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In today's world, certain reasonable expectations exist for protection of subjects who participate in human research. These expectations are what most of us would consider to be the right things to do. They include, amongst other truths, dignity for, disclosure to, and decision by subjects regarding participation. To consent requires to know and to know requires prior preparation by subjects in order not to be dependent on presumptions. Existing protections are neither always sufficient nor necessarily administered adequately prior to deciding about consent. The getresearchsmart.org (GRSSM) website offers information and opportunities to more effectively and confidently decide about participation in research.
Here are some questions to ask yourself before participation in human research:
- What's really motivating me to consider participation?
- What are the real risks and real benefits to me from the research offer?
- How does my motivation compare with the offer?
- Is there a mismatch? If so, rethink the offer.
- If not, are the real risks worth it to me?
- What can I do to find out about or clarify crucial facts?
- A - Assume nothing (think in terms of self-protection, not blind trust)
- S - Speak up (question the investigator and consult with others), such as:
- Family
- Friends and significant others
- Doctors not connected to the research (if a clinical study)
- Others (persons with needed expertise or experience)
- K - Know - then decide (e.g., ask about prior review by a research ethics board, confidentiality of my private information, investigator conflicts of interest, and availability of compensation to me if an injury result from participation).
- What institutional and GRS website resources may exist to help me through my decision?
- Ask the investigator if his or her research institution has a subject advocate (sometimes called an ombudsperson) who is not connected with the research offering. If so, that person may be able to help.
- Try the self-help tools of the GRS website:
- Review the QuickTips, GRS Code, and Checklist
- Consult the Decision Flowchart and elective Investigator Declaration
Search the GRS site for topical information and review Q&As
- Explore links to additional resources
- What publicly accessible government information exists by link from the GRS site?
- Which institutions have assured compliance with federal requirements?
- Which independent or institutional review boards (IRBs) have federally registered?
- What other sources of government information exist on research and protections?
| Click here for the basics. |
(10-05-06)
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