Resources

Other Resources From the Department of Health and Human Services

Researchers and institutional review board (IRB) officials will also find these resources from the Department of Health and Human Services helpful.

Creating Easy-To-Read Informed Consent Documents

Clear & Simple: Developing Effective Print Materials for Low-Literate Readers
http://www.cancer.gov/cancerinformation/clearandsimple
National Cancer Institute

Simplification of Informed Consent: Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials
http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/page2
National Cancer Institute

Simply Put: Tips for Creating Easy-To-Read Print Materials That Your Audience Will Want To Read and Use (includes a description of the Fry Readability Scale)
http://www.cdc.gov/od/oc/simpput.pdf (PDF File, 2.7 MB; PDF Help)
Centers for Disease Control and Prevention

Consent for CDC Research: A Reference for Developing Consent Forms and Oral Scripts (includes a description of the SMOG Readability Formula)
http://casr.ou.edu/hiv/consent_letters.pdf (PDF File, 840 KB; PDF Help)
Centers for Disease Control and Prevention

Translation
Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm
Office for Human Research Protections

Health Insurance Portability and Accountability Act (HIPAA) Guidance
Health Services Research and the HIPAA Privacy Rule
http://privacyruleandresearch.nih.gov/pdf/HealthServicesResearchHIPAAPrivacyRule.pdf (PDF File, 208 KB; PDF Help)
National Institutes of Health

Office of Civil Rights—Research Guidelines on HIPAA Privacy Rules
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/research.html

Informed Consent Guidance
Informed Consent Checklist
http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm
Office for Human Research Protections

Tips on Informed Consent
http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm
Office for Human Research Protections

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