Consent Forms & Guides 

Consent Forms 

• Consent Form Checklist designed to ensure you have included all the required elements of informed consent, using appropriate language
• 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
• Sample Consent Forms
  • Clinical Study sample form intended to help investigators construct documents that are as short as possible and written in plain language for clinical studies
  • Non-Clinical Study sample form intended to help investigators construct documents that are as short as possible and written in plain language for non-clinical studies
  • Sample Parental Permission sample form intended to help investigator construct documents that contains all required elements of consent and required institutional language which meets the readability standards for 8th-grade reading level or lower.
  • Sample Child Assent sample form intended for use with children ages ~6-12
  • Sample School Administrator sample form intended to help investigator construct documents that contains all required elements of consent and required institutional language 
  • Sample Consent Script example of a verbal script and accompanying contact information card used to help investigator construct documents to obtain informed consent for participation in an research study
• Physical Activity Readiness Questionnaire (PAR-Q) designed to identify the small number of adults for whom physical activity might be inappropriate or those who should have medical advice concerning the suitable type of activity.
• Certificate of Confidentiality Application Template sample form intended to help investigator construct documents that contains all required elements of consent and required institutional language to certify confidentiality of application
• Motion/Simulator Sickness Screening Form is intended to help investigators mitigate risks of people becoming ill in studies involving simulators, virtual reality, movement, etc.

Guides for Asking Consent

• 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

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 
• 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

Federal Documents for IRB

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

FDA Documents

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