Defining research with human subjects is not always easy.
To meet the definition of research with human subjects, one or more of the following must be true:
- You are conducting a pilot study or other preliminary research; or
- You have designed a study to collect information or biospecimens in a systematic way to answer a research question; or
- You intend to use, study, analyze, or generate identifiable information or biospecimens collected by someone else.
And you must be doing one or more of the following:
- Interacting with living human beings to gather data about them using methods such as interviews, focus groups, questionnaires, and participant observation; or
- Conducting interventions with living human beings such as experiments and manipulations of subjects or subjects' environments; or
- Observing or recording private behavior (behavior that individuals have a reasonable expectation will not be observed and recorded); or
- Obtaining private identifiable information that has been collected about or provided by individuals, such as a school record or identifiable information collected by another researcher or organization.
For definitions found in the regulations and vignettes to see how they are applied, see the Guide to Defining Research with Human Subjects.
The Campus IRB reviews research conducted by faculty, students, and staff in the Arts and Sciences, the Schools of Engineering, Law, Business, Divinity, and the Environment, as well as Campus institutes, centers, and programs, including the Duke Global Health Institute.
If a campus researcher plans to conduct research at a Duke Medicine facility, or plans to access Protected Health Information (PHI) held by the Medical Center, the protocol must be submitted to a Duke Medicine IRB.
However, the Campus IRB may review some collaborative studies between Campus and Duke Medicine researchers and may review the collection of biological samples and data for studies in the social and behavioral sciences.
If the research is sponsored by Duke University Health Systems (DUHS) or a DUHS component, the protocol will need to be reviewed by the Health IRB.
The Campus IRB can review collaborative research when:
- An investigator from a campus academic unit will collaborate with a Duke Medicine researcher to conduct a study in the social and behavioral sciences, provided the research not take place at a Medical Center facility or use PHI held by Duke Medicine.
- A graduate student or undergraduate student from a campus academic unit asks a researcher from Duke Medicine to serve as an advisor, provided the research will not take place at a Duke Medicine facility or use PHI held by Duke Medicine.
Collection of Biological Samples and Data
The Campus IRB may review a study in the social and behavioral sciences that will involve non-invasive procedures to collect biological samples and data. Examples of biological specimens include saliva, and hair and nail clippings. Physiological data collection includes measuring weight, testing sensory acuity, as well as the collection of data through galvanic skin response electrocardiography, electroencephalography, and thermography. The Campus IRB may also review research involving moderate exercise activities. The full list of procedures can be found in Research Eligible for Expedited Review: Federal Register 1998.
Biological samples also include blood collection, as described in the list of research activities eligible for expedited review.
- Note: If the biological samples are collected or analyzed in a lab that is part of a Duke Medicine facility, the protocol must be reviewed by a Duke Medicine IRB.
If you are collaborating with researchers at other institutions or organizations in the US or abroad, please contact IRB staff before you begin writing your protocol.
If you plan to hire individuals or firms to help you conduct the research, please contact us.
Why? We don’t want you to spend time preparing material the IRB doesn’t need, omit information that should be included in the protocol, or delay your research due to agreements or contracts with other institutions or individuals that must be put in place.
If your proposed research will be physically conducted outside the U.S. or you plan to collaborate with a foreign entity please contact the Duke University Office of Export Controls for approval.
Information is considered individually identifiable if it could reveal the identity of a participant, either directly (e.g. name) or through deductive disclosure (e.g. a combination of unique characteristics, such as a student's gender, year in school, major, and athletic affiliation).
Information is sensitive if an inadvertent release of that information could cause potential risk of harm to the participant. Some examples of sensitive information include a subjects' mental health, sexual behavior, or illegal behavior, such as underage drinking or drug use.
Also note that the University has determined any research studies that collect or use direct (e.g., names) or indirect (e.g., demographics) data about Duke students meets the "sensitive" data classification, because the data must be protected to mitigate institutional risk.
What you need to do
If you are collecting individually identifiable information about participants that is sensitive:
- Your protocol will need to include a data security plan. The IRB staff will pre-review the plan and forward it to Duke’s Information Technology Security Office (ITSO). The IRB staff have worked with ITSO to create guidelines for acceptable and recommended data protection procedures, including a list of approved servers for storing sensitive data.
- You may also need a Certificate of Confidentiality (CoC). Contact the IRB to determine whether you will need a CoC.
The protocol can be reviewed by the IRB, but final approval cannot be issued until ITSO has reviewed the data security plan.
Obtaining a CoC and ITSO review will add to the time needed to secure IRB approval.
Please note that undergraduate students cannot collect or access identifiable sensitive information about other Duke undergraduate students.
These things happen, and that is all right. We hope you do not get too distressed.
If you have not already, please review our guide on Subject Complaints, Setbacks and Other Problems & Issues, and our policy on Reporting Problems. We provide more information and some possible next steps.
If you are a student researcher, please get in touch with your faculty advisor as soon as possible.
Also you can always (and probably should) contact us.
Campus IRB staff work remotely and are available via email and by phone during regular business hours (Mon-Fri, 8AM-5PM). If you have any questions or concerns about your protocol or the IRB process, contact IRB staff.
We have posted guidance specifically related to amending an approved protocol in response to the enforcement and implementation of as well as the easing and lifting of COVID-19 restrictions.
You can also visit Duke's Coronavirus Response page for the most current updates related to the COVID-19 pandemic, including guidelines that might affect your research. The Campus IRB encourages all researchers to be aware of local coronavirus prevention guidelines and restrictions that may be in place at their research site.