Source: https://oshpd.ca.gov/data-and-reports/data-resources/cphs/
Timestamp: 2019-05-25 03:40:17
Document Index: 617102664

Matched Legal Cases: ['art 46', 'arts 50', 'art 160', 'art 46', 'art 46', 'art 50', 'art 56', 'art 160']

Submit research projects for review to IRBManager
Forms, Bulletins, and Resources
Forms, bulletins, and FAQs for research project submissions
Find forms	See FAQs
Find meetings, meeting dates, and project submission deadlines
See upcoming meeting	Find all meeting dates
Learn more about CPHS membership
See committee members	Join the Committee
Learn more about the laws, regulations, and policies of CPHS
See laws and regulations	See policies
Learn more about CPHS and our mission
IRB Manager#
Log in to IRBManager
CPHS has migrated to an online submission system, IRB Manager, and is accepting submission for all new and continuing projects.
Log-In to IRBManager
CPHS IRBManager Manual for Researchers
Forms and Bulletins#
These forms may be printed and filled in by hand and submitted with original signatures or the Word documents may be filled in electronically, printed and submitted with original signatures.
Checklist For Research Involving Children
Checklist For Research Involving Neonates
Checklist for Research Involving Pregnant Women and Fetuses
Checklist for Research Involving Prisoners
Order Form for California’s Confidential Vital Statistics Death Data Files
Departmental Review Letter for CA Information Practices Act
Authorization Agreement with Another Institutional Review Board
Authorization Agreement for Organization without an IRB Relying on CPHS
Informed Consent Definitions
Participant’s Bill of Rights for Medical Research (English & Spanish)
Participant’s Billl of Rights for Non-Medical Research (English & Spanish)
Data Security Requirement Letter (Sample)
IMPORTANT – ADVERSE EVENT/UNANTICIPATED PROBLEMS REPORTING REQUIREMENTS:
Adverse Events, Unanticipated Problems, Data Security Breaches, and Protocol Deviations are submitted via a Report Form on IRBmanager. Report Forms can only be accessed on IRBManager. For additional information, please view our FAQs section on how to submit an Adverse Event/Unanticipated Problems Form or call the CPHS main line at (916) 326-3661 for assistance.
Meetings and Deadlines#
Meeting and Protocol Submission Deadline Schedule 2018
Meeting Date | Protocol Submission Due Date
February 2, 2018 | January 5, 2018 – Agenda
April 6, 2018 | March 2, 2018 – Agenda
June 1, 2018 | May 4, 2018 – Agenda
August 3, 2018 | July 6, 2018 – Agenda
October 5, 2018 | September 7, 2018 – Agenda
December 7, 2018 | November 2, 2018 – Agenda
Meeting and Protocol Submission Deadline Schedule 2019#
February 1, 2019 | January 4, 2019 – Agenda
April 5, 2019 | March 1, 2019
June 7, 2019 | May 3, 2019
August 2, 2019 | July 5, 2019
October 4, 2019 | September 6, 2019
December 6, 2019 | November 1, 2019
Committee Members#
Juan Ruiz, M.D., Dr.PH., M.P.H. (Chair) – Chief, Communicable Disease Emergency Response Program – Division of Communicable Disease Control – California Department of Public Health
Alicia Bazzano, M.D., Ph.D., M.P.H. – Chief Physician Consultant
Westside Regional Center – Clinical Faculty, Pediatric Emergency Medicine – University of California, Los Angeles
Darci Delgado, Psy.D., M.S. – Psychologist, Analytics and Research Team
Larry L. Dickey, M.D., M.P.H., M.S.W. – Medical Director
Office of Health Information Technology – California Department of Health Care Services
Maria Cesaltina da Silveira Nunes Dinis, Ph.D., M.S.W. – Professor and Director of M.S.W. Admissions
Division of Social Work – California State University, Sacramento
Lois Lowe, Ph.D. (Retired)
California Department of Corrections – California Department of Alcohol and Drug Programs
Laura Lund, M.A. Research Scientist
Center for Health Statistics and Informatics – California Department of Public Health
Fred Molitor, Ph.D. Adjunct Faculty
Philip T. Palacio, Ed.D, M.S.M.
