StanfordUniversity Required Questions for the Protocol Application

Research Compliance Office Nonmedical

  1. Describe steps taken to minimize the possibility of coercion or undue influence.
  1. Provide an assessment of the importance of the knowledge expected to result from this study.
  1. If you have indicated “Other” as the study location, please provide the following information:
  2. Name of the site,
  3. Contact name for the site with phone number/email address,
  4. Has the site granted permission for the research to be conducted?
  5. Does the site have an IRB?
  6. If yes, will that IRB approve the research?

RESOURCES

  1. Will you have access to a population that will allow recruitment of the required number of participants?

Please explain and justify.

  1. Will you have sufficient time to conduct and complete the research?

Please explain the time required and justify.

  1. Will you have adequate numbers of qualified staff? Please explain and justify the number and qualifications of your study staff.
  1. Will you have adequate facilities to conduct the study? Please explain and justify.
  1. Will your process ensure that all persons assisting with the research are adequately informed about the protocol and their research related duties and functions? Please describe the training you will provide to meet this requirement.
  1. Will you have medical or psychological resources available that participants might require as a consequence of the research when applicable? Please describe these resources.

PRIVACY AND CONFIDENTIALITY

  1. For minimal risk studies, have you considered waiving the signature requirement since the only

record linking the subjects and the research would be the consent document and the principal risk

would be the potential harm to privacy?...... YES NO

If you decide to do so, please remember that each participant must be asked whether he/she wants documentation linking them with the research, and the participant’s wishes will govern.

(Common Rule 45 CFR 46.117(c))

  1. Please include a description of procedures for protecting the privacy interests of participants. Additionally, are the conditions affecting interaction with the participants and data collection adequate for the protection of privacy (for example, recording physical measurements of pre-teens in a school-setting, eliciting private medical or financial information in a quasi-public setting)?
  1. Do personal identifiers (e.g., names, social security or medical record numbers) need to be recorded for potential participants during screening and recruitment and for actual participants?
  1. Will the private information you will be using be coded or be destroyed at some stage of the research?
  1. Will a code (e.g., number, letter, symbol replacing identifier) afford sufficient protection from deciphering?

For instance, the use of initials or the last 4 digits of the social security number may not offer sufficient

protection.

  1. Please describe the steps you will take to ensure the security of the data or the codes linking information to an individual (including encryption, safe transmittal and storage, protection against loss, theft, or access by unauthorized persons).
  1. For this study, is it feasible to either not collect (e.g., anonymous data) or remove identifiers, substitute a code for identifiers, or separate identifiable portions of data from survey instruments?
  1. How will you dispose of electronic and paper documents containing private information?
  1. How will you educate research staff about (and impress on them) the importance of confidentiality, including being conscious of their communication, both verbally and in writing, in such situations as workplace conversation, insurance billing, lost or misplaced papers, and unsecured electronic documents?
  1. Please describe how you will maintain research records in a secure manner (e.g., locked file cabinet), or use additional and more elaborate security (e.g., statistical techniques, encrypting electronic data) for research involving sensitive information.
  1. Describe the planned procedures for protecting against or minimizing risks, including risks to confidentiality.

INFORMED CONSENT QUESTIONS

  1. Respond to the questions concerning consent and provide more detail for qany question that might raise an issue under the circumstances of your protocol:
  2. Will legally effective informed consent be obtained from the participant or the participant’s legally authorized representative or both? If LAR, is it clear who can serve as a LAR?
  3. Will the circumstances of the consent process provide the prospective participant or their representative sufficient opportunity to consider whether to participate?
  4. Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
  5. Will the information being communicated to the participant or the representative during the consent process exclude any exculpatory language through which the participant or the representative is made to waive or appear to waive the participant’s legal rights, or release or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence (e.g. I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?

MULTI-SITE STUDIES

  1. Is this a multi-site study?...... YES NO

If “yes”:

  1. Are you the lead investigator for this study?...... YES NO
  1. Is Stanford the coordinating site for this study?...... YES NO
  1. If you are the lead investigator for this multi-site study, what is your role in coordinating the participating sites?
  1. Since Stanford is the coordinating site for this study, please describe what procedures are in place for routine communication with the other participating sites. Additionally, please explain how you will document these routine communications with the participating sites (e.g., telephone conferences, planned meetings, email communications, etc.).
  1. Since Stanford is the coordinating site, explain how you will manage the communication of adverse outcomes, unexpected problems involving risk to participants or others, protocol modifications or interim findings.

DSM PLANS

26. If your protocol is more than minimal risk, please include a DSM Plan and explain below. The monitoring plan must be commensurate with the level of risk. See the Guidance on Data Safety and Monitoring Plans at .

CHAIR APPROVAL

27. If your study is unsponsored (no funding, department funding, or gift funding), please request that your Department Chair respond to the following comments regarding your study:

  1. Are the research procedures the least risky procedures that can be performed consistent with sound research design?
  2. Is the research likely to achieve its aims?
  3. Is the proposed research of sufficient scientific importance to justify the risks entailed?
  4. Are there adequate resources (e.g., facilities, qualified staff, access to population that will allow recruitment of the required number of participants)?

Please email responses from the Department Chair to . When the PD is a student, this attestation may be sent by the Faculty Sponsor.

File: APP02004 rev 1/13/06 1 of 4