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U.S. Department of Health and Health Services www.hhs.gov
Office of Disease Prevention and Health Promotion
Health Literacy Online: A Guide to Writing and Designing Easy-to-Use Health Web Sites
Appendix C: Sample Testing Documents

INFORMED CONSENT

The Agency for Healthcare Research and Quality (AHRQ) has developed an Informed Consent and Authorization Toolkit for Minimal Risk Research to facilitate the process of obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from potential research participants.

The AHRQ toolkit includes a sample Informed Consent Form written in plain language. The sample form can be accessed at http://www.ahrq.gov/fund/informedconsent/icform1.htm.

SAMPLE SCREENER

Our desired participants are women, with a mix of age and other characteristics, who have some (but limited) experience using the Internet.

Age: People aged 18 and older

Gender: Mostly female

Education: High school equivalent or less

Ethnicity: An ethnically mixed group if possible

Income: Household income of $40,000 or less

We will exclude from participation users who:

  • Have participated in a usability test or focus group within the past year.
  • Conduct market research or design and develop Web sites.
  • Are unable to speak or read English enough to complete the study.
  • Have actively looked for health information on the Internet in the last year.
  • Are everyday users of the Internet.
  • Are unable to use a computer.

Hello,

This is NAME from COMPANY. We are doing a research study on a health Web site. If you qualify, we will pay you $75 to participate in a 1-hour meeting at LOCATION. This is a research study. We are not selling anything. Other people who have participated have found it to be interesting and fun. Does it sound like something you would be interested in?

Great. Let's find out if you qualify. I have a few simple questions to ask. This should only take a few minutes. At some point, I may end the questions if I discover you don't qualify. This has nothing to do with you. We simply are looking for people who meet certain criteria.

[Insert standard questions about participation in market research…]

How often do you use the Internet?

___   Every day [REJECT]

___   A few times per week [CONTINUE]

___   About once per week [CONTINUE]

___   Less than once per week [CONTINUE]

___   Never or hardly ever [REJECT]

Over the past year, have you looked for information on the Internet about a health problem that you or someone you knew had?

___   Have done this often [REJECT]

___   From time to time [Include only a few in this category]

___   Hardly ever [CONTINUE]

___   No [CONTINUE]

[Insert standard demographic questions…]

In this study, you will be asked to try out a Web site. This is not a group study; you will meet one-on-one with a researcher. You will be recorded on both audio and video. Are you comfortable with this?

___   Yes [CONTINUE]

___   No [REJECT]

In this research study, we will be asking you questions about how you use the Internet, and we will ask you to try out some Web sites. It will take about 1 hour. When you're done, we will pay you $75. We really appreciate your help. I have the following times available.

[Insert standard questions about scheduling]

[End]

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