California Correctional Health Care Services – Medical Contracts Unit – California Department of Corrections and Rehabilitation
John Schaeuble, Ph.D. Professor of Psychology Emeritus
Alternate Member – Millard Murphy, J.D., Retired from the University of California, Davis
Now Recruiting: Join the Committee!#
CPHS is currently recruiting three members.
The guidelines are established by federal requirements and include diversity factors such as race, gender, and cultural background.
CPHS shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. CPHS shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, CPHS shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. CPHS shall, therefore, include persons knowledgeable in these areas. CPHS regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons. Individuals who are knowledgeable about and experienced in working with these subjects are encouraged to apply.
CPHS IRB members consist of the following:
• Scientist member( s) whose training, background, and occupation would allow them to view scientific activities from the standpoint of someone within a behavior or biomedical research discipline and;
• Non-scientist member( s) whose training, background and occupation would view research activities from a standpoint outside of any biomedical or behavioral scientific discipline.
Review Process and Training
CPHS receives all protocols through the on-line system, IRBManager. CPHS uses a reviewer system in which members are assigned to review and approve studies. These studies can be extremely varied in subject matter ranging from studies of autism or infectious diseases to pilot programs addressing domestic violence or infant health. Members are not permitted to review projects in which they personally or their immediate supervisors are involved. Projects involving direct contact with human subjects that involve state funding, or staff or human subjects affiliated with any departments under the CHHS are reviewed at convened meetings of the CPHS that occurs every two months.
New members are assigned a mentor who has been serving on the committee for several years. CPHS staff also available for any questions that may arise. CPHS members often work with researchers to resolve any deficiencies in the protocols submitted to the CPHS for review and approval. Training and materials will be provided to the on-line system, IRBManager.
Members review 15–25 research projects varied in subject matter, ranging from studies of autism or infectious diseases to pilot programs addressing domestic violence or infant health during each two-month renewal/new project cycle. All projects are reviewed and approved via the online system, IRBManager. Meetings are every two months on the first Friday, in February, April, June, August, October, and December. All meetings are held in Sacramento, California.
Members may also serve on subcommittees as needed.
Members who currently are State workers receive 10% release time to serve on CPHS. Members shall receive travel reimbursement in accordance with California Human Resources Laws and Rules.
To apply, please submit the a cover letter addressing your education and experience and submit to:
CPHS Administrator
2020 West El Camino , Suite 1100
The application must be received in the CPHS Office by May 15, 2019.
If you any questions, contact Lucila Martinez at (916) 326-3661.
Laws and Regulations#
Federalwide Assurance For The Protection of Human Subjects#
The Federalwide Assurance is the formal agreement between the California Health and Human Services Agency (CHHSA) and the United States Department of Health and Human Services (DHHS) stipulating that all research conducted within the jurisdiction of the CHHSA will be reviewed by the Committee for the Protection of Human Subjects in accordance with the ethics and procedures designated in the Common Rule.
The CPHS operates under the terms of Federalwide Assurance (FWA) 00000681 (pdf) signed in October 2011 with the U.S. Department of Health and Human Services, and conducts business, as appropriate, in compliance with the:
The Common Rule (45 CFR Part 46 of the Code of Federal Regulations), regulates ethics for research projects involving human subjects that are funded by the United States Department of Health and Human Services and many other federal departments. It also provides specific requirements for the form and function of institutional review boards (IRBs). The Committee for the Protection of Human Subjects operates in compliance with the Common Rule in reviewing human subjects research regardless of the funding source and promotes the high ethical principles contained in the Common Rule.
The Federal Food and Drug Administration (FDA) regulates clinical investigations involving food, drugs, medical devices, and biological products for human use. As a federally-chartered institutional review board, the Committee for the Protection of Human Subjects reviews such research in accordance with FDA regulations 21 CFR Parts 50 and 56.
The Privacy Rule of the Health Insurance Portability and Accountability Act (45 CFR Part 160)protects personal health information by designating that it may not be released for research purposes unless the patient has signed an authorization or an institutional review board (or privacy board) has approved a waiver of a signed patient authorization. The Committee for the Protection of Human Subjects (CPHS) reviews requests for waivers of patient authorization in accordance with the HIPAA Privacy Rule.
