Human Research Protection Program Training Lisa Voss, MPH, CIP Assistant Director, HRPP Quality Improvement Unit Lisa.Voss@ucsf.edu 415-514-2152 Preparing an Exempt or Expedited Application February 20, 2009

HRPP Training: Upcoming Sessions Introduction HRPP Training: Upcoming Sessions The Study Coordinator's Role in Investigator-originated Studies Date and Time: Tuesday, March 10, 2009, 10 a.m.-noon Location: Parnassus campus, N-225 Speaker: Diane Davies RN, Manager, Clinical Research Unit, Helen Diller Family Comprehensive Cancer Center Preparing Consent and Assent Forms Date and Time: Thursday, April 30, 2009, 10 a.m.-noon Location: Parnassus campus, N-225 Speaker: Richard Wagner, Associate Director

Outline for Today Demystifying the CHR review process Introduction Outline for Today Demystifying the CHR review process The Exempt Application The Expedited Application Top Tips for Speeding Up CHR Approval Getting Answers After this Class Open Questions and Answers

Demystifying the CHR Review Process

“Is the project human subject research?” Demystifying the CHR Review Process First Step: Determining “Is the project human subject research?”

Definition of Research Demystifying the CHR Review Process Definition of Research A systematic investigation, including Research development, testing and evaluation Designed to develop or contribute to generalizable knowledge 45 CFR 46.102

Definition of Human Subject Demystifying the CHR Review Process Definition of Human Subject A living individual about whom an investigator, whether professional or student, conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information DHHS 45 CFR 46.102

When is it NOT a Human Subject Demystifying the CHR Review Process When is it NOT a Human Subject If the Investigator obtains coded data or biological samples under the following conditions: The coded private information or specimens cannot be collected specifically for the current proposed research project, and one or more of the following apply: The key to decipher the code is destroyed before the researcher begins, or The PI and holder of the key enter into an agreement prohibiting the release of the key under any circumstance (The CHR recommends a written agreement be secured between the recipient and the provider of the specimens or data. The CHR will not require review of these agreements.), or There are IRB-approved written policies for the repository or data management that prohibit the release of the key.

Demystifying the CHR Review Process

Demystifying the CHR Review Process

Determining the Level of Review/Type of Application to Submit Demystifying the CHR Review Process Second step: Determining the Level of Review/Type of Application to Submit

Review Level Based on Risk to the Subject Demystifying the CHR Review Process Review Level Based on Risk to the Subject The level of risk to the subject determines the level of review required and therefore the type of application The risk level is compared to “minimal risk” as defined by federal regulations “Minimal risk” means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests 45 CFR 46.102

CHR Levels of Review/Applications Demystifying the CHR Review Process CHR Levels of Review/Applications Greater than minimal risk: Full Committee Less than minimal risk: Expedited Review (Category 1-4, 6, 7) Expedited Review: No Subject Contact (Category 5) Exempt (Category 1, 2, 3) Exempt (Category 4) Not Human Subjects Self-Certification Form

Expedited Review Categories Demystifying the CHR Approval Process Expedited Review Categories 1. Research with approved drugs or devices 2. Blood sampling (small amounts) 3. Noninvasive specimen collection 4. Noninvasive clinical procedure 5. Use of data or specimens collected for nonresearch purposes

Expedited Review Categories Demystifying the CHR Review Process Expedited Review Categories 6. Research recordings: voice, video, digital, or image recordings 7. Low risk behavioral research 8. Renewal of inactive research protocols or protocols that are essentially complete 9. Renewal of other minimal risk research protocols

Exempt Review Categories Demystifying the CHR Review Process Exempt Review Categories 1. Research conducted in established or commonly accepted educational settings 2. Research involving the use of educational tests, survey procedures, interview procedures, or observations of public behavior if they are anonymous or disclosure of individuals identity does not put them at risk DOES NOT APPLY to research with UCSF patients, children (minors), and prisoners 3. Interviews or surveys with public officials

Exempt Review Categories Demystifying the CHR Review Process Exempt Review Categories 4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Important note: Exempt Categories involve human subjects.

