FAQs

Questions? Contact Office of Ethics and Compliance

Overview

Many Frequently Asked Questions for each area the Office of Ethics & Compliance supports can be found below. Don't see an answer to your question? Contact us at [email protected].  

ClinicalTrials.gov

The UCSF Clinical Trials Registration & Reporting policy requires registration of all clinical trials (all phases and intervention types) in the ClinicalTrials.gov Protocol Registration and Results System (PRS) before enrollment of the first subject. The UCSF policy complies with the Food and Drug Administration Amendments Act (FDAAA), National Institutes of Health (NIH), International Committee of Medical Journal Editors (ICMJE), and Center for Medicare and Medicaid Services (CMS) definitions of a clinical trial.

  • For ClinicalTrials.gov user accounts and questions, please email the ClinicalTrials.gov Regulatory Support Team at [email protected]. 
  • If you are a researcher affiliated with the Helen Diller Family Comprehensive Cancer Center (HDFCCC), please contact the HDFCCC Research Compliance Team for assistance at [email protected].

The "Creating a Study Record in ClinicalTrials.gov" document provides institution-specific guidance for UCSF investigators, plus selected tips on how to initiate a new record by filling in a series of data entry screens. In addition, the “Help” and “Definitions” links embedded throughout the Protocol Registration and Results System (PRS) aid users with navigation and completion.

The "Creating a Study Record in ClinicalTrials.gov" document provides institution-specific guidance for UCSF investigators, plus selected tips on how to initiate a new record by filling in a series of data entry screens. In addition, the “Help” and “Definitions” links embedded throughout the Protocol Registration and Results System (PRS) aid users with navigation and completion.

ClinicalTrials.gov has the following resources to help researchers, which we strongly recommend that you review prior to registering a study:  

Although you are not required to register your observational study, you can voluntarily register it.

If you choose to register your observational study, you must maintain the record as if it were a clinical trial, meaning:

  • You will be expected to update your record within 30 days of a change to any of the following: Overall Recruitment Status and Completion Dates.
  • You will be expected to update or verify the accuracy of your record at least once every 12 months.

The Primary Completion Date is the date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.

The Study Completion Date is the date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.

Note: both dates are determined by the last date data were collected, not the date data were analyzed, the date the study manuscript was published or the date the study closed with the IRB.

Yes, results reporting is required if your study is:

  • A clinical investigation of an FDA-regulated product. Otherwise known as an Applicable Clinical Trial (ACT) or Probable Applicable Clinical Trial (pACT) per FDAAA. (For complete definitions of ACTs, ClinicalTrials.gov FAQs); or,
  • A NIH funded clinical trial (NIH Clinical Trial Requirements for Grants and Contracts); or,
  • Funded by a grant agency that requires results reporting on ClinicalTrials.gov (e.g., PCORI).

Results must be submitted for ACTs no later than 12 months after the Primary Completion Date of the trial for Clinical Trials subject to FDAAA or funded by NIH.

ClinicalTrials.gov has the following resources to help researchers, which we strongly recommend that you review prior to entering results:

FDA Regulatory Support

You DO need an IND to study an FDA approved drug UNLESS your study meets ALL of the following IND exemption criteria found at 21 CFR 312.2(b)(1):

(i) The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;

(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;

(iii) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;

(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 [FDA requirements for IRB review] and with the requirements for informed consent set forth in part 50 [FDA requirements for Informed Consent]; and

(v) The investigation is conducted in compliance with the requirements of §312.7 [no advertisement/marketing].

Additional resources regarding IND exemption can be referenced here.

Contact the UCSF FDA Regulatory Support Team at [email protected]. Final decision regarding whether you are required to obtain an IND may be made only by FDA or an IRB. 

No. Only lawfully marketed drugs are eligible for an IND exemption. While a dietary supplement is lawfully marketed, it is not marketed as a drug.

An IND application to FDA is required if a clinical investigation is intended to evaluate the dietary supplement's ability to diagnose, cure, mitigate, treat, or prevent a disease. Contact [email protected] for specific guidance.

FDA defines a medical device as:


An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and​​​​​​ 

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

An investigational medical device is a device that is not lawfully marketed as a medical device. Or, a medical device that is lawfully marketed, but will be used in clinical investigation outside its cleared or approved indications.

