Medical Research

• Human Subject Research
• Protocol submission
• Required study registration on Stanford Clinical Trials Web Site
• Sample application questions
• Schedule of submission deadlines and meeting dates.
• Protocol review
• Recruitment
• Sponsor-Investigator research
• Downloadable forms
• Emergency use of a test article

Human Subject Research

All protocols involving both "research" or "clinical investigations" and "human subjects" must be reviewed and approved by the IRB before recruitment and data collection may start.

For some protocols it might be difficult to tell whether they qualify as human subject research. Please consult the guidance Does My Project Need IRB Review? For further assistance contact the Research Compliance Office, or submit a Determination of Human Subject Research - Application to the IRB.

If the proposed activity clearly does not involve "research" or "clinical Investigations" and "human subjects", it does not require submission to the IRB. In some circumstances, an investigator might have need for a written determination from the IRB that an activity does not constitute "human subject research" and is not subject to IRB review. In such cases, a Determination of Human Subject Research - Application to the IRB must be submitted.

Primary concerns of the IRB are that risks are minimized for subjects and are reasonable when compared to benefits, participant selection is equitable, privacy and confidentiality are protected, participants are adequately informed of what their participation will entail (e.g., risks and benefits) including written and signed informed consent in most cases, and a plan for monitoring research is developed. This is true for both medical and non-medical protocols.

The Human Research Protection Program Manual contains policies and procedures for researchers, administrators, students, participants, and staff involved in human subject research. All researchers working with human subjects must complete a tutorial on the protection of human subjects in research. (See related policy.)

top

Protocol Submission

Protocol submission is done online, using the "eProtocol" system. To use eProtocol, you need a SUNet ID, Internet Explorer (for PCs) or Safari (for MACs), and all pop-up blockers must be off.  See eProtocol Help and Tips for Success in eProtocol for more information.
Before a research protocol can be approved by the IRB, investigators must first identify the appropriate Review Type, i.e., whether the protocol qualifies for Exempt, Expedited or Regular review.
Once the review type has been identified, the application can be completed online using eProtocol.
To assist in preparing for an eProtocol submission, text-only samples of the medical protocol applications are available:
       -  Regular review
       -  Expedited review
       -  Exempt

A schedule of submission deadlines and meeting dates is available.

top

Required Study Registration on Stanford Clinical Trials Web Site

Policies of the ICMJE (International Committee of Medical Journal Editors) require registration of any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes:
Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). 
Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. 

Registration is not required for purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator).

Questions?

Cancer trials: The Cancer Clinical Trials Office (CCTO) is providing registration services for all cancer trials.  For questions or assistance on cancer study registration, contact Ellen DiNucci (CCTO Recruitment Specialist) at (650)725-2839.

Trials that do not involve cancer research: Contact Linda Walker at (650)498-7425.

Protocol Review

Protocols are reviewed by the IRB staff and IRB Members. Comments and questions are sent to the Protocol Director to be addressed prior to a convened meeting. All Regular protocols must be presented, discussed and voted on at a convened meeting of the IRB. This process generally takes approximately 4-6 weeks.

Under no circumstances may research begin until the Protocol Director has been notified of confirmation of exemption, or IRB approval of an Expedited or Regular protocol. Approval may be confirmed by email, phone, Interdepartmental Campus Mail (I.D.), or U.S. Mail.

Protocol Status and Historical Information

The eProtocol system is now the system of record, and should be accessed for information on current protocols.
Some historical information about events prior to 3/8/08 is available from the previous system - <click here>.

Recruitment

All protocols involving "research" or "clinical investigations" and "human subjects" must be reviewed and approved by the IRB before any recruitment activity. Screening and recruitment are the first step of the consent process. See the Recruitment page for more information.

Sponsor-Investigator Research

Stanford IRB policies (HRPP Policy Chapter 5.6) require additional oversight on research when the Stanford (SU, SHC, LPCH, VA) investigator holds the IND or IDE.  An investigator who holds an IND or IDE must perform the FDA mandated responsibilities for both an investigator and a sponsor, including communicating information to the FDA about the study. Prior to approving a protocol that involves a sponsor-investigator, the IRB must be satisfied that the sponsor-investigator is knowledgeable about his/her responsibilities and has adequate policies and procedures in place to comply with the FDA regulatory requirements.  For more information on the FDA and IRB requirements and contact information for assistance see:

• Holder of an IDE(investigational device exemption)
• IDE application (FDA website)
• Holder of an IND(investigational new drug)
• IND Forms and Instructions (FDA/CDER website) including:
  • FDA 1571 Investigational New Drug Application
  • FDA 1572 Statement of Investigator
  • Instructions for completing FDA forms 1571 and 1572
  
  
  top

Downloadable Forms

Sample Consents, Assents

The Medical Consent page contains templates, including versions for the VA Palo Alto Health Care System, that may be modified or expanded for particular protocols.

Reviewers use an Informed Consent Checklist. This information might help investigators to better understand what the IRB looks for in a consent form, and why.

Report Forms, and other forms - Medical Forms page.