Third Step: Expedited Review The Expedited Review Application Third Step: Expedited Review Filling out the Expedited Review Application and Supplements

The Expedited Review Application Part 1: Administrative Requirements PI, Co-PI, Contact Person Study sites Funding Scientific Merit Key Personnel Financial Interests PI Signature

The Expedited Review Application Part 2: Study Design Synopsis vs. Design vs. Procedures Hypotheses Specific Aims Background vs. Preliminary Studies Design Statistical Analysis Sample Size

Expedited Review Application The Expedited Review Application Expedited Review Application Part 3: Procedures Clear description of research procedures What is the subject being asked to do for the purpose of the research study How does this compare or what is the subject being asked to do in addition to their normal standard of care Written in a way that can be replicated and understood by someone not in your field Tables, charts, or flow-diagrams may help explain the process and timeline

Expedited Review Application The Expedited Review Application Expedited Review Application Part 4: Alternatives Provide a discussion of the alternatives to participation Many times includes not participating!

Expedited Review Application The Expedited Review Application Expedited Review Application Part 5: Risks and Discomforts Description of risks Physical risk of blood draw to emotional risk of asking questions Steps to minimize risks Providing an opportunity for questions, follow recommended recruitment guidelines Maintaining confidentiality – data Maintaining privacy – individuals

Expedited Review Application The Expedited Review Application Expedited Review Application Part 5: Risks and Discomforts HIPAA section Identify source and personal health information that will be collected How will it be maintained and protected Disclosures Benefits – Overall risk/benefit analysis Explanation of why the benefit outweighs the risk of loss of confidentiality

Expedited Review Application The Expedited Review Application Expedited Review Application Part 6: Subject Information CHR Supplements? Inclusion & Exclusion Criteria Be specific Determining eligibility Non-regulated vulnerable populations HIV

Expedited Review Application The Expedited Review Application Expedited Review Application Part 7: Recruitment How, when, where, and by whom are potential subjects approached Respect for privacy Lack of pressure Unbiased presentation Who conducts initial contact? Written so that it can be understood by a reviewer that is not in your scientific field or works in your department

Expedited Review Application The Expedited Review Application Expedited Review Application Part 8: Informed Consent How, where, when and by whom informed consent will be obtained Ensuring understanding Consent Signed consent Waiver of signed consent Waiver of consent

Expedited Review Application The Expedited Review Application Expedited Review Application Part 9: Financial Considerations Will there be reimbursement for subjects? How will they be paid? Check? Cash? Gift Card? Is the amount coercive? Will subjects have to pay for any costs associated with the study?

Expedited Review Application The Expedited Review Application Expedited Review Application Part 10: Bibliography Part 11: Attachments Bibliography Provide a comprehensive list of references as it pertains to your application Attachments Sponsor’s protocol Survey instruments Recruitments and advertisement materials Consent forms

CHR Application Supplements The Expedited Review Application CHR Application Supplements Inclusion of Children and Minors Human Biologic Specimen Collecting and/or Banking for Future Research Waiver of Informed Consent/Authorization for Minimal Risk Research or Screening Disclosure of Investigator’s Financial Conflict of Interest IRB Approval Certification for UCSF Researchers Involving Non-UCSF Affiliated Sites More on HRPP website

Expedited Review Application: No Subject Contact The Expedited Review Application Expedited Review Application: No Subject Contact Differences from other applications Procedure section (Part 3) Biological specimen or data analysis involving identifiers Identify source and how collected Consent section (Part 6) Waiver of consent/authorization Does not include Alternatives, recruitment, payment and cost sections

Fourth step: Exempt Certification The Exempt Application Fourth step: Exempt Certification Filling out the Exempt Certification Application

Exempt Certification Application The Exempt Application Exempt Certification Application Part 1: Administrative Requirements PI, Co-PI, Contact Person Study sites Funding Key Personnel Financial Interests PI Signature

Exempt Certification Application The Exempt Application Exempt Certification Application Part 2: Study Specific Information for Category 1, 2, 3 Study purpose and design Describe human research subject population How human research subjects will be contacted Study instruments (surveys, questionnaires) How to inform subjects of research study –consent regulations do not apply to Exempt research but UCSF requires some form of information sheet. See Exempt Guidance on HRPP website How information obtained will be recorded and maintained PI Signature

Exempt Certification Application The Exempt Application Exempt Certification Application Part 2: Study Specific Information for Category 4 Briefly describe study activities Identify source of biological specimens and/or data Must be pre-existing at time of proposed research Can have access to identifiers if information is publicly available or information is recorded in a way that the biological specimen or data cannot be identified, directly or through identifiers linked to the subjects. DOES NOT APPLY to research with medical records

The Expedited and Exempt Application Fifth step: Consent Preparing a consent form, assent form, information sheet, or requesting waiver of consent