You will need to obtain Institutional Review Board (IRB) approval. We recommend that you review the Invesitgational Device Exemption (IDE) Overview to decide what type of regulatory determination you need to request in your IRB application. The IRB will review your application and make a device determination for your investigational medical device. Only the FDA or an IRB can grant IDE exemptions or Non-Significant Risk (NSR) determinations.

FDA has a list of medical device databases available on their website. Depending on the risk of the device, it may have received a Premarket Approval (PMA), 510k clearance, or De Novo. We recommend using only part of the name of the device or the manufacturer to successfully search the databases. 

Additional device resources can be referenced here.

Conflict of Interest in Research

Holding a financial interest does not necessarily mean that a conflict exists.  If a conflict is found to exist, the Conflict of Interest Advisory Committee (COIAC) attempts to manage and mitigate the conflict(s). 

For research funded by the Public Health Service (PHS--including NIH), submit disclosures in COI-Smart (via MyAccess).  For non-governmental research funding, Principal Investigators will disclose on a Form 700U.  For non-PHS governmental research, disclosures are made on the UCSF COI PI Certification Form.  If you have a financial interest related to an IRB on which you are participating or for any questions regarding disclosures, instructions, requirements, please contact [email protected].

Any researcher listed as an "investigator" (responsible for the design, conduct, or reporting) of a Public Health Service (PHS--including NIH) grant is required to complete a COI-Smart (financial disclosure).  If you are not sure why you were listed as an investigator or believe this is an error, please reply to the e-mail and COI staff will assist you.

Please contact [email protected] and we will set up your account.

IF you have submitted a questionnaire in the past, you must update your "submitted" questionnaire annually or within 30 days of a new financial interest..  You can do this by folllowing the instructions sent to you by COI (or contacting [email protected] for the instructions), which includes clicking on the "submitted" link to access your existing questionnaire.

The Conflict of Interest Advisory Committee (COIAC) reviews financial interests with a private sponsor of research on a case by case basis. Contact [email protected] with any questions. It is always best to be proactive in addressing potential conflict of interest issues (prior to engaging in the research or beginning the financial interest).

The instructions for the 700U address many common questions regarding what should be reported. Please note that the 700U requires that you disclose personal financial interests with the sponsor in the previous 12 months. Funding/reimbursements that have been received through the University (i.e. sponsored research agreement) are not considered personal financial interests.

General Conflicts of Interest and Commitment

Generally speaking:

  • You should disqualify yourself from participating in any decisions on behalf of UC that are related to entities in which you have a personal financial interest.
  • You are expected to act with integrity and good judgment with those individuals and entities doing business or seeking to do business with the University.

You should disqualify yourself from making, participating in making or influencing any decisions to be made on behalf of the University.

You may not participate in the process of reviewing or decision-making on any matter concerning the appointment, promotion, salary, retention, termination, or other management decisions or personnel related decisions regarding a near relative.

1)  The first step would be to discuss the new activity with your department chair and/or Dean's office.  2) If intellectual property matters should be considered, please contact Office of Technology management (OTM): https://innovation.ucsf.edu/venture/office-technology-management. 3) If you conduct research and have discussed your new financial interest with your department, please contact [email protected] to discuss COI in research disclosures and considerations.  A reminder that if you conduct Public Health Service (including NIH) funded research, you are required to update your financial disclosure (COI-Smart) within 30 days of acquiring the new financial interest (this includes equity--even if valued at zero).  If you need assistance with/instructions for updating your COI-Smart disclosure, please contact [email protected].

1)  The first step would be to discuss with Labor and Employee Relations (LER) representative.  If you are not sure who your LER rep is, you can get the contact information from your Human Resources contact.  2) If intellectual property matters should be considered, please contact Office of Technology management (OTM): https://innovation.ucsf.edu/venture/office-technology-management. 3) If you conduct research and have discussed your new financial interest with LER, please contact [email protected] to discuss COI in research disclosures and considerations.  A reminder that if you conduct Public Health Service (including NIH) funded research, you will want to update your COI-Smart disclosure within 30 days of acquiring the new financial interest (this includes equity--even if valued at zero).  If you need assistance with/instructions for updating your COI-Smart disclosure, please contact [email protected].

