Forms/Templates Archive - 91̽��Research

*IRB Protocol

mth13 — Fri, 17 Feb 2017 23:43:44 +0000

This form is used in conjunction with Zipline to submit an application to the IRB. If you anticipate that you will have no contact with subjects, such as with a medical records review, use the form: APPLICATION IRB Protocol, No Contact with Subjects.

The form must be submitted as a Word document (not PDF or other format).

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*IRB Protocol, No Contact with Subjects

mth13 — Fri, 17 Feb 2017 23:45:36 +0000

This form is used in conjunction with Zipline to submit an application to the IRB. Use the No Contact form only if you will have no interaction of any kind (in person, email, internet, social media, etc.) with your subjects.

Use the APPLICATION IRB Protocol if you will interact with subjects, such as with a web based-survey, telephone interview, focus groups, blood draw, etc.

The form must be submitted as a Word document (not PDF or other format).

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*No Separate Key Information Consent Template (2,000 words or less)

mth13 — Thu, 01 Jun 2023 15:57:27 +0000

Use this template for uncomplicated studies, studies with fewer procedures, minimal risks, and/or studies that require 2,000 words or less to explain. The 91̽��IRB considers these shorter consent forms to be concise and focused enough that they don’t require a distinct Key Information section.

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*Report of New Information (RNI) Supplement

mth13 — Sat, 18 Feb 2017 00:29:10 +0000

Use this form in conjunction with Zipline to provide additional information about research-related problems or events to the Human Subjects Division (HSD) for review.

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*Request External IRB Review

Jenny Maki — Sat, 18 Feb 2017 00:00:09 +0000

Use this form to request authorization to obtain IRB review from a non- 91̽��(“external”) IRB instead of the 91̽��IRB.

The form must be submitted as a Word document (not PDF or other format).

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*Separate Key Information Consent Template (more than 2,000 words)

mth13 — Thu, 01 Jun 2023 15:54:32 +0000

This template should be used for studies that are required to have a distinct Key Information section at the beginning of the form per 91̽��IRB policy.

This template is appropriate for complicated, higher risk studies that require the consent form to be more than 2,000 words in order to explain that complexity.

The separate Key Information section helps prospective participants focus up-front on the information that is most likely to influence their decision. The rest of the form fills in additional details and provides other information that may be of interest and/or is required by the regulations.

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*Site Application (Contact)

Jenny Maki — Thu, 31 Mar 2022 14:52:13 +0000

Use this form to describe study-specific information for non- 91̽��sites that are being reviewed by the 91̽��IRB. Use this form if the site involvement in the research involves direct contact with human subjects (e.g., recruitment, consent, data collection, intervention administration, other interactions).

If there will be no contact (e.g., site is only receiving funding or using secondary data or biospecimens) use this form: SUPPLEMENT Site Application (No Contact).

The form must be submitted as a Word document (not PDF or other format).

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*Site Application (No Contact)

Jenny Maki — Thu, 31 Mar 2022 14:54:54 +0000

Use this form to describe study-specific information for non- 91̽��sites that are being reviewed by the 91̽��IRB. Use this form if the site involvement in the research does not involve direct contact with human subjects (e.g., site is only receiving funding or using secondary data or biospecimens).

If there will be contact (e.g., recruitment, consent, data collection, intervention administration, other interactions) use this form: SUPPLEMENT Site Application (Contact).

The form must be submitted as a Word document (not PDF or other format).

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*Status Report, Renew or Close Request

mth13 — Fri, 17 Feb 2017 23:50:09 +0000

Use this form in conjunction with Zipline to renew or close a study.

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Approved User Assurance – NIH Controlled Access Genomic Data

Mara — Thu, 20 Feb 2025 01:49:31 +0000

Attach to the following to your SAGE Item and route to OSP for next steps:

this signed assurance form
a copy of your Data Access Request
confirmation from IT Director

Review more on:

How to Request Datasets from dbGaP
- Preparing your SAGE Item for routing to OSP
91̽��IT:

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