California Information Practices Act, Civil Code, Section 1798.24 (SB13), requires CPHS review and approval before personal information (linkable to any individual) that is held by any state agency or department can be released for research purposes.
Protection of Human Subjects in Medical Experimentation Act
Sections 24170-24179.5 delineate State law regarding the rights of human subjects participating in medical experiments. This includes: the “Experimental Subject’s Bill of Rights,” required elements of informed consent, and consent by surrogate decision makers.
Sections 102425-102475 delineate state law regarding the collection and release of information on birth certificates, including the responsibilities of the State Registrar and the Committee for the Protection of Human Subjects.
Section 102231(a)(3) states that “Death data files for public release shall not contain the mother’s maiden name and social security number.” Section 102231(a)(5) states, “Death data files containing personal identifying information may be released to persons expressing a valid scientific interest, as determined by the appropriate committee constituted for the protection of human subjects that is approved by the United States Department of Health and Human Services an has a general assurance pursuant to Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.” The full text of these and related statutes are contained in Sections 102175-102249.
Section 3500 provides definitions of biomedical and behavioral research.
Sections 3501-3509.5 delineate general provisions and prohibitions for conducting research with prisoners.
Sections 3515-3520 delineate administrative requirements with regard to research with prisoners.
Sections 3521-3523 delineate prisoners’ rights when participating in research, including informed consent.
Section 3524 addresses prisoners’ legal remedies for injuries incurred while participating in research.
Policies and Procedures#
The California Health and Human Services Agency (CHHSA) established the Committee for the Protection of Human Subjects (CPHS), an institutional review board, in July 1976. The Health and Human Services Agency is bound by the terms of the Federalwide Assurance (FWA) 00000681 signed in June 2001 with the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections. The CPHS is the only Institutional Review Board (IRB) empowered by the California Health and Human Services Agency.
Policies & Procedures (22 pages)
Legal Authority and Scope#
The CPHS operates under the terms of Federalwide Assurance (FWA) 00000681 signed in June 2001 with the U.S. Department of Health and Human Services, and conducts business, as appropriate, in compliance with the:
Common Rule (45 CFR Part 46 of the Code of Federal Regulations)
Food and Drug Administration regulations (21 CFR, Part 50; 21 CFR, Part 56)
Privacy Rule of the Health Insurance Portability and Accountability Act, (45 CFR, Part 160)
California Information Practices Act, Civil Code, Section 1798.24 (SB13)
Scope of Authority#
In compliance with the Federalwide Assurance, the CPHS is obligated to review all research involving human subjects, regardless of funding source, meeting any of the following criteria:
Research sponsored by the California Health and Human Services Agency (CHHSA) or any of its departments.
Research conducted by or under the direction of any employee or agent of the CHHSA or any of its departments.
Research using personally identifiable data held by the CHHSA or any of its departments.
Research involving subjects for whom the CHHSA or any of its departments have direct responsibility, such as patients in State hospitals.
The California Information Practices Act (SB13) (effective January 1, 2006) requires CPHS review and approval before personal information (linkable to any individual) that is held by any state agency or department can be released for research purposes.
Reciprocity with Other Institutional Review Boards#
The CPHS will engage in formal agreements to serve as the institution review board for other institutions in California with current Federalwide Assurances in place. Reciprocity arrangements to enable other institutional review boards to approve projects for the CPHS under the Federal Common rule will be considered on a case-by-case basis. The CPHS does not delegate reviews for compliance with the California Information Practices Act, Civil Code, Section 1798.24 (SB13) to other institutional review boards.
Mission and Purpose#
Ethical Principles#
Respect for Persons#
Beneficence#
“Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.”
“The selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.”
CPHS Purview#
CPHS is the institutional review board (IRB) for all of the departments under the California Health and Human Services Agency (CHHSA). See Instructions, page 8 for a list of departments under CHHSA. CPHS is also the IRB required to review all research-related requests for state personal information to the University of California and non-profit educational institutions. CPHS must also approve research requests for Death Data from the California Department of Public Health.
CPHS Protocol Submissions#
CPHS has transitioned to a new electronic protocol submission and approval system, IRBManager. View the IRBManager Manual for Researchers for technical information and screen shots about registering for and utilizing this system.
