under merit promotion procedures: https://www.usajobs.gov/GetJob/ViewDetails/364976300

HHS-OASH-DE-14-1078257 under delegating examining proceudres: https://www.usajobs.gov/GetJob/ViewDetails/364976500

 

January 3, 2014 - HHS posts vacancy for position of Director of the Division of Education and Development in OHRP.

The Office for Human Research Protections (OHRP) is pleased to announce the following job vacancy within the Office of the Assistant Secretary for Health (OASH), including OHRP. OHRP is actively seeking to fill a vacancy for the Director of its Division of Education and Development.

Series and Grade: Public Health Advisor, GS--0685-15

Salary Range: $124,995.00 to $157,100.00 / Per Year

Announcement numbers: HHS-OASH-DE-14-1021509; HHS-OASH-MP-14-1020472.

What's the closing date for applications? Friday, January 31, 2014.

Who May Apply? This is a competitive vacancy, open to all United States citizens.

Position: Director, Division of Education and Development

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

This position is located in the Department of Health and Human Services (HHS), Office of the Secretary (OS), Office of the Assistant Secretary for Health (OASH), Office for Human Research Protections (OHRP), Division of Education and Development in Washington, DC.

The Division of Education and Development enhances the protection of human subjects in HHS-conducted or supported research by providing education to individuals involved in the human subjects research enterprise. Specific Division functions include conference coordination, quality assessment, promotion of cooperative education and development, provision of ethical guidance and clarification, and maintenance and promulgation of educational and institutional review guidance materials.

How to apply: Depending on your status, you can apply for this position at one or the other of the following links on the USAJobs website:

HHS-OASH-DE-14-1021509: https://www.usajobs.gov/GetJob/ViewDetails/358308800
HHS-OASH-MP-14-1020472: https://www.usajobs.gov/GetJob/ViewDetails/358308900