Research Advocate

RAC Offices to Close During the Annual Campus Winter Break

2009-11-06T15:12:00.000-08:00

The Animal Care and Use Committee Office, the Office for the Protection of Human Subjects, the Sponsored Projects Office, and the Research Administration and Compliance Office will be closed during the campus energy curtailment beginning Wednesday, December 23, 2009 through Wednesday, January 6, 2010. Offices will reopen on Thursday, January 7, 2010.

SPO Proposal Submission

SPO will process proposals due in December and January according to the VCR’s five-day proposal submission policy with the following exceptions:

For proposals with deadlines that fall between December 23 and January 8th, the due date to SPO will be no later than Wednesday, December 16, 2009.
For proposals due January 11th-13th, the due date to SPO will be no later than noon on Monday, December 21, 2009.
SPO will not accept proposals after noon on Monday, December 21, 2009.

To assist Berkeley faculty and staff members who need to submit proposals before and/or after the holiday/furlough period SPO will extend its drop box hours from 7 am to 6 pm from December 9th to the 18th. SPO will collect proposals from the drop box each day at 6 pm. These proposals then will be logged in on this date. A SPO Research Analyst also will be available to answer general proposal questions from 7 to 8 am and 5 to 6 pm each day during this same time period. Persons needing assistance from 7 to 8 am and 5 to 6 pm should call the main SPO number: 642-0120.

PIs also are encouraged to inform their SPO Research Analyst if they will be submitting a proposal with a due date just prior to, during, or just after the curtailment period. This will give SPO and the PI an opportunity to discuss the best way to handle the proposal to make sure it is submitted in a timely manner.

ACUC Protocol Submission

Please note that all protocols and protocol revisions must be submitted via email to: ACUC@berkeley.edu by 5 pm on the deadline date.
If you wish to make changes to an approved protocol, you must first contact the ACUC office to obtain a copy of the current approved version of your protocol. Failure to do so may result in your protocol being returned to you.
The deadline for protocol submission for the January 20, 2010 meeting is Monday, November 16, 2009.
The deadline for protocol submission for the February 17, 2010 meeting is January 5, 2010. No exceptions to this deadline will be granted as ACUC staff must process all protocols for the February meeting by end of business on January 6, 2010.

CPHS Protocol Submission

The deadline for protocol submission for the December 4, 2009 CPHS-I meeting is Monday, November 9, 2009.
The deadline for protocol submission for the December 18, 2009 CPHS-II meeting is Monday, November 23, 2009.
There is no CPHS-I meeting in January 2010; the deadline for protocol submission for the February 5, 2010 CPHS-I meeting is Monday, January 11, 2010. Please note that any new protocol to be reviewed at this meeting must be submitted via eProtocol.
The deadline for protocol submission for the January 22, 2010 CPHS-II meeting is Friday, December 18, 2009. (Please note this is an earlier deadline than usual).
Important: if your study is “greater than minimal risk” needing full board review and the approval will expire before January 22, 2010, you must submit your renewal application in time for review at a December 2009 CPHS meeting.
No deliveries will be accepted after noon on December 22, 2009; any documents left in the drop box over the break will not be retrieved and logged until January 7, 2010.
eProtocol Announcement: OPHS anticipates that as of December 18, 2009 investigators will be required to submit ALL NEW PROTOCOLS via eProtocol, therefore no paper-based submissions for new protocols will be accepted after NOON on Friday, December 18, 2009. Please check the CPHS website for updates or changes to this deadline.

In addition, for protocols determined to be exempt prior to July 1, 2009 if an investigator wants to make a modification or revision to his/her protocol then s/he must re-submit the exempt protocol via eProtocol as a “new” project and incorporate the amendment into the protocol application. Please include a reference in the narrative to the original exempt determination CPHS# and append the “old” determination of exemption approval letter to the submission. See the CPHS web site for more detail about eProtocol submissions.

Berkeley eProtocol for Human Subjects Research: Required for All Exempt Protocols on July 1

2009-06-11T11:25:00.000-07:00

Berkeley eProtocol is a user-friendly, online system for submitting, tracking, reviewing, and approving CPHS human subject research protocols. After a successful pilot testing phase CPHS and OPHS are ready to fully implement this paperless submission process for all exempt level protocol submissions beginning July 1, 2009!

To submit an exempt protocol via Berkeley eProtocol go to: http://cphs.berkeley.edu/content/eprotocolpilot.htm.

Paper-based (hard copy) submissions of exempt applications received on or after July 1, 2009 will be returned to the investigator. OPHS encourages investigators who may be submitting their exempt applications in late June 2009 to use eProtocol instead of paper.

