Study Participant Protections




“When I think of research, I think of my family, my village. I think sometimes we don’t pay attention to what is being done to us” ~Lisa Dolchok, Tribal Doctor, Traditional Healing




All researchers must follow federal and state laws about research.These laws were created because of research in the past that caused people harm.The Belmont Report and Common Rule are two important documents that protect people in research.



Study Participant Protections


This is a national report that guides how researchers work with people participating in research.  It has three main principles, including:


  1. Respect for Persons: to respect a person’s right to privacy and free will
  2. Beneficence: to do as much good and as little bad as possible
  3. Justice: to make sure all people are treated equally

For more information about the Belmont Report, visit:
Office of Human Research Protection - http://www.hhs.gov/ohrp/



Common Rule


This rule was issued by the United States government and makes sure research is reviewed properly to protect human participants.It has rules about the following:


-What research must be reviewed
-Who must conduct the review
-What questions should be answered during the review
-What kind of review should happen during the entire research project


The common rule guides one very important part of the review process at Southcentral Foundation, the review by the Alaska Area Institutional Review Board.



Alaska Area Institutional Review Board


The Alaska Area Institutional Review Board oversees health research in Alaska that involves Alaska Native people.It makes sure Alaska Native people are treated with resepect, are kept safe, and that the community is protected.It can help all tribal health corporations with technical questions they may have about research. One thing this board looks at is whether informed consent is being given when required by law.To learn more about institutional review boards, visit:


http://www.fda.gov/oc/ohrt/irbs/faqs.html


Informed Consent Process


Informed consent is a way for a researcher to share information with someone interested in joining a research study.The following topics are covered in informed consent.


  • Why the study is being done
  • What you will be asked to do in the study
  • Who is doing the study.
  • What you might gain or lose by joining the study.


Participant Rights


When someone chooses to join a study, they have rights as a study participant. These include the right to:


  • Not take part in any part of the research study.
  • Withdraw at anytime.
  • Receive new information about the study.
  • Ask questions at any time to the research staff and have them answered as soon as possible.

Study participants should stay informed about the study once they have joined.


This means asking questions about anything not understood.