Three types of consent Signed consent Waiver of signed consent The Expedited and Exempt Application Three types of consent Signed consent Consent forms, parental consent forms, assent forms Waiver of signed consent Information sheet or verbal script Waiver of consent Waiver of Informed Consent/Authorization for Minimal Risk Research or Screening Supplement

Sixth step: Review Process The Expedited and Exempt Application Sixth step: Review Process

Review Process Expedited and Exempt Applications The Expedited and Exempt Application Review Process Expedited and Exempt Applications Assessment/screening   Review by IRB member(s) or Chair  Post-review correspondence  Approval 

What do CHR members consider when reviewing a new study? The Expedited and Exempt Applications What do CHR members consider when reviewing a new study? Risks to subjects are minimized Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk. Study utilizes procedures already performed for diagnosis/treatment Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result. Selection of subjects is equitable Inclusion/exclusion criteria are adequate Research purpose and setting is appropriate Recruitment process is fair

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval Make sure science is sound. Study should be reviewed by scientific merit, preferably by a group of peers, before submitting to the CHR Determine appropriate level of review, or if review is required.

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval Download and follow the most current CHR Application Forms and Consent Templates from the HRPP Website. Click on the links in the application for help. Check the HRPP Website to see which Application Supplements are needed for your particular study.

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval Consider the audience when writing application and consent documents Avoid acronyms if possible; if needed, spell out before first use. Write application with understanding that not all members are scientists, and few if any are experts in your field Consent documents should be written in lay language at a grammatical level appropriate for the prospective subjects. Avoid jargon, legalese, long complex sentences, and use of passive voice.

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval Strive for consistency within and among the various parts of the submission: Assure that all sections within the CHR Application are consistent with each other, i.e., the purpose, benefits and alternatives. Assure that all sections within the consent form are consistent (see above). Assure that the protocol and consent form are consistent. Use the same name for the subject groups throughout the application and consent documents.

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval Provide a detailed discussion of the recruitment and consent process. Include the who, what, when, where, and how of each. Submit copies of all recruitment materials and consent documents, including scripts.

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval Write a cover letter to: Explain and highlight any particularly difficult or sensitive issues to show that you have thought them though ahead of time, or ask for CHR input, or Inform the CHR is you have special time constraints i.e., if study is being sent in “just in time” for NIH funding or you have a patient waiting. Explain how many consent forms are being used if there are several. This is particularly important for research involving minors.

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval Do a final review of CHR Application and study documents. If you are preparing the application and are not the study PI, make sure the study PI has read the application. This is critical if the PI is your mentor.

Top Tips for Speeding Up Your CHR Approval Top Tips for Speeding Up CHR Approval Top Tips for Speeding Up Your CHR Approval If you have any questions about the process, call the CHR office at 476-1814 and ask to speak to the Analyst of the Day or e-mail chr@ucsf.edu Calls and e-mails will be returned within 24 hours. Bonus Tip: Get a separate CHR approval for each discrete study. Do not group related studies into a complicated application.

Ask Questions Ask your PI or Mentor Top Tips for Speeding Up CHR Approval Ask Questions Ask your PI or Mentor Call or email the CHR and ask for the Analyst of the Day Main CHR Line: 415-476-1814 Main CHR Email: chr@ucsf.edu www.research.ucsf.edu/chr/