CPHS Review Process#
Depending on the type of research being executed, review may be conducted at a convened meeting of CPHS or completed on an expedited basis. Expedited reviews may have one to three reviewers. Most projects that have any contact with human subjects, such as a survey or collection of specimens, must be initially approved at a convened meeting. If they are deemed to be minimal risk, all subsequent reviews may be done on an expedited basis. All data-only projects are approved on an expedited basis.
CPHS Meetings#
CPHS meetings are held on the first Friday of even-numbered months (February, April, June, August, October, and December) from 8:30 AM to 5:00 PM. Meetings are held in Sacramento at 2020 West El Camino Avenue, Sacramento, CA. The schedule and location of upcoming meetings and the agendas for those meetings are available on OSHPD’s Public Meeting page. Researchers are encouraged to appear in person, but may attend by telephone if arrangements are made in advance with the CPHS Administrator. All meetings are open to the public and conducted in compliance with the Bagley-Keene Open Meeting Act.
CPHS Members#
The 13 CPHS members are volunteers who are appointed by the Secretary of the California Health and Human Services Agency (CHHSA). Members are chosen for their expertise in differing fields of research and abilities to represent and understand the needs of diverse research subjects, particularly those who may be vulnerable due to factors such as age, socio-economic status, ethnicity, or medical conditions. Detailed information about current CPHS members is available in the CPHS Members section.
CPHS Administrator#
Lucila Martinez, Administrator
Phone: (916) 326-3661
CPHS Assistant Administrator#
Adrienne Starkey, Assistant Administrator
CPHS Chair#
Juan Ruiz, MD, DrPH, MPH
What is CPHS and what do we do?
CPHS (Committee for the Protection of Human Subjects) is the Institutional Review Board (IRB) for all of the departments under the California Health and Human Services Agency. As such, the IRB is required to review all research-related requests for state personal identifiable information from the University of California and non-profit educational institutions.
What is defined as research?
According to CFR 46.102, research is defined as a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Therefore, this project will require CPHS’ review.
If a project falls under any of these parameters, it will require CPHS’ review and approval.
What is defined as non-research?
An exemption for non-research can be approved based on the following:
Public health practice/surveillance
Resource utilization review
What is defined as Exempt Research?
An Exemption for Research can be approved based on the following:
Research involving analysis/study of existing data
Research involving data which is publicly available
No identifiable data is being requested from any of the CHHSA departments
Top 3 Questions#
1. I have submitted my IRBManager application. What is the next step?
CPHS staff screens all protocols before assigning it to a Reviewer(s). If the protocol is incomplete or missing documents, CPHS staff returns the protocol to the Primary Investigator (PI) using the “Notes” feature. Once the protocol is received with the correction, staff will re-screen and assign to a Reviewer(s). If the Reviewer(s) needs any clarifications on the information provided, the Reviewer uses the “Notes” feature to communicate with the Primary Investigator (PI). Once the Primary Investigator (PI) receives the note in IRBManager, the Researcher is able to edit the protocol.
Quick Tips to Pass Screening:
♦ Projects cannot begin before they have been reviewed. List your project’s anticipated start date as the day of or after the next public meeting at which it will be heard.
♦ The Responsible Official (RO) is one to two levels above the PI (i.e., your boss or your boss’ boss). Common ROs include:
—department chair
—chief deputy director or director
—a PhD candidate may list his or her advisor
♦ Be sure to click the “Submit” button when the project application form is ready for the next level of review. If you do not click the Submit button—even if you have completed and electronically signed the form—the application stays in your queue, and CPHS will not screen it. The PI and RO must also click the Submit button.
2. How do I receive the data once my protocol has been approved?
The Researcher provides a copy of CPHS’ approval letter and submits it to the department that holds the data. CPHS is not responsible for notifying individual departments.
3. When will I be notified that my Adverse Event Review has been approved?
The Committee Chair, Vice Chair and the Reviewer review each Adverse Event Report as soon as it is received. Once it has been reviewed and recommended for approval, the Report is scheduled onto the next Committee’s public meeting date. At the meeting, the Reviewer provides a brief summary of the event report and the corrective steps taken by the Primary Investigator (PI). The Committee votes to approve or disapprove the report. Upon the Committee’s decision of the report, CPHS staff releases the appropriate letter via IRBManager within ten business days after the meeting.
