Frequently Asked Questions
1 . What is the definition of research?^
2 . When and why do I need to be concerned about research review at GU?^
2. Before starting a project at GU, all proposed research using human participants must be evaluated and approved by the Institutional Review Board (IRB). In addition, some classifications of ongoing research are reviewed annually or when certain changes are made to the research's scope or activities. The University requires that all research be conducted within the highest possible legal requirements and ethical principles.
3. Legal requirements to protect human participants apply to a much broader range of research than you may realize. Often, additional ethical standards are applied in many disciplines.
4. Faculty, staff, or students conducting human participants research, or involved as key personnel in a research or training project, may complete an online educational tutorial. This tutorial is accessed through the National Institutes of Health, Office of Human Subjects Research website: http://ohsr.od.nih.gov/
3 . What kind of projects are reviewed and what standards are used?^
Private information, such as survey responses, educational records, medical information, etc., that can be identified with an individual - even if the information was not specifically collected for your research;
Legal permission from adults, minors, and children, such as the need for Informed Consent, the kind(s) of consent needed, and the manner of obtaining consent;
Safeguards, such as plans that must be put into place for protecting the confidentiality of the participants and tier relatives;
Materials, such as cells, blood, urine, tissues, organs, hair or nail clippings, etc. - even if you did not directly collect these materials; and audio and videotape materials.
4 . Why is Informed Consent required from human participants?^
5 . What are the responsibilities of GU's IRB?^
2. Evaluation of all proposals for initial (new) research, usually within 5-15 calender days.
3. Classification of all approved research proposals through one of these processes:
4. Continuing Reviews of ongoing research held (a) annually, or (b) when changes are made to a project that may result in a different classification.
6 . If I obtain all the data from collaborators, do I need to obtain IRB review of my initial research proposal and reviews of ongoing research?^
7 . Where on the Internet can I find help and additional information about researching human participants?^
(Federal) Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/ The Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
NHGRI Ethical and Social Issues Program http://www.nhgri.nih.gov/ELSI/
(Federal) Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/
The Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
8 . How long do I need to hold my research data?^