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Short Consent Form For Research for the United States

Short Consent Form For Research Template for United States

A Short Consent Form for Research is a legally required document used in the United States to obtain informed consent from research participants. It provides essential information about a research study in a concise, accessible format, complying with federal regulations (45 CFR 46) and IRB requirements. The document outlines the study's purpose, procedures, risks, benefits, and participant rights while ensuring regulatory compliance and participant protection.

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What is a Short Consent Form For Research?

The Short Consent Form for Research is designed to meet U.S. federal requirements for human subject research while maintaining clarity and brevity. It emerged from the need to make research consent more accessible and understandable for participants while still meeting regulatory requirements. This document is particularly useful for minimal-risk studies or when standard consent forms might be too complex or lengthy. It must comply with 45 CFR 46 (Common Rule), institutional IRB requirements, and applicable state laws. The form includes essential elements of informed consent while omitting unnecessary technical details that might overwhelm participants.

What sections should be included in a Short Consent Form For Research?

1. Study Title: Clear, concise title of the research study

2. Principal Investigator Information: Name and contact information of the lead researcher

3. Purpose of Research: Brief explanation of research objectives

4. Study Procedures: What participants will be asked to do

5. Risks and Benefits: Known risks and potential benefits of participation

6. Voluntary Participation: Statement about right to refuse or withdraw

7. Confidentiality: How participant information will be protected

8. Contact Information: Who to contact with questions or concerns

9. Signature Block: Space for participant acknowledgment and date

What sections are optional to include in a Short Consent Form For Research?

1. Compensation: Details about payment or reimbursement for study participation

2. Alternative Procedures: Description of other options available to participants outside of the study

3. Future Use of Information: Explanation of how data may be used in future research studies

4. Audio/Video Recording: Details about recording procedures and participant rights regarding recordings

What schedules should be included in a Short Consent Form For Research?

1. HIPAA Authorization: Additional form for medical information access and privacy protection

2. Study Calendar: Timeline of study visits and procedures

3. Contact Card: Emergency contact information card for study participants

4. Study Summary: Simplified overview of key study information in lay language

Authors

Alex Denne

Head of Growth (Open Source Law) @ Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Jurisdiction

United States

Publisher

Ƶ

Document Type

Consent Form

Cost

Free to use
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Industries

45 CFR 46 (Common Rule): Federal regulation that provides basic requirements and protections for human subjects research, including informed consent requirements, IRB review processes, and additional protections for vulnerable populations

21 CFR 50: FDA regulations specifically governing informed consent in clinical trials and FDA-regulated research

HIPAA Privacy Rule: Federal regulation protecting medical information privacy, crucial when research involves protected health information

IRB Requirements: Institutional Review Board specific requirements for research consent forms, which may vary by institution

The Belmont Report: Foundational ethical principles for human subjects research: respect for persons, beneficence, and justice

Declaration of Helsinki: International ethical guidelines for medical research involving human subjects

ICH-GCP Guidelines: International Conference on Harmonisation - Good Clinical Practice guidelines for clinical research

State Privacy Laws: Specific state-level privacy regulations that may affect research consent requirements

Vulnerable Population Protections: Special additional protections required for research involving vulnerable populations such as children, prisoners, or mentally disabled persons

Language Accessibility Requirements: Regulations requiring consent forms to be provided in appropriate languages and at appropriate reading levels for the target population

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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