Sorry, you need to enable JavaScript to visit this website.

Sign Up For Mailing List Button

Donate to Genetic Alliance

Disease Search Button

Chapter III - Purpose of the Genetic Alliance Institutional Review Board

Facebook icon
Google+ icon
Twitter icon
LinkedIn icon
Del.icio.us icon
Digg icon

The primary purpose of the Genetic Alliance IRB is to protect the rights and welfare of human participants involved in research activities being conducted under its authority. In so doing, the IRB shall ensure adherence to the criteria for IRB approval as listed in 45 CFR 46.111 and 21 CFR 56.111 i.e., that:

  • The risks to human research participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose the research participants to risk, and whenever appropriate, by using procedures already being performed on participants for diagnosis or treatment purposes;
  • The risks to human research participants are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result;
    • For IRB consideration, "benefit" is defined as a valued or desired outcome; an advantage;
    • For IRB consideration, "risk" is defined as the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study;
    • In evaluating risk, the IRB is to consider the conditions that make the situation dangerous, per se (i.e., as opposed to those chances that specific individuals are willing to undertake for some desired goals). 
    • In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (i.e., as distinguished from risks and benefits of treatments or procedures that the patient would undergo if not participating in the research);
    • In evaluating risks and benefits, the IRB does not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of research on public policy).
  • The selection of human participants for research participation is equitable;
  • Human research participants are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent is obtained from each prospective human research participant, or his/her legally authorized representative, in accordance with, and to the extent required by federal regulations and IRB policies;
  • Informed consent of human research participants is obtained in advance of research participation and appropriately documented in accordance with, and to the extent required by federal regulations and IRB policies;
  • The research plan, when appropriate, makes adequate provisions for monitoring the data collected to ensure the safety of human research participants;
  • There are adequate provisions to protect the privacy of human research participants and to maintain the confidentiality of research data;
  • Appropriate additional safeguards have been included in the study to protect the rights and welfare of human research participants who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, decisionally impaired persons, or economically or educationally disadvantaged persons).
Twitter icon
Facebook icon
LinkedIn icon
Google+ icon
YouTube icon
RSS icon

4301 Connecticut Ave NW, Suite 404, Washington DC 20008-2369 | Tel: 202.966.5557 | Fax: 202.966.8553 | EIN 52-1571905

Except where otherwise noted, content on this site is licensed under a Creative Commons Attribution 3.0 License.