Types of Reviews#
Expedited Review protocols are reviewed on an expedited basis by one or two Reviewers, as opposed to the entire committee at the next scheduled CPHS public meeting.
What is a Full Committee Review?
Projects that have any contact with human subjects, such as a survey or specimen collection, must initially be presented and approved at the next scheduled CPHS public meeting.
Also, if a Reviewer determines a project must be reviewed by additional members beyond the two assigned Reviewers, the project is scheduled for the next CPHS public meeting.
What is an Exempt Review?
Exempt Review protocols are reviewed on an expedited basis by one or two Reviewers to determine if protocol falls under CPHS purview.
IRBManager Accounts/Personnel#
How do I add staff to my protocol on IRBManager?
Initiate an Amendment to the protocol and attach the PIs and Co-PIs curriculum vitae.
Once your account is created, you will be required to contact CPHS staff for any changes except for your password. If the need arises, to change/reset passwords, go to the “IRBManager page” and click on the “Forgot Password” option at the lower right of the screen.
For other account information changes, (i.e., address, phone, organization) contact CPHS staff.
How can I update personnel changes for my project on IRBManager?
If the personnel or email address associated with your project have changed, an amendment must be initiated and submitted to CPHS via IRBManager. These types of changes will be reviewed on an Expedited basis. For these types of revisions, an Expedited basis is reviewed within ten business days after submission.
What is the time line for projects to be reviewed?
If projects are submitted by the submission deadline, they are approved on that cycles’ meeting date. (Note: All projects are reviewed for quality and completeness of the application).
Special considerations: Determination requests and amendments can be approved at any time. New Expedited projects can be approved within five to ten business days after the CPHS public meeting. Projects presented to the CPHS Committee receive approval or deferred approval letters within five to ten business days after the CPHS public meeting. Deferred projects will not receive an approval letter until all revisions are approved by a subcommittee. The subcommittee also determines if the project requires to be re-evaluated by all the members.
I have submitted my IRBManager application. What is the next step?
CPHS staff screens all protocols before it is assigned to a Reviewer(s). If the protocol is incomplete or it has missing documents, CPHS staff returns the protocol to the Primary Investigator (PI) using the “Notes” feature in IRBManager. The Primary Investigator (PI) addresses the concerns and returns the protocol using the “Notes” feature. Once the protocol has successfully passed screening, it is assigned to a Reviewer(s). Should the Reviewer require any clarifications, he/she will send a note via IRBManager to the Primary Investigator (PI). The Primary Investigator (PI) and all personnel listed on the protocol receive a system generated email message. Once this message is received, the protocol can be edited. Once the revisions are completed, the Primary Investigator (PI) returns a note on IRBManager and returns the protocol to CPHS by clicking “Save” and “Done”. If the application meets all the requirements, the Reviewer recommends approval. All approval letters are released after the CPHS public meeting dates. For meeting dates and submittal dates, visit the CPHS homepage
What is the renewal window period for Continuing Renewals?
Continuing Renewal reviews can be started and submitted for protocols 60 days prior to the project’s Primary Investigator (PI) expiration date. Once the protocol’s expiration date is reached, Researchers can no longer start or submit Continuing Renewal reviews.
What is a submission deadline?
Submission deadlines are set one month prior to the CPHS public meeting date. During this time period, CPHS staff screens and processes and assigns all protocols to the Reviewers before the public meeting date.
Expiration dates are set a year from the project’s current approval date. Most projects are approved for one year.
When should the Data Security letter be submitted?
All data security questions must be answered on Cal Protects. If a question does not apply to your protocol, indicate your response as “N/A.” Do not leave any questions blank.
The Data Security Letter must be signed by your organization/department’s Chief Information Officer, Privacy Officer, Security Officer or an equivalent position. This letter is required to be attached to your online protocol prior to its approval. If there is a delay in obtaining this document, you will need to contact CPHS staff for assistance.
How often do I have to update my Data Security letter?
The Data Security Letter must be updated whenever there is an amendment that led to the change of personnel. This includes Primary Investigator (PI) RO, Chief Information Officer, Privacy Officer, Security Officer, or an equivalent position.
Who can sign the Data Security Letter?
The Data Security Letter MUST be signed by your organization/departments Chief Information Officer, Privacy Officer, Security Officer or an equivalent position.
