Human Subjects (IRB) - Subject Rights and Information for Research Participants

  Contact about Subject Rights
  Information for Research Participants
  Become a Volunteer
					

Contact about Rights of Research Participants

If you have any questions about the rights of research participants or a research-related injury, please contact the IRB Administrator, 1138 Pearson Hall, (515) 294-4566; irb@iastate.edu or the Office of Research Assurances Director Diane Ament, Vice President for Research and Economic Development Office, 1138 Pearson Hall, (515) 294-3115; dament@iastate.edu.

Information for Research Participants

Iowa State University is committed to protecting the health, safety and rights of participants in research projects. The federal code that Iowa State University must follow is 45 CFR 46 Protection of Human Subjects. Within that law, there are rules that apply not only to what the participant should be told about a study, but also how a participant should be given the information. Participants are to be given sufficient time to decide if they would like to participate and should not be coerced. In addition, the information presented to participants must be in a language understandable to them or their representative. No informed consent, whether oral or written, can require that a participant waive or appear to waive any of their legal rights, or release or appear to release the investigator or institution of their liability for negligence. Therefore, informed consent is more than the signed document; it is the communication process that helps volunteers learn about a study and allows them to make an enhanced decision about participating. It is an ongoing process that begins before enrollment in the study and continues through the completion of the study and sometimes through follow-up. The process and the subject’s willingness to participate is documented by the participant’s signature, along with the date that they agreed to participate, on the informed consent document. The participant is required to date the document and the consent is not valid if dated by anyone else. All participants are to receive a copy of the informed consent document that they signed. Before someone agrees to participate in a study, they should make sure that they know the following about the research study.

CFR Title 45, Part 46.116, Sub-part A

In seeking informed consent, the following information shall be provided to each subject:

1. a statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. a description of any reasonably foreseeable risks or discomforts to the subject;
3. a description of any benefits to the subject or to others which may reasonably be expected from the research;
4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
8. a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

The law also requires that, when appropriate, one or more of six additional elements of information be given to volunteers. More information about the additional elements and the rights of human subjects may be obtained at the following link. http://ohrp.osophs.dhhs.gov/humanSubjects/guidance/45cfr46.htm

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Becoming a volunteer

For information about becoming a volunteer, please follow the link.
http://www.hhs.gov/ohrp/outreach/documents/3panelfinal.pdf

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