What is the definition of research?

Research using human participants is a systematic investigation that obtains data from or about living people. The investigation is a key part of (a) research projects, (b) research development and related projects, and (c) projects involving testing, evaluation, training, demonstration, and service programs.

When and why do I need to be concerned about research review at GU?

1. If you are not certain about the need for IRB approval, you should discuss your questions with your faculty sponsor, department chair, the AVP's office and/or the Government Relations office (ext. 4064/65).

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/

What kind of projects are reviewed and what standards are used?

GU's Institutional Review Board evaluates both (a) initial (new) proposals for research, and (b) ongoing research projects using human participants. The standard used include the legal requirements and the ethical guidelines that exist for each discipline. For example, research using human participants often involves:

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 their 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.

Why is Informed Consent required from human participants?

The purpose is to insure that human participants (a) are informed of the research process and procedures, (b) are informed of the risks and benefits, and (c) are protected against any possible violation of privacy or confidentiality that could cause harm to themselves or their relatives.

What are the responsibilities of GU's IRB?

1. Education, training, and assistance for faculty, staff, and students who are involved in research.

2. Evaluation of all proposals for initial (new) research, usually within 5-15 calendar 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.

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?

Yes, both you and your collaborators must have your respective institutions - unless (a) the initial IRB review classifies your research proposal as Exempt (free) from continuing reviews each year, and (b) no changes are made to ongoing research that alters the Exempt classification.

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/

How long do I need to hold my research data?

Three years.