Getting Answers After this Class For Researchers & Staff Status Checks   Full Committee Review Application   What is the CHR?   Reporting Requirements   Overview of Activities   Recruitment Guidance   Information for Prospective Volunteers   UCSF   Parnassus Committee   Office for Human Research Protections   General Information   General Information   General Information   Office   Roles and Responsibilities   Reporting Requirements   Parnassus Committee   Status Checks   Recruitment Guidance   Reporting Requirements   Office for Human Research Protections   UCSF Clinical Trials Seeking Volunteers   HRPP Quarterly Training   Office for Human Research Protections   Background   Full Committee Review Application   Background   Full Committee Review Application   UCSF   UCSF   HRPP Quarterly Training   Parnassus Committee   US and International   UCSF Clinical Trials Seeking Volunteers   US and International   Overview of Activities   US and International   Status Checks   Office   UCSF Clinical Trials Seeking Volunteers   Information for Prospective Volunteers   Roles and Responsibilities   Recruitment Guidance   Background   Overview of Activities   Information for Prospective Volunteers   HRPP Quarterly Training   What is the CHR?   Roles and Responsibilities   Office   What is the CHR?   UCSF Clinical Trials   UCSF Human Subject Protections: Basic Course   UCSF Clinical Trials   Information Security — Data Security   Food & Drug Administration   Food & Drug Administration   Responsibilities in Research Involving Human Subjects   Supplements   Do I Need to Apply to the CHR?   Food & Drug Administration   Federalwide Assurance Information   Consent Guidance   Frequently Asked Questions   Supplements   Frequently Asked Questions   San Francisco General Hospital Committee   UCSF Clinical Trials   PI and Clincical Research Coordinator Roles and Responsibilities   UCSF Human Subject Protections: Basic Course   Federalwide Assurance Information   UCSF Affiliates   UCSF Human Subject Protections: Basic Course   PI and Clincical Research Coordinator Roles and Responsibilities   HIPAA Guidance   Questions   Consent Guidance   CHR Review Process   UCSF Affiliates   Frequently Asked Questions   Frequently Asked Questions   Information Security — Data Security   Federalwide Assurance Information   UCSF Affiliates   PI and Clincical Research Coordinator Roles and Responsibilities   CHR Review Process   Questions   Supplements   Do I Need to Apply to the CHR?   Responsibilities in Research Involving Human Subjects   CHR Review Process   Frequently Asked Questions   Do I Need to Apply to the CHR?   HIPAA Guidance   Consent Guidance   Questions   San Francisco General Hospital Committee   Responsibilities in Research Involving Human Subjects   Information Security — Data Security   San Francisco General Hospital Committee   HIPAA Guidance   Frequently Asked Questions                                                                                               UCSF & HRPP Presentations, Classes, & Programs   Expedited Review Application   National Institutes of Health   HIPAA Definitions   Important Dates   UCOP and UC Schools   National Institutes of Health   HIPAA Definitions   Clinical Research Tools, Checklists, Templates   Additional UCSF Units   Applying and Reporting to the CHR   Applying and Reporting to the CHR   UCSF & HRPP Presentations, Classes, & Programs   UCSF & HRPP Presentations, Classes, & Programs   Experimental Subject's Bill of Rights   What Type of Application Should I Submit?   Expedited Review Application   Types of Research   Laurel Heights Committee   For Research Volunteers   Types of Research   Additional UCSF Units   National Institutes of Health   HIPAA Definitions   Important Dates   Clinical Research Tools, Checklists, Templates   HRPP Personnel   HRPP Personnel   What Type of Application Should I Submit?   Applying and Reporting to the CHR   HRPP Personnel   Laurel Heights Committee   Important Dates   What Type of Application Should I Submit?   Experimental Subject's Bill of Rights   ClinicalTrials.gov   For Research Volunteers   Clinical Research Tools, Checklists, Templates   ClinicalTrials.gov   ClinicalTrials.gov   Types of Research   Laurel Heights Committee   For Research Volunteers   UCOP and UC Schools   Experimental Subject's Bill of Rights   UCOP and UC Schools   Additional UCSF Units   Expedited Review Application   Universities and Medical Centers   CHR Chairs and Vice Chairs   CHR Meeting Dates   UCSF Seeking Clinical Trials Volunteers   QIU Staff and Contact Information   Use of Inactive Interventions in Place of Potentially Effective Therapy   Ethical Principles and Codes   SF Bay Area IRB Contacts   Additional Information   Other Sources   Mt. Zion Committee   Who Must Have CHR Approval Before Enrolling Human Subjects in Research   Use of Inactive Interventions in Place of Potentially Effective Therapy   Mt. Zion Committee   Vulnerable Subject Populations   Lay Language Resources for Preparing Consent Forms   Additional Information   Supplements   Supplements   Use of Inactive Interventions in Place of Potentially Effective Therapy   QIU Staff and Contact Information   Who Must Have CHR Approval Before Enrolling Human Subjects in Research   Vulnerable Subject Populations   CHR Meeting Dates   Lay Language Resources for Preparing Consent