(Note: The Primary Investigator (PI) CANNOT sign the Data Security Letter. All letters that are not signed by the appropriate officer will not be valid.)
Who needs to register an account for IRBManager?
It is mandatory for the Principal Investigator (PI) and Responsible Official (RO) to register on IRBManager prior to creating a protocol. If the project has other contacts, such as the Co-Principal Investigator (Co-PI), Administrative Contact and Other Contact, each individual must also register on IRBManager. This allows them to access and receive emails on the protocol.
Reminder Emails/Notifications#
Only personnel registered with Cal Protects User accounts linked to a protocol receive emails regarding said protocol. If your account is listed in a protocol’s Personnel Information section, but you are not receiving any email notifications, check the Spam folder of your email address and/or check with your organization’s IT department to inquire if your firewall is blocking the email from being received. If you are still not receiving notifications, please contact CPHS Staff at (916) 326-3660 or by email to request access to the project.
Protocol Track Changes/Revisions#
I submitted the revised language within the protocol and I am unable to view the track changes/revisions?
Once you have submitted the revisions, a side by side comparison screen appears for CPHS staff and Reviewers for comparison and review. The system does not allow the Researcher to view this screen.
Do I need to attach documents with track changes?
Yes, if changes are being proposed for attached documents, include the track changes version and a clean copy version with the changes. DO NOT delete any original documents.
Top Three Questions#
Who is the Responsible Official?
The Responsible Official is an individual who is above the Principal Investigator in the line of authority.
How do I know if I need CPHS’ approval on my project?
If you are not certain whether or not the project requires CPHS’ review/approval, please select the “Determination of Not Research/Exempt Research” category.
How do I make changes to my project once it has been submitted to CPHS?
Once the project is submitted, you are only able to “view” the protocol. If the protocol was submitted in error or if additional information needs to be included, you will need to contact CPHS staff at (916) 326-3660 or by email to request access to the project.
Determination Requests#
What should I expect after submitting a Determination Request?
After you have submitted a Determination Request, CPHS staff screens for completeness and assigns the protocol to a CPHS Reviewer. If the CPHS Reviewer determines that the project is exempt, an approval for Exemption letter is released via IRBManager. An automatic system email notifying all personnel listed in the protocol is also released. However, if the project is determined to be Not Exempt the Determination Request is denied in IRBManager. (In addition, a detailed email stating the reason(s) and instructions on how to obtain CPHS approval is sent to the personnel listed in the protocol.)
What is the process to request a Determination of Non- Research/Exempt Research?
The registration process must be completed. Once you have registered, you will have access to complete a request for Determination of Non-Research/Exempt Research.
CPHS IRBManager Researcher Manual (PDF)
New Projects#
My project was determined to be presented at a CPHS Full Committee meeting, what are the next steps?
If a protocol requires Full Committee presentation, CPHS notifies the Researcher(s) that 14 hardcopies need to be mailed to CPHS, two to three weeks prior to the upcoming public meeting date. CPHS staff coordinates all the logistics with the Primary Investigator (PI), i.e., time, place, etc. The Primary Investigator (PI) is provided with an option to make a personal appearance or attend by teleconference on the day of the meeting.
How do I create a new project/protocol on IRBManager?
Once all the required individuals (at a minimum the Primary Investigator (PI) and the Responsible Official) have successfully registered, you are able to create a protocol.
In addition to providing the responses, the following documents must be uploaded under the “Attachments Section”:
Curriculum Vitae of the Principal Investigator, Co-Principal Investigator(s), and Translator (if applicable)
Complete the New Project Application and Review Checklist.
Cover letter summarizing the project
Attach the signed Data Security Letter/statement from your Internet/Data Security Officer. For additional information on the requirements of the Data Security Letter, please click here.
Any and all other project documents related to the project. You may also view a sample of the required letters.
Continuing Renewals#
How do I renew my project’s approval or file for a Continuing Renewal Review?
You are only able to renew the project within 60 days of the project’s expiration date.
I did not renew my project in time and now it is expired. What steps do I need to take to obtain approval?
Contact CPHS Staff. Expired projects are reviewed on a case by case basis.
Do I have to create a new protocol to renew my project?
