Human Research Protection Program Training

Human Research Protection Program Training
Lisa Voss, MPH, CIP Assistant Director, HRPP Quality Improvement Unit 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

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

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

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

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

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

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

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

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

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

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

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?

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

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

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 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 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 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 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 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 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 CHR Approval Top Tips for Speeding Up Your CHR Approval If you have any questions about the process, call the CHR office at and ask to speak to the Analyst of the Day or Calls and s 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 the CHR and ask for the Analyst of the Day Main CHR Line: Main 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 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 List HIPAA Research Training Subscribe to CRCGROUP 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 Newsgroups Meeting Details Renewal Forms UCSF Federalwide Assurance of Compliance with DHHS HRPP Bulletin Listsserv Newsgroups Educational Needs Assessment Survey Listsserv 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: Fax: Box 0962 New Education Requirement Deadline Contact us: Phone: Fax: Box 0962 New Education Requirement Deadline Contact us: Phone: Fax: 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 All Rights Reserved. Contact Us. Page updated: January 8, 2009 Office of Research | Search | Feedback | Site Map | Help | Top of Page © Copyright UC Regents All Rights Reserved. Contact Us. Page updated: January 8, 2009 Office of Research | Search | Feedback | Site Map | Help | Top of Page © Copyright UC Regents 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 RKS: Regulatory Knowledge and Support Marlene Berro BREAD: Biostatistics, Research Ethics and Design Program

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