What is Exempt Research?
For information about what it means to qualify as exempt, categories, and examples of exempt research, see the CPHS Guidelines in Exempt Research at: http://cphs.berkeley.edu/content/exempt.htm.

Question and Comments
If you have any questions or comments about the new Berkeley eProtocol system, please contact OPHS Director Rebecca Armstrong at rda@berkeley.edu or OPHS eProtocol project manager Maria Savage at mcsavage@berkeley.edu.

March 20 Research Advocate article: Berkeley eProtocol for Human Subjects Research Goes Live!

Berkeley eProtocol for Human Subjects Research Goes Live!

2009-03-20T14:46:00.000-07:00

Berkeley eProtocol is a user-friendly, online system for submitting, tracking, reviewing, and approving OPHS/CPHS human research protocols. Berkeley eProtocol will replace the current paper-based process, starting with exempt and expanding to expedited and full Committee applications as it is rolled out over the coming months.

Exempt Protocol Pilot of eProtocol

Currently, eProtocol is available for the submission of exempt protocols only. The purpose of the eProtocol exempt protocol pilot is to ensure that the system is running smoothly before opening it up to all submissions. Exempt applications submitted via Berkeley eProtocol will be given priority in the OPHS review process.

If you are submitting an exempt protocol and want to participate in this Berkeley eProtocol pilot, go to: http://cphs.berkeley.edu/content/eprotocolpilot.htm.

What is Exempt Research?

For information about what it means to qualify as exempt, categories, and examples of exempt research, see the CPHS Guidelines in Exempt Research at: http://cphs.berkeley.edu/content/exempt.htm.

Question and Comments

If you have any questions or comments about the new Berkeley eProtocol system, please contact OPHS Director Rebecca Armstrong at rda@berkeley.edu or OPHS eProtocol project manager Maria Savage at mcsavage@berkeley.edu.

Workshop for Graduate Students on Human Subjects Research

2009-01-26T11:16:00.000-08:00

Rebecca Armstrong, the Director of the Berkeley campus Office for the Protection of Human Subjects is presenting a two-part workshop series for graduate students on February 24 and March 4, 2009.

There is no preregistration for either workshop. Although graduate students are encouraged to attend both parts of the series, attendance at both is not required.

Human Subjects Research: What is it? How do you navigate through the IRB process?

WORKSHOP I: FUNDAMENTALS OF HUMAN SUBJECTS RESEARCH
Thursday, February 24, 2009 - 10:00 a.m. until noon - 370 Dwinelle Hall

This workshop will cover the following topics:

What is human subjects research?
What are the regulations governing human subjects research?
Is what I’m doing research that involves human subjects?
What does it mean when your research is exempt, expedited, or full board?
What is CPHS and who is OPHS and how do they interrelate?
How do CPHS and OPHS relate to the Sponsored Projects Office (SPO)?
What is the Collaborative IRB Training Initiative (CITI) Course in the Protection of Human Subjects and am I required to take it?

WORKSHOP II: NAVIGATING THE INSTITUTIONAL REVIEW BOARD (IRB) PROCESS
Wednesday, March 4, 2009 - 1:00 to 3:00 p.m. - 370 Dwinelle Hall

This workshop will cover the nuts and bolts of submitting a research protocol to the Office for the Protection of Human Subjects, and it will focus on the following two topics:

Completing the Forms and Writing the Narratives

How do you get a protocol through the approval process?
When do you submit amendments to protocols?
How do you write a good narrative?

Informed Consent and the Informed Consent Process

What is informed consent?
How do you write an informed consent form? What should you include?

RAC Offices to Close During the Annual Campus Winter Break

2008-10-29T15:02:00.000-07:00

The Office for the Protection of Human Subjects, the Sponsored Projects Office, and the Research Administration and Compliance Office will be closed during the campus energy curtailment beginning Thursday, December 25, 2008 through Friday, January 2, 2009. The Animal Care and Use Committee Office will be closed beginning Wednesday, December 24, 2008 through Friday, January 2, 2009. Offices will reopen on Monday, January 5, 2009.

SPO Proposal Submission

Proposals with deadlines during the campus shutdown should arrive at SPO by Friday, December 12, 2008.
Proposals due at agencies in early January should be at SPO by Monday, December 15, 2008.
No deliveries will be accepted after noon on December 24, 2008; any documents left in the drop box over the break will not be retrieved and logged until January 5, 2009.

