Survey Consent Form Template for the United States

Yes, survey consent forms are legally required under The Common Rule (45 CFR 46) for research involving human subjects conducted by federally funded institutions or organizations. Even non-federally funded research typically requires informed consent to comply with ethical standards and institutional review board (IRB) requirements. Failure to obtain proper consent can result in research being deemed invalid and potential legal liability.

Generally no - conducting research without proper informed consent violates federal regulations and can expose you to legal liability. However, IRBs may approve waiver of documentation of consent for minimal risk research where signed forms would be the only record linking subjects to the research. Anonymous surveys with minimal risk may qualify for expedited review or exemption, but you still need IRB approval.

Under federal regulations, you must retain consent documents for at least three years after completion of the research. Some institutions require longer retention periods, and research involving FDA-regulated products may require retention for two years after FDA approval. Always check with your institution's IRB and records retention policies, as requirements can vary based on funding source and research type.

IRB approval must come before you can use any consent form or begin data collection. The IRB reviews and approves your consent form as part of the overall research protocol review process. You cannot legally collect data, even with a consent form, until you receive IRB approval. The consent form is a required component of your IRB application, not a substitute for it.

IRB review timelines vary by institution and research complexity, typically ranging from 2-8 weeks. Expedited review for minimal risk research may take 1-3 weeks, while full board review can take 4-8 weeks or longer. Plan ahead as IRBs often have monthly meeting schedules, and you may need to revise your consent form based on their feedback before final approval.

The most common mistakes include using overly complex language above 8th grade reading level, failing to include required elements like risks and benefits, not providing researcher contact information, and using coercive language. Other issues include inadequate explanation of data confidentiality, missing voluntary participation statements, and failing to update forms when research procedures change during the study.

You need both when your research involves protected health information (PHI) from healthcare providers or health plans. A standard survey consent form covers general research participation, while HIPAA authorization specifically covers the use and disclosure of health information. If you're only collecting health information directly from participants through surveys (not accessing medical records), you typically only need the research consent form.