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]