ACUC Protocol Submission

The deadline for protocol submission for the January 21, 2009 meeting is Monday, December 8, 2008.
The deadline for protocol submission for the February 18, 2009 meeting is January 12, 2009.
ACUC will be closed on December 24, 2008.

CPHS Protocol Submission

The deadline for protocol submission for the December 5, 2008 CPHS-I meeting is Monday, November 10, 2008.
The deadline for protocol submission for the December 19, 2008 CPHS-II meeting is Monday, November 24, 2008.
There is no CPHS-I meeting in January 2009; the deadline for protocol submission for the February 6, 2009 CPHS-I meeting is Monday, January 12, 2009.
The deadline for protocol submission for the January 16, 2009 CPHS-II meeting is Monday, December 22, 2008.
Important: if your study was given full board review last January and approval will expire before January 16, 2009, you must submit your renewal application in time for review at a December 2008 CPHS meeting.
No deliveries will be accepted after noon on December 24, 2008; any documents left in the drop box over the break will not be retrieved and logged until January 5, 2009.

New Guidelines on Activities that Require CPHS/OPHS Review

2008-10-01T16:12:00.000-07:00

The campus Committee for Protection of Human Subjects and Office for the Protection of Human Subjects have developed new CPHS Guidelines on Activities that Require CPHS/OPHS Review in response to investigator requests for additional guidance about when to submit an application for CPHS/OPHS review.

Please consult with OPHS if you have any questions in this regard. CPHS welcomes any comments from the research community about this new guidance.

Save the Date: National Forum on Human Subject Research in Sacramento on February 8

2007-11-14T09:37:00.000-08:00

Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008
Co-sponsored by University of California Davis and OHRP
Doubletree Hotel, Sacramento, CA
Friday, February 8, 2008
http://www.research.ucdavis.edu/ohrpconference

The Office for Human Research Protections (OHRP) in conjunction with the University of California Davis will be sponsoring a National Research Community Forum entitled, “Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008,” on Friday, February 8, 2008, at the Doubletree Hotel in Sacramento California. Co-sponsors for this forum are the Northern California IRB Consortium Forum, the California State University Chancellor's Office, California State University Long Beach, the San Jose State University, and the California State University San Marcos.

This forum will focus on specific applications and interpretations of the regulations entitled, “Protecting Human Subjects” for conducting biomedical and behavioral research that is funded by the Department of Health and Human Services. The program will showcase experts from academia and the federal and state governments who will address unique aspects for balancing the principles of The Belmont Report in conjunction with federal and state laws and ensuring that the protection of human subjects in clinical trials is maximized. Representatives from the OHRP, U.S. Food and Drug Administration, National Institutes of Health, Department of Education, and the Department of Defense will provide federal regulatory updates and clarification of key policy issues.

This forum should be of special interest to those persons currently serving or about to begin serving as a member of an IRB as well as institutional officials and administrators, principal investigators, legal counsel, research staff, patient advocates, research sponsors, public health officials, privacy officials, compliance officers, laypersons and sponsors and contract research professionals.

Visit the UCD web site at http://www.research.ucdavis.edu/ohrpconference or contact Connie Koog at connie.koog@ucdmc.ucdavis.edu.

Berkeley Coeus Upgrade Coming Soon

2007-11-13T15:08:00.000-08:00

The Research Administration and Compliance Information Systems team (RAC-IS) is making final preparations to switch to the new, upgraded Berkeley Coeus version 4 in late November. The Berkeley Coeus system is the institutional system of record for tracking all Berkeley campus research proposals and awards processed by the Sponsored Projects Office (SPO) and the Industry Alliances Office (IAO). Data captured in Coeus is passed automatically to the Berkeley Financial System (BFS) to establish and modify fund accounts for project spending.

RAC-IS is working to make the transition to Coeus 4 as transparent and smooth as possible for the campus. However, during the move to the new system, Coeus may be unavailable for one to two days. The interruption in service will affect the Coeus to BFS feed for award set up as well as access to Coeus Web. Campus staff and faculty with possible issues related to award setup during this period may contact Kevin Phung (kphung@berkeley.edu). RAC-IS will provide more details on the move to Coeus 4 during the next several weeks.

The upgrade is a complete technical migration. The client application is now written in Java; upgrades from MIT will be incorporated as they are released, while at the same time preserving Berkeley customizations; the entire system will run on Campus Data Center Web Farm and database infrastructure; and all legacy data will be migrated to the new system. Benefits out of the box include enhanced capabilities for documenting proposal reviews, tracking agreement negotiations, managing subcontracts and subcontractors, and compliance information, among others.

