What is the IRB?
The IRB, or Institutional Review Board, exists to protect human participants involved in research conducted by University members (faculty, staff, and students). For this reason we ensure that correct procedures, such as clearly stated release and consent prior to participation, are followed when human subjects are involved in research. Providing the University with supporting documentation helps to safeguard the University as well as the researchers from potential liability.
When do I need to apply for IRB approval?
All research projects involving human participants, conducted by faculty, staff or students, must be reviewed. Research, for this purpose is defined as a systematic investigation designed to develop or contribute to general knowledge. Research projects that fit under this classification include, but are not limited to, surveys and questionnaires, personal interviews, physical testing, diagnostic sample collection, etc.
Types of Reviews Conducted by the Henderson State University IRB
|
Risk |
Non-vulnerable participants: An individual capable of deliberation about personal goals and of acting under the direction of such deliberation. |
Vulnerable participants: Such as children, prisoners, pregnant women, or developmentally or physically disabled persons or individuals with diminished autonomy. |
| Less than Minimal | Exempt | Expedited of Full Board |
| Minimal Risk | Expedited | Full Board |
| Greater than Minimal Risk | Full Board | Full Board |
How do I receive an Human Subjects Protection certification?
To receive your human subjects protection certification go to this link: Office of Human Research Protections, register and complete the tutorial. You will need a code provided by Henderson State University. To receive this code, email kellyd@hsu.edu with your Henderson email and Identification number.
What are my responsibilities as an investigator?
When IRB approval is received by the investigator, it is her/her responsibility to follow the procedures that have been approved. If changes in procedures, number of subjects, location of research, etc. are needed, these changes must be approved by the IRB before they are started. It is the investigator’s responsibility to provide a yearly update on the progress of the project and inform the IRB at completion of the project.
What is the threshold of minimal risk?
Minimal Risk: the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life.
Less than Minimal: e.g.: self-completed questionnaires with no identifiers, observation studies where the investigator has no contact with the subjects, unobtrusive research.
Greater than Minimal: e.g.: collecting sensitive information from students where it is possible to link the student with their responses.
What are the types of risks?
Physical: In many situations, physical risks in research can be minimized by carefully and skillfully following protocols, by having trained individuals conduct research procedures, through careful monitoring of research participants’ health status, by recruiting appropriate populations, and by providing clinical care when needed.
Psychological: Possible ways to protect against psychological risks include reminding participants of their right to withdraw from research or limit their participation if they become uncomfortable, providing counseling or psychological support for participants who experience distress, or thoroughly debriefing research participants after research sessions are complete.
Social: Often, minimizing social risks to participants involves protecting confidential data, including not only the data collected, but the fact of participation itself.
Legal: Protections against legal risks often involve protection the confidentiality of research data. For studies conducted in the United States, investigators can apply for Certificates of Confidentiality which are intended to prevent investigators from being forced to disclose data that can be linked to identifiable research participants in legal proceedings.
Economic: Protecting confidentiality of data is one method for protecting against economic risks, such as those to employability and insurability. Investigators may elect to keep research data separate from medical records in order to prevent employers and insurance companies from obtaining information that could put the participants at risk.
Where do I get an application form for my study?