Georgetown University - IRB




				Office of Regulatory Affairs INSTITUTIONAL REVIEW BOARD (IRB)

	IRB Home MedStar Research Institute-Georgetown University Oncology IRB Social & Behavioral IRB IRB Board Members Contact Info Calendar of meetings IRB Forms IRB Manuals Human Subject Protection Training Report Research Compliance Complaint or Concern			Overview of Research with Human Subjects in the Social and Behavioral Sciences In deciding what must be reviewed, what type of review is appropriate, and who will conduct the review, there are a number of questions to be asked: Does the project meet the definition of research with human subjects? Is the research conducted by or under the direction of a Georgetown employee (faculty, student, or administrator) even if it does not take place at Georgetown University? Is the subject population vulnerable in any way and are regulations in place to protect that population? Does the research involve deception? What is the level of risk? Does the research activity fit into one of the categories of research that can be screened for exemption or into one of the categories of research that can be reviewed using expedited procedures? Who does the review and when? Does the project meet the definition of research with human subjects? The definition of research with human subjects is as follows: "Research means a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge."A human subject is a living individual about whom an investigator, (whether professional or student) obtains data through an interaction with the individual or obtains identifiable private information. The intention to contribute to such knowledge is key to the definition, whether or not the completed research does make such a contribution or is accepted for publication. All of the following activities may be included in the definition: Pilot studies (research development) Interview procedures Surveys Observation Case studies Oral histories Analysis of existing data Is the research conducted by or under the direction of a Georgetown University employee (faculty, student, or administrator) even if it does not take place at Georgetown University? According to Georgetown's policies, such research must be reviewed by the IRB-c in advance of any involvement of human subjects. This includes research conducted at another institution in this country or research conducted abroad. It includes collaboration with investigators at other institutions, and it includes research in which other institutions or researchers gather the data for a Georgetown researcher. (The type of review for such projects is not limited. They may be determined to be exempt if the eligibility criteria are met.) Is the subject population vulnerable in any way and are regulations in place to protect that population? There are several categories of protected subjects. Children - Subpart D of the federal regulations protecting human subjects, incorporated in Georgetown's policies, provides additional protections for children. Research with children as subjects can be exempt in only two instances: Observational studies in which the investigator does not interact with the subject, and Research conducted in established or commonly accepted educational settings involving normal educational practices. Prisoners - Subpart C to the governing regulations provides additional safeguards for prisoners as research subjects. Essentially, the regulations are designed to discourage the use of prisoners as subjects unless the research will materially affect the lives of prisoners. They are not, in other words, to be used as a captive population. An IRB that reviews a protocol with prisoners as subjects must have a prisoner representative on the committee. Georgetown Students and Employees - The Georgetown policy on students and employees is designed to address the possibility of coercion, even unintended or unwitting coercion. Other than with respect to research that is exempt, if instructors wish to use students in their own classes, or if Georgetown employers wish to use their own employees in research involvinghuman subjects, full committee review is ordinarily required. All members of the Georgetown community are cautioned to use particular care in considering methods of subject selection or recruitment involving one's own students or employees. Does the research involve deception? All research involving deception of subjects must be reviewed by the full IRB-c. What is the level of risk? Much of the research in the social and behavioral sciences has no more than minimal risk. The greatest risk is often a breach of confidentiality, when such a breach could result in social stigma, loss of employment, legal prosecution, embarrassment, damaged family relationships, and sometimes physical danger. Research asking subjects to relive or reveal violence perpetrated against them, such as sexual assault, may also carry emotional risks. The degree of risk must be no more than minimal in order for research to be determined to be exempt or considered eligible for expedited review. Does the research activity fit into one of the categories of research that can be screened for exemption or into one of the categories of research that can be reviewed using expedited procedures? Research activities which may be determined to be exempt, provided there is no more than minimal risk, are listed in our IRB-c Manual and on our website. Activities eligible for expedited review, provided there is no more than minimal risk can be found in the IRB-c Manual and on our website. Who Does the Review? And When? Applications for determination of exemption may be submitted at any time for review and approval by the IRB-c Committee or the authorized person in the investigator's department or school. Review may be completed within two or three days. Requests for expedited review may be submitted at any time for review by the Chair of the IRB-c or a designee. The timing of the review depends upon the schedules of available reviewers. Requests for full review must be submitted in accordance with the posted submission deadline schedule. These upcoming dates are shown on the website at Change URL Last revised: November 13, 2001			IRB-C Quick Links: IRB-C Main Page Overview of Research with Human Subjects in the Social and Behavioral Sciences Exempt Research Expedited Approval of Research IRB-C Investigator's Manual IRB-C Forms IRB-C Members IRB-C Meetings Office of Compliance and Ethics