The upgrade project lays the groundwork for future enhancements in a number of areas, including reporting and campus access to SPO data, conflict of interest disclosure tracking, routing and approval of proposals through the campus, and system-to-system submission of fully electronic proposals to the federal Grants.gov system. When implemented, the new human and animal subjects protocol systems will be integrated with Coeus.

RAC Offices to Close During the Annual Campus Winter Break

2007-10-25T16:10:00.000-07:00

The Office for the Protection of Human Subjects, Animal Care and Use Committee Office, and the Sponsored Projects Office, along with the Research Administration and Compliance Office, will be closed during the campus energy curtailment beginning Monday, December 24, 2007, through Tuesday, January 1, 2008. The RAC offices will also be closed for the afternoon on Thursday, December 13, 2007.

SPO Proposal Submission

Proposals with deadlines during the campus shutdown should arrive at SPO by Friday, December 7, 2007.
Proposals due at agencies in early January should be at SPO before Friday, December 14, 2007.

ACUC Protocol Submission

The deadline for protocol submission for the December 5, 2007 meeting is Monday, October 22, 2007.
The deadline for protocol submission for the January 23, 2008 meeting is Monday, December 10, 2007.

CPHS Protocol Submission

The deadline for protocol submission for the December 7, 2007 CPHS-I meeting is Monday, November 5, 2007.
The deadline for protocol submission for the December 14, 2007 CPHS-II meeting is Monday, November 12, 2007.
The deadline for protocol submission for the January 4, 2008 CPHS-I meeting is Monday, December 3, 2007.
The deadline for protocol submission for the January 18, 2008 CPHS-II meeting is Monday, December 10, 2007.
Please note that if your study was given full board review last January and approval will expire before January 4, 2008, you must submit your renewal application in time for review at a December 2007 CPHS meeting.

NIH Publishes September Extramural Nexus Newsletter

2007-10-01T09:47:00.001-07:00

The National Institutes of Health has published the September edition of NIH Extramual Nexus. The articles, linked below, include interviews, news, and updates from the agency.

For those planning on applying for NIH grants in the near future, a Use of Adobe Forms article explains that NIH will continue to use PureEdge forms at least through March 2008 grant application submission deadlines. A related article, Future Electronic Submission Transitions Still on Hold, states that the transition of NIH Training Grants (T), Career Development Awards (K), and Fellowships (F) to electronic application submission will not occur until Grants.gov can develop the new Adobe forms.

September NIH Extramual Nexus contents:

Work Begins on New Online Protocol Management System

2007-08-06T16:00:00.000-07:00

The Research Administration and Compliance Office is very pleased to report that work has begun on the “eProtocol” Project to implement an online protocol management system to support research projects involving human or animal subjects. The system is designed to replace manual, paper-based research protocol processes with a broadly distributed electronic system to simplify protocol submission, processing, and compliance monitoring. The Office of the CIO’s Technology Program Office is providing the services of Jon Conhaim who is representing RAC as project manager of the eProtocol Project.

Over the next months, we will be installing, configuring, testing, and performing a fit/gap analysis on the system. As part of this work, we will be interviewing faculty and OPHS, ACUC, and SPO staff to determine precisely how the system fits with our existing processes and what gaps may exist that will require process or system modifications.

We are excited to initiate this important project with outcomes that will benefit the entire campus.

RAC Forum: Save the Dates!

2007-08-02T17:47:00.001-07:00

The Research Administration and Compliance Office has scheduled the monthly RAC Forum meetings for the coming year. This year, we will be holding the RAC Forum on Wednesdays from 10:30 a.m. until noon. All meetings except for April will be held in the Tilden Room, 5th floor, ASUC Martin Luther King Jr. Student Union building. Please save the following dates:

September 12, 2007, 10:30-noon
October 10, 2007, 10:30-noon
November 14, 2007, 10:30-noon
December 12, 2007, 10:30-noon
January 16, 2008, 10:30-noon
February 13, 2008, 10:30-noon
March 12, 2008, 10:30-noon
April 16, 2008, 10:30-noon (location to be determined)
May 14, 2008, 10:30-noon
June 11, 2008, 10:30-noon

We will be sending the agenda for the September meeting soon. You can also check the RAC web site at http://rac.berkeley.edu/racforum.html.

As always, please feel free to contact us if you have ideas or suggestions for topics you'd like to see addressed at the meetings. We'll see you in September!

