GHC Sites > Stephanie Wright > Human Subjects Research

Human Subjects Research

GHC Office of Planning, Assessment, Accreditation, and Research | GHC Human Subjects Research Policy  | IRB Forms

 

Georgia Highlands College (GHC) maintains an Institutional Review Board (IRB) with the charge of protecting the rights and welfare of humans who participate in research. All activities related to human subjects research must initially be reviewed and approved or exempted by the Georgia Highlands College IRB whether they are conducted by faculty, staff, assistants, students, or any external researcher or collaborator.

 

Use our interactive IRB determination tool below to determine if your study will require IRB review. This tool may be used in place of the IRB Determination Form.

 

Create your own user feedback survey
To conduct human subjects research in which Georgia Highlands College is a participant, follow these steps:

 

 

    • For external researchers: When familiar with GHC’s policy, Take the CITI Human Subjects Research Training Course or the NIH training course. You must successfully complete one of these appropriate training courses to conduct human subjects research at GHC. For the CITI course, enter Massechussets Institute of Technology as your affiliate institution, and select the appropriate course for your study needs. NOTE: for most, this will be social and behavioral sciences, but some may require biomedical or coded specimens courses. After you have read GHC’s policy and completed the training course, prepare your IRB protocol using the form and guidelines provided below and submit it to Dr. Stephanie Wright, IRB Chair, at stwright@highlands.edu. Please use this e-mail for any and all correspondences regarding the IRB.

 

  • For internal researchers: After you have read GHC’s policy and completed the training course, prepare your IRB protocol using the form and guidelines provided below and submit it to Dr. Stephanie Wright, IRB Chair, at stwright@highlands.edu. Please use this e-mail for any and all correspondences regarding the IRB.

 

IRB Forms

 

Georgia Highlands College Policies, Procedures, and Guidelines

 

Federal Regulations and Guidelines
Terms of Georgia Highlands College’s Federalwide Assurance with DHHS OHRP (in process)

 

Additional Resources

 

Why is review necessary?

Review protects people from being subjected to scrutiny, measurements, procedures, or other interventions that violate their basic human rights or otherwise put them at unacceptable risk. Review also protects you, the researcher, and Georgia Highlands College from repercussions of placing subjects at risk. Finally, in an atmosphere of increasing public concern about research with human subjects, review protects the very existence and viability of such research. Review assures the public (from whom study populations are recruited) that the study they are about to participate in has been overseen by the institution supporting the research, in accordance with recognized ethical principles. Research that has not undergone review will be refused funding from public sources.

 

How does GHC comply with requirements for review?
The federal government sets forth procedures, guidelines and practices to be followed by institutions receiving federal research support. In most cases, for the reasons outlined above, institutions follow these guidelines and practices for research with human subjects whether or not federal funding is involved. Each institution is responsible for appointing members to and maintaining the records of an Institutional Review Board (IRB) and for maintaining an official Assurance of Compliance on record with the Department of Health and Human Services (in process). For most institutions of GHC’s research make-up, this means providing a link to an online course, making training materials available and generally providing guidance on regulations.

 

What does review involve?
GHC’s IRB meets virtually as needed. Faculty members or students wishing to conduct research with human subjects complete an application (research protocol) which describes the project in full, in terms understandable to lay readers (that is, all abbreviations are spelled out in full, non-specialist language is used, etc.). The IRB Chair can give guidance on appropriate language. The protocol is submitted to the IRB Chair at least two weeks in advance of the proposed project start date. The members meet, discuss questions they may have, and vote on approval, non-approval, or approval-pending-resubmission of the protocol. The IRB Chair then forwards a decision memo notifying the researcher of next steps, if any are needed.

 

What research should be reviewed?
“Research” means any data collection through any means (surveys, performance on tests, observation and the like), which is used to make generalizable statements (generally speaking, this means that the data or results are published, in any form, via the world wide web, poster presentation, or scholarly paper). It also refers to data, the source of which can be identified. In other words, if you collect names, birth dates, student ID numbers or any other identifying information that could allow you to trace the data back to their source, you are conducting research that will need review at least on some level. Research involving certain degrees of risk (information collected might damage economic status or employability, for example) to subjects also requires review.

 

What research does not need review?
To ensure adequate oversight of research with human subjects, you should not make this call yourself; consult the IRB Chair, who can make a determination for the institution. Generally, “research” does not refer to data gathering in order to improve teaching or education-related practices limited to your own class or project. It also does not refer to market research, the sole purpose of which is to improve a specific process or product (unless, of course, that research will be made public). Studies of public officials or behavior observable in everyday public life is also exempt, if no identifiers are used.

 

Are there any special cases?
Research conducted on students, except to improve your own teaching, is in a category of its own. Surveys or questionnaires administered to GHC students must be approved by the Vice President for Student Affairs, and, if identifiers are used, by the IRB.

 

What does this mean in practice?
Here are some examples. These examples do not cover every case. If you are unsure about any aspect of review, please contact the IRB Chair.

 

Professor Teachwell does research on his class:
Professor I. Teachwell wants to find out if his class is understanding the material he taught them last week. He administers a quiz. This is collection of data to improve his own teaching, and it will not need full review. Professor Teachwell can proceed with the quiz, collect and analyze the results. The following term, Professor Teachwell decides he’d like to use this (now archival) test data and he’d like to gather fresh data from his new class for comparison purposes, because he’d like to publish a paper on the technique he used to teach the first class. He can use the archival data without seeking full review; however, he needs to submit a protocol to full review to administer the test to the new class.

 

Sophomore student does research on her dorm mates:
Claire Hyde a sophomore KSU student, decides to administer a survey to students in her dorm on their uses of tobacco. She plans to leave the surveys in a lounge with a cardboard box beside them for anonymous collection and will not gather any information (name, room number, student number, birth date) that could allow her to trace the data to their source. She will not observe students filling out the survey. In this case, Claire needs to seek review by the Vice President for Student Affairs. She does not need full IRB review.

 

Professor Scope gathers data at town meetings:
Professor Tony Scope wants to gather data for a paper she’s writing on speech-making by public officials. She’ll attend several public forums and town hall meetings, and will observe these officials in action. She’ll record, by means of pen and paper and a camcorder, what they say, how they sound, look and behave. Professor Scope does not need full IRB review for research on public officials.

 

Professor Halberstam collects data with a team of students:
Professor Michael Halberstam is conducting research with a team of undergraduates who’ll help him collect data. He is measuring, through the use of calipers, the ratio of fat to muscle on two groups of pre-menopausal women who have never had children. His study must be submitted to full IRB review.

 

MBA student does customer research:
Norris Jones, an MBA student, seeks to learn more about customer behavior. He plans to share his results with his colleagues in his honor society by posting the outcome on the society web site. He will interview children at local middle schools about their candy purchases. He will record their names and ages. Norris needs to seek full IRB approval for his study.