Planning Your Submission
If you are confident your work falls within the definition of human subjects research, you will need to ensure that you have certain information about the research available for the IRB to review. The eProtocol form will request information covering a range of subjects, allowing reviewers to understand the scope of your research, the risks it may present, and more.
Identify Subject Populations
It is important to consider who is a human subject in the research. When identifying human subjects, both those who are interacted with and those who may not be interacted with but have private identifiable information about them collected should be included. This means a “human subject” could be a living person or a specific set of data points.
In the IRB protocol, the “Subject Checklist” provides a list of specific populations which require additional information or consideration for any potential vulnerabilities. In particular, studies which include children (minors), prisoners, and pregnant women prompt specific considerations by the IRB to ensure that their inclusion in the research is appropriate and risks are adequately mitigated.
In the “Subject Population” tab, the investigator is asked to describe the subject population. Non-exempt studies are required to provide a total number of subjects, and all research must include a description of criteria that include or exclude individuals from the subject population.
Consider Risks Presented by Research
The IRB is tasked with ensuring that all risks to human subjects presented by research are minimized, and researchers must have a plan for anticipating reasonably foreseeable risks and implementing protection procedures to reduce or eliminate them. The protocol will ask for a description of risks related to the research, and an assessment of whether the investigator believes the research presents "minimal risk" to subjects.
Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as noise, electric shock, heat, cold, electric magnetic or gravitational fields, and so on. Physical risks could also be presented by activities that subjects are asked to complete, such as physical endurance testing, exercise, and other repetitive movement tasks.
Psychological risks include the production of negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Emotional distress resulting from psychological harm is not always possible to anticipate, but some research may involve particularly sensitive subject matter which can reasonably be expected to increase psychological risk.
Social/Economic risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. Economic risks include loss of wages or other income and any other financial costs, such as damage to a subject's employability, as a consequence of participation in the research.
Loss of Confidentiality
In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Subjects have the rights to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data. In order to minimize the risk for loss of confidentiality, investigators should only collect personal information that is absolutely essential to the research activity. If personal data must be collected, it should be coded as early in the activity as possible and securely stored so that only the investigator and authorized staff may access it. Identities of individual subjects must never be released without the express consent of the subject. In addition, if an investigator wishes to use data for a purpose other than the one for which it was originally collected and the data are still identifiable (e.g. a code list for the data still exists), the investigator may need to obtain consent from the subjects for the new use of the data.
Legal risks exist when the research methods are such that the subject or others will be liable for a violation of the law, either by revealing that the subject or others have or will engage in conduct for which the subject or others may be criminally or civilly liable, or by requiring activities for which the subject or others may be criminally or civilly liable
Plan a Process to Obtain Informed Consent
In research where a human subject is interacted with, informed consent may be an ethical expectation (in Exempt research) or a regulatory requirement (In Expedited and Full Board research). In all cases, the process of obtaining effective informed consent should be carefully planned by the investigator.
Consent for participation in research requires an informed consent process. This process involves an information exchange and on-going communication that takes place between the investigator and the potential research participant.
The consent process starts with the initial presentation of a research activity to a prospective subject (including advertisements and notices), continues with a discussion and information exchange between the researcher and the prospective subject, and requires documenting that consent was obtained. The process may also be ongoing through the research activity until the participant decides to end his or her participation or until the study closes.
To ensure an effective informed consent process, researchers should do the following:
Conduct the process in a manner and location that ensures participant privacy, as appropriate
Obtain the prospective subject’s voluntary agreement to participate
Give adequate information about the study in a language understandable to the potential subject
Document the consent
Provide adequate opportunity for the potential subject to consider all options
Provide copies of the consent documents to the subjects, if requested
Respond to the potential subject’s questions or concerns
Continue to provide information as the subject or research requires
Ensure the potential subject’s comprehension of the information provided
Several additional considerations are important for obtaining effective informed consent:
Informed consent from the subject and/or his legally authorized representative must be obtained prior to initiating any research activities, including screening procedures unless the IRB grants a waiver to do otherwise.
Communication During Study
While the initial verbal explanation and dialogue with the subject are critical so that subjects know what they are agreeing to before they consent, ideally the consent process should be an ongoing conversation throughout the course of the study. Throughout the study, investigators should be available to answer questions and encourage subjects to ask questions or voice concerns, tell subjects about changes in the study procedures or risks or alternatives, and allow subjects to withdraw from the study for any reason at any time.
Qualifications of Person Obtaining Consent
Principal Investigators are responsible for assuring that all investigators obtaining consent are qualified and appropriately trained to explain the research and assess participant comprehension as described below. Any person who may obtain consent in a study should be listed in the IRB application.
Participants should be able to understand the nature and consequences of the study. If they cannot, consent from a legal authorized representative may be required. Depending on the subject population, the research interventions, and the context of the study, a plan for assessing a potential subject's capacity may need to be included in the IRB protocol.
Sample IRB Protocols
Examples of completed protocols- Full Board, Expedited, and Exempt- are available in the eProtocol system. After logging into eProtocol, navigate to the "Information Resources" frame at the bottom of the investigator dashboard. Annotated protocols that have been approved are provided as a reference.