Forms   CHR Chairs and Vice Chairs   Additional Information   UCSF Seeking Clinical Trials Volunteers   Lay Language Resources for Preparing Consent Forms   Universities and Medical Centers   CHR Chairs and Vice Chairs   Ethical Principles and Codes   HIPAA Forms   Other Sources   Ethical Principles and Codes   Supplements   SF Bay Area IRB Contacts   HIPAA Forms   CHR Meeting Dates   Mt. Zion Committee   Vulnerable Subject Populations   Who Must Have CHR Approval Before Enrolling Human Subjects in Research   Other Sources   HIPAA Forms   UCSF Seeking Clinical Trials Volunteers   SF Bay Area IRB Contacts   Universities and Medical Centers   QIU Staff and Contact Information   History and Composition   Applications for Initial Review   Translation Services   CHR Meeting Dates   CHR Meeting Dates   Applications for Initial Review   UCSF Donating Tissue for Medical Research   Authorizations at Other Hospitals   History and Composition   National Conferences and Workshops   UCSF School of Medicine Clinical and Translational Research   UCSF Donating Tissue for Medical Research   Clinical Research Coordinator Group   Status Checks/Special Handling   Status Checks/Special Handling   UCSF School of Medicine Clinical and Translational Research   History and Composition   Status Checks/Special Handling   Financial Issues   CHR Meeting Dates   Federal Agencies   Clinical Research Educational Needs Assessment   SF Bay Area Hospitals   Clinical Research Coordinator Group   SF Bay Area Hospitals   Obsolete Application-Full and Expedited   SF Bay Area Hospitals   Authorizations at Other Hospitals   Authorizations at Other Hospitals   Federal Agencies   National Conferences and Workshops   Clinical Research Coordinator Group   National Conferences and Workshops   Obsolete Application-Full and Expedited   Financial Issues   Financial Issues   Translation Services   Clinical Research Educational Needs Assessment   UCSF Donating Tissue for Medical Research   Federal Agencies   Applications for Initial Review   Translation Services   Clinical Research Educational Needs Assessment   Obsolete Application-Full and Expedited   UCSF School of Medicine Clinical and Translational Research   Informed Consent for Research Subjects Who Do Not Read, Speak, or Understand English   Upcoming UCSF Training Opportunities   Member Responsibilities   Full Committee Review Application   Subscribe to CRCGROUP Email List   Modification Forms   CHR Guidelines - Table of Contents (1999)   Organizations   HIPAA Research Training   Modification Forms   CHR Guidelines - Table of Contents (1999)   Charge   Subscribe to CRCGROUP Email List   HIPAA Research Training   Subscribe to CRCGROUP Email List   Organizations   HIPAA Research Training   Upcoming UCSF Training Opportunities   Informed Consent for Research Subjects Who Do Not Read, Speak, or Understand English   Guidance for Reporting Concerns/Complaints   Organizations   Member Responsibilities   Informed Consent for Research Subjects Who Do Not Read, Speak, or Understand English   Modification Forms   Guidance for Reporting Concerns/Complaints   Charge   Full Committee Review Application   Charge   CHR Guidelines - Table of Contents (1999)   Full Committee Review Application   Quick Guide to Starting Your Research   Member Responsibilities   Upcoming UCSF Training Opportunities   Guidance for Reporting Concerns/Complaints   Quick Guide to Starting Your Research   Quick Guide to Starting Your Research   Campus Maps   Expedited Review Application   Reporting Form for Research Concerns/Complaints   Other HIPAA Links   Campus Maps   UCSF Federalwide Assurance of Compliance with DHHS   Other HIPAA Links   Educational Needs Assessment Survey   Other HIPAA Links   Listsserv Email Newsgroups   Meeting Details   Renewal Forms     UCSF Federalwide Assurance of Compliance with DHHS   HRPP Bulletin   Listsserv Email Newsgroups   Educational Needs Assessment Survey   Listsserv Email Newsgroups   Campus Maps   Reporting Form for Research Concerns/Complaints   Meeting Details       Expedited Review Application   Meeting Details   Educational Needs Assessment Survey   Reporting Form for Research Concerns/Complaints         HRPP Bulletin   UCSF Federalwide Assurance of Compliance with DHHS   HRPP Bulletin   Expedited Review Application   Renewal Forms   Renewal Forms       Letter to Sponsors About Membership   Exempt Application   Letter to Sponsors About Membership   Exempt Certification Forms   Exempt Application   Exempt Certification Forms   Questions   Exempt Certification Forms   Questions   Exempt Application   Letter to Sponsors About Membership   Questions   New California Laws   New California Laws   New California Laws   Emergency Use and Compassionate  Use   Reviewer Checklist   Reviewer Checklist   Administrative Review   Administrative Review   Emergency Use and Compassionate  Use   Emergency Use and Compassionate  Use   Administrative Review   Reviewer Checklist   Presentation Checklist   Presentation Checklist   Modifications   Adverse Event Reporting   Presentation Checklist   Adverse Event Reporting   Modifications   Modifications   Adverse Event Reporting     Protocol Violations or Incident Reporting   Renewals   Renewals   Protocol Violations or Incident Reporting   Renewals       Protocol Violations or Incident Reporting   Administrative Review   Administrative