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I.	RESEARCH NEWS AND INFORMATION
	A. STANFORD HRPP (Stanford, LPCH, SHC, VAPAHCS, PAIRE)
	1. Stanford Has Received Full AAHRPP Accreditation
	2. Updates Regarding Investigator Sponsored Trials (ISTs) and Consent Observation
	3. VA Palo Alto AAHRPP Accreditation
II.	STANFORD HRPP UPDATES
	A. RCO-Related News
	1. eProtocol Help
	B. Forms and Web Updates
	1. Determination of Human Subjects Research Application
	2. Short Form Consent Templates
	3. Continuing Review Application (Renewal Application)
III.	FREQUENTLY ASKED QUESTIONS

I. RESEARCH NEWS AND INFORMATION

A. State and Local (Stanford, VA, LPCH, SHC, Santa Clara County)

1. Stanford University has received full AAHRPP Accreditation - Stanford University has received full accreditation of its human research protection program (HRPP) through the Association for the Accreditation of Human Research Protection Programs (AAHRPP). For more information please see the March 22, 2006 issue of the Stanford Report, published by the Stanford News Service and the AAHRPP press release.

The STANFORD Human Research Protection Program (HRPP) affiliated organizations are:
• Stanford University
• Stanford Hospital and Clinics (SHC)
• Lucile Packard Children’s Hospital at Stanford (LPCH)
• Veterans Affairs Palo Alto Health Care System (VAPAHCS)
• Palo Alto Institute for Research and Education (PAIRE)

2. Updates Regarding Investigator Sponsored Trials (ISTs) and Consent Observation - Please see the message below from Arthur Bienenstock, Vice Provost and Dean of Research and Ann M. Arvin, Associate Dean of Research:

Stanford University's Human Research Protection Program is now fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). That signifies that we meet their national standards to protect human research participants. As part of meeting their standards, we must provide additional oversight in two areas.

1) Investigator Sponsored Trials (ISTs)
When physicians hold their own Investigational New Drug (IND) number or Investigational Device Exemption (IDE) number, they are responsible for fulfilling all regulatory functions usually performed by sponsors, including reporting requirements. SPCTRM will be working with investigators and their research team members, so that they are aware of their obligations. After SPCTRM has completed their education, the Research Compliance Office staff will contact investigators to schedule an audit. The list of sponsor obligations is found in http://humansubjects.stanford.edu/research/documents/SponsorRequirements.doc

2) Consent Observation
A Stanford IRB can request observation of a research participant being consented in certain selected instances. The Research Compliance Office will observe and report findings back to the IRB. Protocols selected for observation will include those that involve:
o High risks to participants
o Particularly complicated procedures or interventions
o Potentially vulnerable populations (e.g., ICU patients, children)
o Study staff with minimal experience in administering consent to potential study participants, or
o Other situations where the IRB has concerns that consent process might not be proceeding well.
The consent observation procedure is found at http://humansubjects.stanford.edu/research/documents/ObservationConsentingProcess.pdf

In addition, SPCTRM and the Stanford University Internal Audit Department will coordinate the timing of the education sessions and future audits related to budget, billing and regulatory practices.

Please let us know if you have suggestions about how we can best implement these AAHRPP requirements. You may also contact Kathy McClelland, Research Compliance Director (650-723-4697) with questions and comments.

3.VA Palo Alto and AAHRPP Accreditation - Although the VA Palo Alto Health Care System (VAPAHCS) had received preliminary NCQA Accreditation, which was to be complimented by its affiliate, Stanford University's accreditation by AAHRPP, VAPAHCS will now seek accreditation through AAHRPP. AAHRPP was awarded a contract by the Department of Veteran Affairs (VA) for the accreditation of all VA Human Research Protection Programs. The contract took effect on December 1, 2005. NCQA's contract with the VAPAHCS has subsequently expired. The VAPAHCS will undergo the AAHRPP accreditation process in early to mid 2007.

II. STANFORD IRB UPDATES

A. IRB-related news

1. eProtocol Help - Information on the eProtocol System is available on the RCO web site that provides details on how to avoid some of the most commonly reported difficulties experienced by our system users. For additional information, please contact Kathleen M. Garcia, eProtocol Senior Technologist, (650) 723-5481.