No. New protocols are only created when a new project is submitted to CPHS for the first time. Existing projects that require renewals will appear on the Researcher Dashboard.
Can I make changes to my protocol while filing for a Continuing Renewal Review?
Yes. Changes are strongly encouraged to be included and must be provided in the Continuing Renewal section of the project.
What do I need to attach when filing for a Continuing Renewal Review?
All documents being added or altered to the project must be attached when Continuing Renewal Review is filed. Do not delete previously attached documents unless instructed by CPHS staff.
How can CPHS distinguish what has been changed within my protocol?
All tracked changes made to the protocol are automatically saved on the IRBManager system.
By what date do I need to submit my project for a Continuing Renewal Review?
A project’s deadline date for renewal is one month before the CPHS’ meeting date. The dates can be found on the CPHS homepage under CPHS Meetings.
Amendments#
How do I make changes to my approved protocol before it is due for renewal?
To make any changes on your protocol, an Amendment Review must be completed via IRBManager.
By what date do I need to submit my project for an Amendment Review?
Amendments can be submitted at any time and are not subject to Deadline Dates.
Completing and Withdrawing Projects#
I want to withdraw a project which has not been entered into IRBManager. What am I required to do?
Projects that are withdrawn from CPHS require the submission of the following documents:
A cover letter clearly summarizing the reasons for withdrawal of the project.
Include a description of the plan for the destruction or return of any data used in the study. If the data will be retained, include a justification.
Appropriate Project Forms: (Continuing Periodic Review Data Only or Human Subject Contact, Annual Report Form for Information Practices Act, or Death Data Only) found here. The box next to “Withdrawn” must be checked.
I completed a project which has not been entered into IRBManager. What am I required to do?
For completed projects, you are required to submit of the following documents:
A cover letter clearly summarizing any results and knowledge gained from the research project. Also include a description of the plan for the destruction or return of any data used in the study. If the data will be retained and include a justification.
Appropriate Project Forms: (Continuing Periodic Review Data Only or Human Subject Contact, Annual Report Form for Information Practices Act or Death Data Only) found here. The box next to “Completed” must be checked.
Copies of any reports or publications related to the research.
I received an email stating I have “Notes” on my project. What are Notes?
CPHS staff uses the “Notes” feature to communicate with the Primary Investigator (PI) or Co-Primary Investigator (Co- PI) to obtain clarification or obtain missing information/documents during the initial screening of the project. All documents and/or comments requested must be addressed before resubmitting to CPHS.
I received an email stating that the Reviewer has left a Note on my project. What are notes?
Once your project has successfully passed the screening process, the project is assigned to a Reviewer(s). The “Note” feature is used as the communication tool between the Reviewer and the Researcher. The Reviewer will initiate the “Note” feature to obtain clarifications on the projects.
(Note: Not all projects will receive Return Notes and/or Comments.)
Approval Letters#
When will I be notified that my Amendment Review has been approved?
Upon the Reviewer’s approval of your amendment, CPHS staff will release the approval via IRBManager. The email notification will contain the approval and instructions on how to obtain the project’s approval letter. The email is sent to all personnel listed on the project.
When will I be notified that my Continuing Renewal Review has been approved?
Researchers are notified of their Continuing Renewal Review approval on their project’s cycle meeting date.
Why do I have to wait until the CPHS meeting date to get my Approval Letter?
All projects are officially approved on IRBManager ten business days after the CPHS public meeting. This allows all projects
Adverse Event/Unanticipated Problems Forms#
What is an Adverse Event/Unanticipated Problems? How do I report it to CPHS?
An Adverse Event/Unanticipated Problems entails unanticipated problems (including breach of data security) or adverse events involving risks to human subjects while the research is being conducted. A “Report Form” must be completed and submitted via IRBManager within 48 hours of the event. To file a report, you must log into IRBManager. Additionally, you must call CPHS staff at (916)326-3660 to notify them of the report submission.
A breach of data security occurred on my project, is this reportable?
A breach of data security is considered an unanticipated problem during the research. A “Report Form” must be completed and submitted via IRBManager within 48 hours of the event. To file a report, you first log into IRBManager. Select report form andn it will open a separate screen. Once the form has been submitted, you must call CPHS staff at (916)326-3660 to notify them of the report submission.