Section revised: 6/1/13  

STANFORD has and follows written policies and procedures that establish a safe, confidential, and reliable channel for current, prospective, or past research participants or their designated representatives that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol or plan. (AAHRPP Element I.4.A.)

Researchers and Research Staff have a process to address participants’ concerns, complaints, or requests for information. (AAHRPP Element III.1.G.)

Consent Form Requirements

The IRB requires that all consent forms include information on how to contact the investigator(s) conducting the research study.  Participants are instructed to call the investigators if they have any questions about the research, about their rights as a research participant, or if they believe they have suffered a research-related injury.  Each consent form must also include telephone numbers for the IRB (a local number and a toll free number).  The IRB contact information affords current or past research participants or their designated representatives a means to contact an informed individual who is independent of the research team.  The IRB also serves as a conduit for receiving information from any party who is not satisfied with the manner in which a study is (or was) being conducted, or if any party has any concerns, complaints or general questions about research or the rights of research participants. 

Consent form templates, available on the Human Subjects Research website, include instructional text and verbatim language for the inclusion of the investigator’s contact information and IRB telephone numbers under the consent form heading “Contact Information.”  The IRB’s physical address is included in the consent form template to also allow for written communication.

Recruitment Material Requirements

The IRB requires specific contact information to be included in participant recruitment materials – flyers, newspaper ads, newsletters, and web postings.  Guidance Advertisements: Appropriate Language for Recruitment Material provides appropriate language to include in recruitment material. 

All recruitment materials must include the appropriate contact information for the investigator(s) conducting the study. The IRB reviews all recruitment materials, and the addition of IRB contact information is required when appropriate.   

Telephone (Screening) Scripts

The IRB requires investigator and IRB contact information be included in telephone scripts.  Telephone scripts are often used to screen prospective participants.  Like the consent forms, telephone scripts must include telephone numbers for IRB (a local number and a toll free number), as well as telephone numbers for the investigators.  This contact information provides prospective participants with channels of communication to the investigators and the IRB for questions, concerns, input, information or complaints.  

Responding to Contacts from Participants or Others

Prospective Participants

Calls from prospective participants interested in medical research are generally forwarded to Spectrum for follow up with the interested caller.  Spectrum tracks calls on a study basis.

Calls from prospective participants interested in nonmedical research are generally received and handled by the IRB 2 (Nonmedical) Manager.

All other contacts are referred to the HRPP Associate Director.

Participant Concerns

Concerns of research participants are followed up by the HRPP Associate Director who calls the individual to gather more information.  As appropriate, concerns may be forwarded to the IRB 2 (Nonmedical) Manager.  Minor concerns are generally resolved by a phone call.

More complex concerns are followed up by the HRPP Associate Director with the relevant IRB Chair and others in the Research Compliance Office.

Website

The Human Subjects Research website includes participant outreach information addressing the general rights of research participants and provides links to various research resources.  Additionally, the website has a toll free number listed for participants to ask questions, offer input, raise concerns or complaints about research, a research related injury, or any question about the rights of research participants.

 

The Office of General Counsel also has instructions to forward callers seeking human research information to the HRPP Associate Director in the RCO.