Local Context Supplement for Multi-Center Studies /
Version 2.0
Updated 4.3.2014 / Research Integrity Office
Mail Code L106-RI
Portland, Oregon 97239-3098
Phone: 503.494.7887
Fax: 503.346.6808
PI Name / eIRB
Study Title
INSTRUCTIONS
Use this form only if you are not allowed to edit the protocol. If these questions are already addressed in the protocol, you do not need to provide duplicate information here. Instead, please refer to the page number(s) where the information is located.
  1. Describe how OHSU investigators will identify and recruit potential study participants. Upload final versions of all recruitment materials (flyers, advertisements, letters, videos, text of radio announcements, etc.)
  1. Will you collect information from subjects or perform any study procedures without first having subjects sign a complete consent form (includes screening procedures, such as telephone screening)?

If yes, describe and provide justification for any alternative consent procedures, e.g. verbal consent (such as for a phone screen or simple survey), information sheet, waiver of consent, abbreviated consent form, etc. Note if different parts of the study will use different consent mechanisms.

  1. Describe the consent process at OHSU, addressing the following items as applicable. Upload all consent documents (consent forms, information sheets, phone scripts, etc.).
  2. Where, when, and how the consent discussion will take place.
  3. The process to ensure ongoing consent.
  4. Any steps that will be taken to minimize the possibility of coercion or undue influence.
  5. Any steps that will be taken to ensure the subjects’ understanding.
  6. If the study involves children, describe your plan for obtaining consent from one or both parents or a legal guardian. Describe whether and how assent will be obtained and documented.
  1. How is the consent discussion conducted with potential subjects who have Limited English Proficiency? (e.g., Will you translate the consent form? Will you use a short form consent? Confirm that a translator will be present for the initial consent process and subsequent study visits.)
  1. If this study involves payment to subjects, describe the amount, method, and timing of payments, including how payments will be prorated for subjects who partially complete the study.
  1. Describe the steps that will be taken to ensure the confidentiality and security of subject information and specimens during storage and use at OHSU and, if applicable, transfer within or outside OHSU (e.g. training of staff, authorization of access, password protection, encryption, physical security, separation of identifiers from data and specimens, certificate of confidentiality). See the Security and Confidentiality Protocol Checklist for more detailed instructions and examples.
  1. Describe any measures taken at OHSU to protect subjects’ privacy during recruitment, consent, and study procedures (e.g. where subjects are being photographed or videotaped, being asked to answer sensitive or personal questions, being asked to disrobe for study procedures, or in other situations that may be perceived as invasive).
  1. Will the conduct of the study at OHSU differ in any way from the protocol? (E.g. not participating in the first phase of the study, conducting additional procedures, not participating in data analysis, etc.) If so, please explain.
  1. If the study involves anonymous or coded genetic research and consent for genetic research will NOT be obtained, describe your plan for checking genetic opt-out status in accordance with the Oregon Genetic Privacy Law. For more information, see the OHSU Research Integrity Office Policy for Accessing Tissue Specimens or Information at OHSU for Anonymous or Coded Genetic Research.

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