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Researcher Toolkit

The Researcher Toolkit is a library of resources, guidance, and templates for researchers, coordinators, and research staff who are involved with the development of research protocols and submissions to the IRB. All individuals who are involved in the conduct of research involving human participants are encouraged to review the information and templates below that may pertain to your studies. 

If you are unable to find information or resources related to a specific topic, please contact the IRB Office at 405-271-2045 or email to irb@ouhsc.edu. 


TOOLKIT SECTIONS:

IRB Guidance & Resources

Getting Started

Overview of key requirements and the process for submitting a new study to the IRB. 

Policies

Standard operating polices and procedures (SOPs) for HRPP & IRB.

EFIC

OUHSC process for EFIC and planned emergency research.
 

Single IRB

Overview of the processes for reliance agreements and single IRB review.

Quality Improvement (QI) Program

Learn about the QI Program, evaluation process, and resources.

QI Projects vs. Research

New guidance to distinguish between research and non-research activities.

VA Research

VA research requirements, handbooks, and local R&D committee resources.

Survey Research

New guidance for submitting materials to the IRB for approval of survey research.

ClinicalTrials.gov

Learn about OUHSC-specific reporting requirements and request user accounts.

iRIS

Training and resources for using iRIS and how to request accounts.
 

Writing Consent Forms

Access to resources including: dictionaries, glossaries, and reading level calculators.

DoD Research

DoD-supported research policies and requirements.
 

Certificate of Confidentiality (CoC)

Overview of CoC requirements and resources.

Training and Education

Access to training requirements and additional education opportunities.

Document Templates

Protocol

Protocol Outline - 03.12.2019

Consent Templates

HIPAA Form Templates

Paraphrased Form Names

HIPAA Authorization Form 1, 08/20/2024 - Standard Research Privacy Authorization Form

HIPAA Authorization Form 2, 08/20/2024 - Research Authorization for Psychotherapy Notes

HIPAA Authorization Form 3, 08/20/2024 - Authorization for Repository Research

HIPAA Authorization Form 4, 08/20/2024 - Authorization for Research Study that Includes a Repository

HIPAA Form 5, 08/20/2024 - Request for Waiver of Authorization

HIPAA Form 8, 01/06/2016 - Verification for Research on De-Identified PHI

HIPAA Form 9, 01/06/2016 - Verification for Limited Data Sets

HIPAA Form 10, 01/06/2016 - Data Use Agreement (DUA) for Limited Data Sets

*HIPAA Form 6 - Prep to Research and HIPAA Form 7 - Decedent PHI are available electronically in iRIS and accessed via the HSC IRB Application.

VA HIPAA Form 10-0493 - Authorization for Use & Release of Individually Identifiable Health Information for VHA Research

Tracking / Summary Report Templates

Protocol Deviation Summary Report

Summary of Participant Harms Report

Modification Summary Report

Spanish / Translated Documents

Note: The short form consents in Spanish and English are available with the other consent form templates. 

Translator Attestation Statement (sample) - required for all translated documents

HIPAA Authorization Form 1 - Spanish - 08.20.2024

HIPAA Authorization Form 2 - Spanish - 08.20.2024

HIPAA Authorization Form 3 - Spanish - 08.20.2024

HIPAA Authorization Form 4 - Spanish - 08.20.2024

Ancillary Committees & University Research Resources

Links are provided below to ancillary committees and University offices and departments who provide research-related services and information.