Please contact the Office of Healthcare Compliance and Privacy:  https://ohcp.ucsf.edu/contact-us

Due to the varying policies/requirements for each of the disclosure systems, the systems do not share information and are managed by different offices.  For questions regarding OATS, please contact your department/school.  Additional information can be found at: https://facultyacademicaffairs.ucsf.edu/online-systems/OATS.  For questions regarding COI-Smart, please contact [email protected].

If you conduct Public Health Service (PHS)-sponsored research (including NIH), you are required to complete the Conflict of Interest for Researchers (COIR) training. The training is required every 4 years. Please log into Learning Management System (LMS) via MyAccess to access the training or your training records.

Please feel free to e-mail [email protected].

Export Control

Export controls are federal restrictions related to the access, use and transfer of certain technologies or items, both in the U.S. and abroad. These regulations provide limits on our use of certain technologies as well as exceptions and exemptions which UCSF complies with.

For purposes of export control regulations, export refers to any physical, visual, oral, electronic, or virtual transfer, release or access of restricted materials or information. Disclosure or access of restricted materials or information, including source code, to a foreign national inside the U.S. is considered a “deemed” export.

UCSF is obligated to comply with the University of California policy.  

The lists of controlled items and technology are extensive. UCSF research at high risk of using controlled materials includes:

  • Life Sciences research (particularly biotech and biomedical engineering)
  • Advanced computing, microelectronics and telecommunications research
  • Information security and encryption research, including on mobile devices
  • Research involving use of sensors, sensor technology, imaging

Comprehensive lists of controlled materials and research programs

Regulation: Export Administration Regulations
List: Commerce Control List
Citation: 15 C.F.R. § 774

Regulation:  International Traffic in Arms Regulations
List:  U.S. Munitions List
Citation: 22 C.F.R. § 121

Regulation:  Nuclear Regulatory Commission
List:  Export and Import of Nuclear Equipment and Material
Citation: 10 C.F.R. § 110.8-9a

Regulation:  Assistance to Foreign Atomic Energy Activities
List:  Special Nuclear Materials
Citation: 110 C.F.R. § 810

 

Contact UCSF’s Export Control Officer for a review to see if a license or documented license exception is required for your specific use.

Not for most university research activities, as UCSF only performs “Fundamental Research”, or research, the results of which are published, intended to be published or information made available in the public domain. However, researchers may receive or purchase restricted materials for use during the performance of their research. Researchers may also enter into Non-Disclosure Agreements that involve the exchange of controlled materials. Some foreign nationals may require a license to access and/or use these materials.

If you are unsure whether you may be receiving and/or purchasing controlled materials for access or use by a foreign national, reach out to [email protected] for a determination.

You can help promote a fundamental research environment by not entering into written or verbal agreements that restrict publication or the participation of foreign nationals.

Non-restricted Information provided during the webinar/web conference is considered to be in the public domain or publicly available and not subject to export control regulations, so long as it is presented at a webinar that is indeed open to the public, such that all technically qualified members of the public are eligible to attend, and that attendees are permitted to take notes of the proceedings and presentations. Material which is restricted in any way including proprietary information received under a non-disclosure agreement must not be included.  It is recommended that you contact [email protected] to review your specific circumstance before proceeding.

The export control regulations include categories of information that are considered "publicly available" (under the EAR), "public domain" (under the ITAR), available to the public without any restrictions.  Each set of regulations has its own definition, but generally, information that is intended for public dissemination without restriction, or in the pubic domain including information that arises through fundamental research where the information is ordinarily published, information that is already published, educational materials, and even technical information disclosed in patent applications, is not subject to the export control regulations.

Some biological materials require export licenses before being shipped outside the U.S and/or before being accessed or used by foreign nationals within the U.S. Materials of concern include attenuated forms of bacteria, toxins, viruses, and fungi or animals or material containing those items that are on the Select Agents and Toxins List. Minuscule quantities of genomic elements may still be controlled. Contact the Export Control Officer at [email protected] if you have any planned international shipments of these items so that the required export licenses can be requested. Note that receiving a license may take 6 weeks or longer if approved.

If you know or believe that the item or commodity intended for international shipment is controlled, contact [email protected] for a license determination and to discuss options for either obtaining a license, using a license exception, or other options.

You should consult with the biosafety office, export control office, and OTMA. The shipping, receipt, and handling of such items may require import permits and licenses and material transfer agreements. These offices can advise on licensing and any other handling requirements.