51漫画

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

GDPR Consent

For information about the European Union General Data Protection Regulation (鈥淓U GDPR鈥�), visit our GDPR Consent Guide page.   

Research Information

• 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 
• 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
• the purpose of this policy is to ensure that the health needs of the mother and the fetus

Federal Documents for IRB

Applies to IRB-regulated studies

• this report identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with 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
• 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)
• Information For Covered Entities And Researchers On Authorizations For Research Uses Or Disclosures Of Protected Health Information
• guidance to provide additional protection for the children who would be involved in the research

FDA Documents

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

• guidance documents represent the Agency's current thinking on the conduct of clinical trials/good clinical practice and human subject protection
• priorities set for the development of good clinical practice and human subject protection 
• primary purpose of this chapter is to inform the public of the nature and uses of Federal Register publications