IRB Templates

Exempt Information Sheet Template  [+/-]

Also called an “abbreviated consent” form. If the exempt research involves obtaining information through intervention or interaction with subjects, “abbreviated consent” must be obtained using this form. Another common use of this template is if you are doing Expedited or Full Board (non-exempt) research and are requesting an alteration of consent to use a shortened consent form.

Exempt Information Sheet Template (Spanish)  [+/-]

Spanish translation of the Exempt Information Sheet. While the template language is translated, you will still need to ensure that the study-specific language is translated by an appropriate translator. NOTE: The IRB does NOT need to review or approve translations done for Exempt studies.

Parent Permission Exempt Information Sheet  [+/-]

Use this form when you need to obtain abbreviated consent from a parent in order to enroll their child into the research.

Adult Consent Form Template  [+/-]

Use this form with potential adult participants or their Legally Authorized Representative (LAR). This consent form may also be used for minors who can consent for themselves in specific situations (e.g., a pregnant minor who will make decisions for their own pregnancy/baby).

Adult Consent Form Template (Spanish)  [+/-]

Spanish translation of the Adult Consent Form Template. While the template language is translated, you will still need to ensure that the study-specific language is translated by an appropriate translator. Submit to the IRB for approval along with an associated Translator Qualifications Form.

Translator Qualifications Form  [+/-]

Use to demonstrate to the IRB that your translations were done by a qualified individual. If the translation is performed by a third-party vendor, the IRB will accept an attestation/certificate on company letterhead with the name of the document(s) translated and the date.

Parent Permission Form Template  [+/-]

Use this form when you need to obtain parental consent to enroll children into the research. Discuss the process for obtaining child assent in your IRB application, as appropriate.

Parent Consent and Permission Form Template  [+/-]

Use this form when you need to enroll both the parent(s) and the child(ren) into the research. Discuss the process for obtaining child assent in your IRB application, as appropriate.

Consent to Collect Data after Withdrawal Template  [+/-]

Use this form if you’d like to request to collect future health care data collected for clinical care for participants who otherwise withdraw from active participation on a study.

 Adult Authorization Form Template  [+/-]

Only use if consent form lacks HIPAA authorization language (called “Use and Sharing of Your Health Information”). All templates above contain HIPAA Authorization language, but rarely some sponsors or studies prefer to have this in a separate form from the consent form.

Brief Screening Agreement  [+/-]

Use this form if you need to ask eligibility screening questions prior to conducting the full consent process. Do not use this form (use the below “Screening Questions Full Consent Template”) if your screening procedures include clinical procedures (such as a blood draw).

Screening Questions Full Consent Template  [+/-]

Use this form if your screening procedures involve clinical procedures that occur prior to conducting the full consent process.

Opt-Out Recruitment Template  [+/-]

Use this form to create a recruitment opt-out letter or electronic message to send to potential subjects. This recruitment method helps avoid “cold calling” when you need to introduce the study to potential participants with whom you have no prior relationship (i.e., clinical or previous study) and when there is no warm hand-off available from a treating clinician. NOTE: Cold calls are generally not allowed per institutional policy.

Recruitment Script Template  [+/-]

Use this form to demonstrate to the IRB what the study team will say to a participant if meeting them in person or following up a letter with a phone call. While this is a guide, it must not contain inaccurate information and must be consistent with other study materials.

Protocol Template  [+/-]

Use this for studies that require an external protocol IN ADDITION to the INSPIR application. A separate protocol is REQUIRED for all initial submissions of medical or surgical clinical trials, multi-site clinical trials of any type, NIH-funded clinical trials of any type, and for any study that is required to post results on ClinicalTrials.gov.

CAPA Plan Template  [+/-]

Use this when you need to create a corrective and preventative action plan for a major deviation or unanticipated problem. Attach this within the Reportable Event and New Information form submission in INSPIR.

 Single Patient Expanded Access Consent Template  [+/-]

Use this form for individual patient treatment using an investigational device or drug as part of FDA-approved Expanded Access.

Guidance for abbreviated IDE requirements  [+/-]

This guidance document provides instructions for requesting a “nonsignificant risk” determination from the BMC/BUMC IRB in relation to the use of an investigational device.

Guidance for Individual Patient IND and Emergency Use  [+/-]

This guidance document provides detailed step by step instructions on obtaining FDA and BMC/BUMC IRB approval for use of investigational drug(s) with an individual patient.