Consent Forms & Guides

A collection of informed consent, assent, and debriefing templates that can be used for your human participant research study.

Consent Form Guides

Consent Form Checklist designed to ensure you have included all the required elements of informed consent, using appropriate language
Informed Consent used to document the information provided to a subject to gain his/her agreement to participate in a study.
Assent for Minors Federal regulations require a number of special protections for minors (in Louisiana, persons under the age of 18).
Consent Script used to document the information provided regarding the research being conducted.
Consent for Mail & Telephone Surveys used to document the information provided to a subject to gain his/her agreement to participate in a study either by mail or telephone
LSU GDPR Consent for Participants Data Subject for the Collection and Processing of Personal Data from the European Union
LSU GDPR Consent for Co-Investigators Co-Investigator Consent for the Collection and Processing of Personal Data from the European Union

For information about the European Union General Data Protection Regulation (“EU GDPR”), visit our GDPR Consent Guide page.

Use of Human Subjects: Basic Requirements & Procedures used to document information to determine if the research is considered human subjects and compliance with regulations at all phases of application and award
Research with Cognitively Impaired Persons the purpose of this policy is to outline the additional protections that investigators and the IRB should consider when proposed research projects involve adults who are cognitively impaired
Rules Concerning Use of Pregnant Women in Research the purpose of this policy is to ensure that the health needs of the mother and the fetus

Applies to IRB-regulated studies

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research this report identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects
Title 45 Code Of Federal Regulations Part 46 - Protection of Human Subjects this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research
Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well-being of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS)
HIPAA Authorization for Research Information For Covered Entities And Researchers On Authorizations For Research Uses Or Disclosures Of Protected Health Information
Additional ED Protections for Children guidance to provide additional protection for the children who would be involved in the research

Applies to studies that use FDA-regulated drugs, devices, or clinical studies

Regulations for Clinical Studies- Studies that use FDA approved drugs guidance documents represent the Agency's current thinking on the conduct of clinical trials/good clinical practice and human subject protection
FDA Regulations 21CFR 50.24 priorities set for the development of good clinical practice and human subject protection
Code of Federal Regulations (searchable - via GPO) primary purpose of this chapter is to inform the public of the nature and uses of Federal Register publications