RSVP Now for 9/22/2011 PRIM&R Webinar on Improving Informed Consent

Please join the Office for the Protection of Human Subjects (OPHS) for a PRIM&R webinar on this timely topic:

What: Improving Informed Consent: Innovations in Form and Process
When: Thursday, September 22, 2011 from 10:00 AM to 11:30 AM
Where: Large Conference Room, RAC Offices (2150 Shattuck Ave, Suite 300)

Space is limited. Reservations will be taken on a first-come, first-served basis. Register for this free webinar by emailing OPHS@berkeley.edu and reserving your place. (A waiting list will be maintained.) For more information, contact Louise Tipton, IRB Administrator, via 642-7461 or emailing OPHS.

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Additional information:

How can you ensure that obtained consent is truly informed?

Informed consent is a vital component of ethical research. The professional organization Public Responsibility in Medicine and Research (PRIM&R) is proud to offer an advanced level webinar titled Improving Informed Consent: Innovations in Form and Process, on September 22, 2011, from 10:00 to 11:30 AM PST.

Topics for discussion will include:

• Tensions between an optimally written form and a quality consent process: striking the appropriate balance
• Regulatory constraints associated with limited English language proficiency and low-literacy populations: preparing to meet the needs of these groups
• Innovations in consent forms: using the Short Form and exploring developments by the Association of American Medical Colleges (AAMC) and National Cancer Institute (NCI) working groups
• A case study on oral consent: identifying common assumptions about comprehension and assessing the subjects’ understanding
• A case study on institutional review board (IRB) review of a consent form: identifying IRB responsibilities, including ensuring consistency between the consent form and consent process.

Campus Invited to UC Teleconference on 9/2/2011: DHHS Advanced Notice of Proposed Rule Making on Human Subject Protections

The Department of Health and Human Services has issued an Advanced Notice of Proposed Rule Making (ANPRM) as the first step in revising the Common Rule (45 CFR 46), the code of federal regulations governing research with human subjects. These changes could greatly impact the IRB review process and requirements. The ANPRM requests comments on how current regulations might be modernized and revised to be more effective and how to better protect subjects while facilitating research and reducing burden, delay, and ambiguity for investigators. The comment period on this proposal has been extended by 30 days and will end on October 26, 2011.

You are invited to help develop UC’s institutional comments on the ANPRM via a series of organized teleconference calls. The last one-hour teleconference call is scheduled for this Friday, September 2nd at 3PM and is open to the general UC research community. The discussion will focus on the proposed changes to the regulations pertaining to data collection, oversight and harmonization. In order to collect input and focus the discussion, a survey has been created with the Advanced Notice questions pertaining to these topics.

Note: This is the last of the three surveys distributed. However, all three surveys will remain open until September 16th, so if you haven’t provided comments to the previous two surveys, you are encouraged to do so.

Previous weeks’ surveys:
Survey #1, “Risk Based Protections”
Survey #2 “Consent”

Log-in information for the conference call is as follows:
Call-in #: 866-740-1260; Access Code: 9870688.
PowerPoint slides for the discussion can be accessed by logging into www.readytalk.com and entering 9870688 as your access code.

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September 9, 2011 Update:

As previously announced, UC’s Office of the President invited the research community to help develop institutional comments via three surveys and related conference calls. Although the conference calls are now complete, all three surveys will remain open until Friday, September 16, 2011. You are welcome to contribute your input.

Survey #1 - “Risk Based Protections”
Survey #2 - “Consent”
Survey #3 - “Data Collection, Oversight, and Harmonization”

FY 2011 Sponsored Projects Annual Report Published

The Sponsored Projects Office Annual Report, Fiscal Year 2011, is now available on the SPO web site. The report provides information on campus proposals and awards during the past fiscal year; in fiscal year 2011, the Berkeley campus received $717.3 million in contract and grant awards.

RCR Training at UC Berkeley for NIH Grants

In 2009, the National Institutes of Health updated its policy for instruction of trainees in the Responsible Conduct of Research (RCR). The revised policy, Update on the Requirement for Instruction in the Responsible Conduct of Research, states: “NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.”

RCR Training at UC Berkeley

Online training alone is not acceptable to NIH. There are several options at UC Berkeley for RCR training; trainees may choose what is best for their goals and schedules. Two training options are listed here. Some departments and graduate groups also have their own courses.

1. Responsible Conduct of Research Seminar Series
This year-long, 12-part seminar series, Seminars on the Responsible Conduct of Research, is offered to the UC Berkeley campus as an alternative to traditional courses that offers a flexible way to receive training in RCR. The seminar series provides an opportunity to interact with people who are involved in research at many different levels, from students to faculty to staff and administration. This series is sponsored by the Office of the Vice Chancellor for Research, Research Enterprise Services, and the Center for Computational Biology. Attendees who participate in a minimum of eight sessions will receive a Certificate of Completion at the conclusion of the series. Graduate students, postdoctoral scholars, faculty members, and staff members are invited to attend.
Update: Due to high demand and limited space, please RSVP for these seminars, specifying which Fall Semester seminar(s) you hope to attend. All seminars are scheduled to take place from noon-1:00 pm in 177 Stanley Hall, but may be moved to a larger location; please check the schedule for updates. The first seminar is September 12, 2011.

2. UC Berkeley Extension
UC Berkeley Extension and the UC Berkeley Office of the Vice Chancellor for Research are offering free training this fall, on campus, for eligible applicants: UC Berkeley Required Training in the Responsible Conduct of Research for NIH. Training applications for the fall term are due by August 30, 2011. Additional training will be offered in 2012 for applicants with later grant review deadlines.

