Announcements for 2013
December 3, 2013 - 2014 Edition of International Compilation of Human Research Standards Now Available
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:
- General Research
- Drugs and Devices
- Research Injury
- Privacy/Data Protection
- Human Biological Materials
- 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.
November 4, 2013 - SACHRP soliciting member nominations
OHRP is soliciting nominations to fill three positions for membership on the Secretary’s Advisory Committee on Human Research Protection (SACHRP). For information and instructions regarding how to apply, please see: http://www.gpo.gov/fdsys/pkg/FR-2013-11-04/pdf/2013-26291.pdf; or, http://www.gpo.gov/fdsys/pkg/FR-2013-11-04/html/2013-26291.htm. Note: if you submitted a nomination in response to the solicitation request posted in the Federal Register on September 27, 2013, you do not need to resubmit your nomination. The following information should be included in the package of material submitted for each individual being nominated for consideration: (1) a letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes which qualify the nominee for service in this capacity), and a statement that the nominee is willing to serve as a member of the Committee; (2) the nominator’s name, address, daytime telephone number, and the home and/or work address, telephone number, and email address of the individual being nominated; and (3) a current copy of the nominee’s curriculum vitae. Nominees may self-nominate. All nominations must be received by December 4, 2013. For further information contact SACHRP Executive Director Julia Gorey at Julia.firstname.lastname@example.org.
September 23, 2013 - OHRP revises its response to the question “When does compensating subjects undermine informed consent or parental permission?”
OHRP has revised its response to the Frequently Asked Question (FAQ) “When does compensating subjects undermine informed consent or parental permission?” (http://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).
Human subjects often are provided payment for their time, inconvenience, and out-of-pocket expenses. Remuneration for risk, however, has been a source of controversy because it is challenging to assign a reasonable level of payment and because it is difficult to assess what constitutes undue influence. In reality, however, many subjects would not participate in research involving risk absent some level of remuneration.
The previous version of the response to this FAQ included the following sentences. “In no case should remuneration be viewed as a way of offsetting risks; that is, it should not be considered a benefit to be weighed against study risks. The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration.”
The first sentence has been struck because this FAQ focuses on potential undue influence in the consent process (45 CFR 46.116) rather than on IRB considerations under 45 CFR 46.111. However, OHRP continues to assert that IRBs should not consider remuneration as a way of offsetting risks.
With regard to the second sentence, several members of the research ethics community have brought to our attention the implication of these sentences, which is that in most cases any level of remuneration based on research risks could be considered unacceptable. This implication is not consistent with OHRP’s interpretation of 45 CFR 46.116. In deciding whether to participate in research, subjects should have the opportunity to assess when risks and benefits (including remuneration) are balanced in light of their individual circumstances. Thus, the second sentence referenced above has been struck from the response.
In addition, the previous version contained the following sentence, which has been struck because it is focused on IRB considerations under 45 CFR 46. 111 rather than on informed consent, and was misplaced in this FAQ: “IRBs may need to request of the investigator some plan for monitoring subject recruitment to ensure that such inducements do not result in inequitable subject recruitment (e.g., recruiting only economically disadvantaged individuals).”
In sum, this FAQ has been changed to clarify that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research. It has also been revised to focus more specifically on issues related to consent.
Other minor changes have been made for clarity.
If you have specific questions regarding the issues discussed in this FAQ, please 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.
September 9, 2013 - HHS August 28, 2013 Public Meeting on Human Subject Protections – Transcripts are Available and Presentations can be Viewed
Transcripts of the August 28, 2013 HHS Public Meeting on Matters Related to Protection of Human Subjects and Research Considering Standard of Care Interventions have been posted. The transcripts were created by OHRP staff from the video captions and can be accessed from the Spotlight section of OHRP’s home page http://www.hhs.gov/ohrp/. Videos of that meeting can also be accessed from that site.
August 21, 2013-Information on viewing the August 28, 2013 HHS Public Meeting on Protections of Human Subjects and Research Studying Standard of Care Interventions
For those who cannot attend the August 28, 2013 HHS Public Meeting on the Protections of Human Subjects and Research Studying Standard of Care Interventions, HHS is providing an option to view the public meeting via live streaming technology. To view the HHS public meeting live on August 28, 2013, go to the HHS live streaming site at: www.HHS.gov/live then hit the“Click to Play” arrow. Additional information about the August 28, 2013 meeting can be found at: http://www.hhs.gov/ohrp/newsroom/rfc/Public%20Meeting%20August%2028,%202013/aug28public.html
June 26, 2013 - HHS Announces August 28, 2013 Public Meeting
On June 26, 2013, the Department of Health and Human Services (HHS) announced in the Federal Register an August 28, 2013 public meeting to seek public input and comment on how certain provisions of the Federal policy for the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context. HHS specifically requests input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.
HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large. The meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects. HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.
The public meeting will be held on August 28, 2013, from 9 a.m. to 5 p.m., in the Hubert H. Humphrey Building, 200 Independence Ave., SW, Great Hall, Washington, DC 20201; Metro: Federal Center SW station.
Deadline for Registering to Attend the Pubic Meeting:
While there is no registration fee, individuals planning to attend the public meeting in person must register to attend. Registration to attend the meeting will be accepted on a first-come, first-served basis and must be received no later than 5 p.m. on August 14, 2013. Due to space limitations, the number of registrants will be capped.
Deadline for Registering to Present at the Public Meeting:
Registration to present at the public meeting will be accepted on a first-come, first-served basis and must be received no later than 5 p.m. on August 7, 2013.
Deadline for Submitting Comments for the Public Meeting:
Written comments for discussion at the public meeting must be received no later than 5 p.m. on August 7, 2013.
Deadline for Submitting Comments after the Public Meeting:
In addition to materials submitted for discussion at the public meeting, individuals may submit other written comments after the public meeting. These comments must be received no later than 5 p.m. on September 9, 2013 for consideration by HHS.
An alternative to attending the meeting in person will be provided. Participants who cannot attend the public meeting in person will have an option to view it via live streaming technology. Information on that option will be posted at a later time on the OHRP website at http://www.hhs.gov/ohrp.
The Federal Register notice announcing the public meeting and details about the following: registering to attend, registering to present at the meeting, submitting written comments, viewing the public meeting via live streaming, issues for discussion, special accommodations, and, additional background information, can be accessed at: http://www.hhs.gov/ohrp/newsroom/rfc/Public%20Meeting%20August%2028,%202013/aug28public.html
January 29 2013 - OHRP Fellowships in Compliance Oversight and Policy - Accepting Applications
The Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) has two openings for qualified persons who have earned a Bachelor’s, Master’s or Doctorate degree in public health, public policy, science, law, ethics, philosophy, or related fields. One opening in OHRP is for a compliance oversight fellow (DHHS-OHRP-2013-0102) and the second is for a policy fellow (DHHS-OHRP-2013-0103). 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 two announcements are on the website of the Oak Ridge Institute for Science and Education (ORISE) which manages the fellowship program for HHS.
Interested persons can find these announcements by going to the ORISE website: http://orise.orau.gov/about-orise/default.aspx, and entering, in the Search field, the compliance oversight announcement number: DHHS-OHRP-2013-0102, or the policy announcement number: DHHS-OHRP-2013-0103.