New Policies and Procedures of the UC Berkeley Human Research Protection Program

2007-07-24T14:34:00.000-07:00

A major revision of the Policies and Procedures of the UC Berkeley Human Research Protection Program (HRPP) has been approved by the Committee for Protection of Human Subjects (CPHS), and published on the CPHS web site. The new Policies and Procedures (P&P), effective July 1, 2007, replace the CPHS Policies and Procedures of November 2000 and related guidance (e.g., “Guidelines of the UC Berkeley CPHS” and “CPHS Appeal Process”).

The CPHS follows the P&P in approving, recommending modifications, and in extremely rare cases, suspending or terminating research involving human subjects. UC Berkeley operates within the regulations and guidelines set forth by federal authorities, primarily the Office for Human Research Protections and the Food and Drug Administration, and other bodies such as the International Conference of Harmonisation, all based upon ethical principles elucidated in the Belmont Report. Many of the policies and procedures are derived from these regulations.

The P&P Table of Contents has embedded links to the document sections, making navigation easier. CPHS will post Attachments and Grant-Protocol Review sections soon.

Human Subjects Updates

2007-04-15T18:44:00.000-07:00

New Forms
The Committee for Protection of Human Subjects posted revised forms on March 5, 2007, and is now requiring use of these new forms. Forms are available on the CPHS web site at http://cphs.berkeley.edu/content/forms.htm. Please delete all old versions that you may have downloaded to your local PC.

SPO Proposal Number
The Office for the Protection of Human Subjects must have the SPO Proposal Number on the CPHS Cover Sheet for all funding supporting human subjects research when the funding requests have been submitted through the Sponsored Projects Office. Please make sure you list the SPO Proposal Number in the appropriate box under Part III of the Application Cover Sheet if the funding is pending or even if an award has been made.

The SPO Proposal Number is an eight-digit number beginning with the fiscal year (e.g., 20071234) and is available for Coeus web users immediately after proposals are logged in by SPO. The number is included in the proposal notice that is sent by email to investigators and administrative staff after the proposal has been submitted.

For access to Coeus web site reports, please check with your departmental administrator. For more information about Coeus department accounts, please contact Neil Maxwell or Nancy Han in RAC Information Systems.

Revised Requirements for Continuing Review Submissions
To ease the administrative burden on investigators, CPHS/OPHS has changed the submission requirements for applications for Expedited or Full Committee Continuing Review and Approval. Effective immediately, submission of copies of the current, approved protocol narrative will not be necessary under the following specific conditions:

(1) At the time of renewal submission, NO CHANGES are being proposed to the protocol, including personnel or funding changes. The research that will be conducted in the coming year is exactly as described in the current, active approved protocol on file with CPHS/OPHS; and

(2) The current, approved protocol – which includes any amendments that may have been approved and incorporated in the narrative during the past year – must be written in the CPHS narrative format of September 2005 or the most recent version revised in March 2007.

Also, for studies that are moving into a “data analysis-only” phase, investigators will no longer need to submit consent forms, recruitment materials, or a protocol narrative at the time of continuing review, as long as the only change to the approved protocol is that there is no longer any data collection or subject intervention occurring. If the protocol format has not been updated since September 2005, but the study is moving into a data analysis-only phase now, an updated protocol version will not be required. However, if an investigator wishes to collect additional data and/or recruit new subjects, the protocol narrative in the current version as required at that time must be submitted before the protocol amendment will be reviewed and approved.

Submit Protocols Early
CPHS/OPHS is in the midst of the busiest time of the year as investigators want to get protocols reviewed and approved in time for summer research activities. OPHS strongly advises investigators to submit their projects as soon as possible as all but the full committee protocols are reviewed on a rolling, first-come, first-served basis. Between March and June we are essentially unable to handle “rush” requests due to the huge volume of protocols, so get your protocols in as soon as possible!

Human Stem Cell Research Policy for Campus

2007-03-15T07:57:00.001-07:00

In order to ensure that all UC Berkeley research involving the use or derivation of human stem cells is conducted with the highest ethical and scientific standards, and in compliance with all applicable government regulations, UC policies, and the requirements of extramural sponsors, the Vice Chancellor for Research has announced a new campus policy for the review and approval of human stem cell research.

The policy states that before beginning research using human stem cells or deriving human stem cell lines, Berkeley investigators must have their research protocol approved by the newly formed campus Stem Cell Research Oversight Committee (SCRO).

The announcement to campus is available at https://mossberg.berkeley.edu/CALmessages/display_message.asp?d=2/15/2007&s=100. The policy is published at http://research.chance.berkeley.edu/page.cfm?id=203 or http://campuspol.chance.berkeley.edu/policies/stemcells.pdf.