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More information on UC Berkeley RCR training for both NIH and for National Science Foundation research projects is available at Required Responsible Conduct of Research (RCR) Training on the Research Administration and Compliance web site.

NIH Revises Financial Conflict of Interest Regulations

The Department of Health and Human Services has issued a final rule, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” that revises the regulations on disclosing and reporting conflicts of interest. The final rule amends the PHS regulations issued in 1995 “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” and “Responsible Prospective Contractors.”

The new regulations maintain the general framework of the 1995 regulations, but make some significant changes.

In particular, the new regulations:

• Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
• Lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
• Require institutions to report to the PHS Awarding Component additional information on identified financial conflicts of interest and how they are being managed.
• Require institutions to make certain information accessible to the public concerning identified financial conflicts of interest held by senior/key personnel.
• Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.

Institutions applying for or receiving National Institutes of Health or other PHS funding from a grant, cooperative agreement, or contract that is covered by the final rule must be in full compliance with all of the revised regulatory requirements by August 24, 2012. In the interim, or until the institutional financial conflict of interest policy is revised and published, institutions should continue to comply with the 1995 regulations.

The UC Office of the President and the UC campuses will be working on revising UC policy for disclosure of financial interests, and UC Berkeley policy and procedures will be changed accordingly and available on the UC Berkeley Conflict of Interest web site.

Resources:

• UC Berkeley Conflict of Interest web site
  
• NIH OER Financial Conflict of Interest web page
• Federal Register (8/25/2011): Final Rule Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
• NIH Guide Notice (8/23/2011): Issuance of the Final Rule - Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
• Sally Rockey NIH blog post: Charting a Renewed Course for Managing Financial Conflicts of Interest
• NIH news (8/23/11): HHS Tightens Financial Conflict of Interest Rules for Researchers

Campus Invited to UC Teleconference on 8/26/2011: DHHS Advanced Notice of Proposed Rule Making on Human Subject Protections

The Department of Health and Human Services has issued an Advanced Notice of Proposed Rule Making (ANPRM) as the first step in revising the Common Rule (45 CFR 46), the code of federal regulations governing research with human subjects. These changes could greatly impact the IRB review process and requirements.

You are invited to help develop UC’s institutional comments on the ANPRM via several organized teleconference calls. The first of two upcoming one-hour teleconference calls is scheduled for this Friday, August 26 at 3PM and is open to the general UC research community. The discussion will focus on the proposed changes to the regulations pertaining to informed consent. In order to collect input and focus the discussion, a survey has been created with the Advanced Notice questions pertaining to consent.

Log-in information is as follows:
Call-in #: 866-740-1260; Access Code: 9870688.
PowerPoint slides for the discussion can be accessed by logging into www.readytalk.com and entering 9870688 as your access code.

OMB Asks Federal Agencies to Plan 2013 Budgets with 5 and 10 Percent Cuts

The White House Office of Management and Budget has issued memo M-11-30, Fiscal Year 2013 Budget Guidance to heads of federal departments and agencies asking for budgets for 2013 that are 5 and 10 percent below this year’s discretionary spending levels.

OMB Director Jack Lew provides additional comments in an OMB blog post: 2013 Budget Guidance.

“In light of the tight limits on discretionary spending starting in 2012, we asked agencies for budget submissions that provide options to support the President's commitment to cut waste and re-order priorities to achieve deficit reduction while investing in those areas critical to job creation and economic growth. To meet this goal, we asked agencies to provide budgets based on two scenarios: a 5 percent cut and a 10 percent cut from the 2011 enacted discretionary level.”

The memo also asks agencies to identify cost-saving mechanisms to increase efficiency and reduce duplication and to identify opportunities to spur economic growth and job creation.

SPO Update: Revised PRF and Late Proposal Form

Over the summer changes were made to two of the forms used by the campus community. Please use the new versions of these forms as soon as possible to improve the efficiency of our campus processes.

The VCR Late Proposal Approval Request Form has been redesigned and updated. The new version of this form was made available to the campus on 7/14/2011. It should now be used by all campus units. The revised form makes it possible for Principal Investigators to indicate to the Vice Chancellor for Research Office if the proposal is in response to a published (hard) vs. an unpublished (soft) deadline. This distinction will better inform the approval process.

The Sponsored Projects Office Proposal Review Form (PRF) also has been modified. Two important changes have been made:

1. A new check box has been added to indicate if “program income” is anticipated.

Program Income is income earned or generated by a sponsored project. Some examples of potential sources of program income include fees from participants at conferences or symposia, sale of items created or fabricated with project funds, and fees for services performed such as laboratory tests. Such income is subject to the terms and conditions of the sponsor, and it is the PI’s responsibility to ensure the funds generated by the project are treated according to the sponsor’s requirements. This modification to the PRF will allow better tracking of potential program income across campus.

2. The signature section of the PRF has been modified.

Chair/Dean approvers for Co-PIs now are no longer required to sign the PRF. Instead, departments/units will be required to provide the name and contact information for the Chair/Dean and this individual will be included on the distribution list of persons receiving notification about the proposal’s submission.

If cost sharing from the Co-PI’s department/unit is included or if the Co-PI is proposing release time as part of the proposal, SPO will require additional approvals from the Co-PI’s Chair/Dean.

Note: Signatures from the PI and the Co-PI still must be provided on the PRF. The PI’s Chair/Dean also still must sign the PRF. These signatures are needed to confirm the certification statements about the content of the proposal and responsibility for the proposal should it be funded.