Review   Emergency Use and Compassionate Use   Emergency Use and Compassionate Use   Administrative Review   Emergency Use and Compassionate Use   Human Stem Cell Supplements   Adverse Event Reporting   Adverse Event Reporting   Human Stem Cell Supplements   Human Stem Cell Supplements   Adverse Event Reporting   Protocol Violations or Incident Reporting   Sample Consent and Assent Forms   Sample Consent and Assent Forms   Sample Consent and Assent Forms   Protocol Violations or Incident Reporting   Protocol Violations or Incident Reporting     HIPAA Forms     HIPAA Forms   CHR Review Process     HIPAA Forms   CHR Review Process   CHR Review Process   Experimental Subjects Bill of Rights   Experimental Subjects Bill of Rights   Experimental Subjects Bill of Rights                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Getting Answers After this Class                                                                                                                                                                                                                                                                                                                                                                                                                                                                   For Researchers & Staff For Research Volunteers About the Committee on Human Research Contact Information Applying and Reporting to the CHR Applications and Forms Recruitment and Consent Process UCSF Guidance on Research Topics and Issues Working with the VAMC CHR Member Information       For Researchers & Staff For Research Volunteers About the Committee on Human Research Contact Information Applying and Reporting to the CHR Applications and Forms Recruitment and Consent Process UCSF Guidance on Research Topics and Issues Working with the VAMC CHR Member Information       For Researchers & Staff For Research Volunteers About the Committee on Human Research Contact Information Applying and Reporting to the CHR Applications and Forms Recruitment and Consent Process UCSF Guidance on Research Topics and Issues Working with the VAMC CHR Member Information       Contact us: Phone: 415-476-1814 Fax: 415-502-1347 e-mail: chr@ucsf.edu Box 0962 New Education Requirement Deadline                                                                                                                                    Contact us: Phone: 415-476-1814 Fax: 415-502-1347 e-mail: chr@ucsf.edu Box 0962 New Education Requirement Deadline                                                                                                                                    Contact us: Phone: 415-476-1814 Fax: 415-502-1347 e-mail: chr@ucsf.edu Box 0962 New Education Requirement Deadline                                                                                                                                                                        About the Quality Improvement Unit Education and Training Status Checks and                          HIPAA and Human Research        Federal Regulations and Guidance Other Useful Links          Working with Other Institutions and Units            Organization                                     About the Quality Improvement Unit Education and Training Status Checks and                          HIPAA and Human Research        Federal Regulations and Guidance Other Useful Links          Working with Other Institutions and Units            Organization                                     About the Quality Improvement Unit Education and Training Status Checks and                          HIPAA and Human Research        Federal Regulations and Guidance Other Useful Links          Working with Other Institutions and Units            Organization   What's New Research News Mission Statement Program Description New Investigator Quick Guide   What's New Research News Mission Statement Program Description New Investigator Quick Guide   What's New Research News Mission Statement Program Description New Investigator Quick Guide Office of Research | Search | Feedback | Site Map | Help | Top of Page © Copyright UC Regents 2003-2007. All Rights Reserved. Contact Us. Page updated: January 8, 2009 Office of Research | Search | Feedback | Site Map | Help | Top of Page © Copyright UC Regents 2003-2007. All Rights Reserved. Contact Us. Page updated: January 8, 2009 Office of Research | Search | Feedback | Site Map | Help | Top of Page © Copyright UC Regents 2003-2007. All Rights Reserved. Contact Us. Page updated: January 8, 2009

Topics from Survey Request Getting Answers After This Class Topics from Survey Request Pre existing data and how to get it published What to look for when preparing an application for International work Research with other sites Collaborative studies that only involve laboratory analysis How long does it take to get an approval? Documentation for Exempt applications

More Resources CTSI: Clinical and Translational Science Institute Getting Answers After This Class More Resources CTSI: Clinical and Translational Science Institute http://ctsi.ucsf.edu/ RKS: Regulatory Knowledge and Support http://ctsi.ucsf.edu/rks/request/ Marlene Berro Marlene.Berro@ucsf.edu; 476-3426 BREAD: Biostatistics, Research Ethics and Design Program CtsiBread@ucsfmedctr.org, 502-7893