B. IRB Forms and Web Updates

1. Determination of Human Subject Research Application - Federal regulations require IRB review of all human subject research. Some categories of research are difficult to discern as to whether they qualify as human subject research. Therefore, the IRB has established policies and procedures to assist in this determination. Please complete this form and return it to the IRB if you want the IRB to determine whether your activity constitutes "human subject research".

2. Short Form Consent Templates - Written consent documents should embody, in language understandable to the participant, all the elements necessary for legally effective informed consent.  Participants who do not speak English should be presented with a consent document written in a language understandable to them.  The Stanford HRPP and OHRP strongly encourage the use of a full consent form, translated into the participant’s language, whenever possible. 

Stanford's IRBs request translation of full informed consent documents into a subject's native language when it is known that non-English speaking subjects will be enrolled in a study, and when the study is likely to involve ongoing interventions or interactions over an extended period of time.

If investigators are uncertain whether non-English speaking subjects might be enrolled in a study, or believe there might be a very small number of subjects (< 5) who will not understand English, the regulations allow the use of a short form (in the subject's language) and a summary document (in English).  Please see Memo from the IRB Chairs for additional information on when it is acceptable to use the short form consent.  Please note that, whether using a full translated consent form or the short form, the participant, or their legally authorized representative, should be given adequate time to make an informed decision regarding participation in the research. 

To use the Short Form Consent PROCESS you must:

IRB Approval:

• Obtain prior IRB approval and provide to the IRB: 
  1. Summary document (e.g., the English language full informed consent)
  2. Short form consent document (foreign language and English versions)
• Describe the use of each short form consent process with any new protocol application.
• Submit a modification (revision) application (http://hs.stanford.edu) if you want to use a short from consent in a currently approved protocol.

Signature Requirements:

• Ensure that the short form document is signed by the participant (or the participant's legally authorized representative [LAR])
• Ensure that the summary is signed by the person obtaining consent as authorized under the protocol
• Ensure that the short form document and the summary document are signed by a witness fluent in both English and the language of the participant. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.

Templates:

• Chinese Short Form Consent
• English Short Form Consent
• Farsi Short Form Consent
• Japanese Short Form Consent
• Korean Short Form Consent
• Russian Short Form Consent
• Spanish Short Form Consent

For more information on this topic, see the following OPRR Guidance Information (1995).

3. Continuing Review Application - Please note that the Renewal Application will now be referenced as the Continuing Review Application. See Continuing Review Application Nonmedical and the Continuing Review Application Medical.

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III. FREQUENTLY ASKED QUESTIONS

1. Q: I have a group of students who will be submitting human research protocols to the IRB. What resources are available?
A: To request classes and presentations geared towards your needs, please contact IRBeducation@Stanford.edu. Also, to request individual appointments, please contact IRBeducation@Stanford.edu. For various documents, please see our Guidance Page.

2. Q: What is the Institutional Review Board (IRB)?
A: The IRB is the committee that reviews and approves protocols for the use of human subjects in research. Federal regulations require that the IRB membership represent a variety of backgrounds, training and experience. At least one IRB member must have no formal or family connection with the University. At least one member must be a non-scientist.

3. Q: I want to submit a new protocol application. When is the next due date?
A: The next due date for protocol submissions can be found on our Web site at the following link: http://humansubjects.stanford.edu/general/APMeeting.pdf.

4. Q: How long does it take for a protocol to be approved?
A: The IRB will review all protocols that are filled out correctly and completely within approximately 4 - 6 weeks.

5. Q: I am trying to log on to the CITI Training and it is not recognizing my SUNet ID. What’s wrong?
A: Before the system will recognize you as a user, you must first register for the course. Please click on “Register for the CITI Course” in order to start the training.

6. Q: Can I make changes to my approved protocol?
A: If you would like to make changes to a protocol that has already been approved, you will need to submit a Revision Application and wait for IRB approval before implementing the change.

7. Q: How can I avoid protocol procsssing delays?
A: In the eProtocol system, please make sure that all email addresses are valid when submitting a protocol. Without valid email addresses the IRB will not be able to effectively communicate with the investigator. Also, in the eProtocol system, please remember to attach all necessary documents in the last section of the application (e.g., advertisements, surveys, questionnaires, Investigator's Brochure, Sponsor's protocol, etc.)

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