CR Industry News

New SACHRP members announced

The Office for Human Research Protections announced in late June, 2011, the selection of four new members of the Secretary's Advisory Committee for Human Research Protections (SACHRP). They were scheduled to be sworn in at the upcoming July 19-20 meeting.

The new members include the following:

  • Albert J. Allen, MD, PhD, senior medical fellow, bioethics & pediatric capabilities, global medical affairs and development, Development Center of Excellence at Eli Lilly & Co;
  • Gary L. Chadwick, PharmD, MPH, CIP, associate provost and director, office for human subject protection, University of Rochester;
  • Susan Krivacic, MPAff, principal and consultant, PBG Consulting LLC;
  • Suzanne M. Rivera, PhD, MSW, associate vice president for research, Case Western Reserve University;

OHRP will solicit additional nominees in early 2012. For further information on SACHRP, visit the website: http://www.hhs.gov/ohrp/sachrp/index.html.

OHRP answers CR sites' questions about FWA

The Office for Human Research Protections (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

Here is a sample of the FAQs developed by OHRP:

• What assurance of compliance process for human subject protection is accepted by the Office for Human Research Protections (OHRP) and other Federal agencies?

The Health and Human Service (HHS) human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to OHRP. The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP. FWAs also are approved by the Office for Human Research Protections (OHRP) for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.

• What is an assurance of compliance with human subject protection regulations?

An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by HHS. Through the assurance of compliance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45 CFR part 46. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.

• When does a research institution need to be covered by an assurance of compliance with human subjects research protections?

All institutions engaged in human subjects research that is not exempt from the regulations, and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections-approved assurance of compliance (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html). The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.

An institution may extend its FWA to cover a collaborating individual investigator under certain conditions using the sample Individual Investigator Agreement or a comparable agreement developed by the institution.

• When is an institution considered to be "engaged in research"?

In general, an institution is considered to be engaged in human subjects research when its employees or agents:

(1) obtain data about living individuals for research purposes through intervention or interaction with them;

(2) obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102; or

(3) obtain the informed consent of human subjects.

Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.

In general, an institution is considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution. In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research. However, obtaining informed consent from a research participant is considered engagement in research. [For details, please see OHRP guidance on this topic at: http://www.hhs.gov/ohrp/policy/engage08.html, specifically, Section (B)(4).]

• What is a Federalwide Assurance (FWA)?

The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.

FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.

There is a single version of the FWA and the Terms of Assurance for domestic (U.S.) institutions and international (non-U.S.) institutions.

• What research does the Federalwide Assurance (FWA) cover?

The FWA covers all non-exempt human subjects research at the submitting institution that is HHS-conducted or -supported or funded by any other federal department or agency that has adopted the Common Rule and relies upon the FWA. It is not project specific. Domestic institutions may voluntarily extend their FWA to cover all human subjects research at the submitting institution regardless of the source of support for the particular research activity.

• What time period does the Federalwide Assurance (FWA) cover and when does it have to be updated?

The Federalwide Assurance (FWA) is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA. The institution must update its FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official. Any renewal or update that is submitted electronically, and approved by OHRP, begins a new 5-year effective period.