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.
While most of the changes that went into effect with the revised Common Rule apply to biomedical research, there are three main changes that Campus researchers should be mindful of when writing new or managing existing protocols.
- Informed consent: There are new required elements of informed consent. There are also new criteria for waiving required elements as well as waiving the requirement to document consent. We anticipate the biggest change for Campus researchers will be to ensure each consent process includes a subheading titled Key Information and a statement informing participants whether their identifiable or de-identified data may (or may not) be made public or used for future research purposes.
- Continuing review: Although the Final Rule no longer requires continuing review (what used to be called a renewal) to occur “no less than one year” from the approval date, the Campus IRB has adopted a modified continuing review process we are calling a “check-in.” Similar to the old renewal process, researchers will be asked to submit a completed Periodic Check-In Form before a protocol’s expiration.
- Exempt research: In addition to expanded flexibilities in the exiting exemption criteria, there are new categories of exempt research. While we will take full advantage of the flexibilities now provided in existing exemption criteria, the new categories will not apply to Campus-based research.
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.
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 the collection of biological samples and data, using non-invasive procedures. Examples of biological specimens include hair and nail clippings, and saliva. Physiological data collection includes weighing, 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 using moderate exercise. 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 the IRB staff before you begin writing your protocol.
If you plan to hire individuals or firms to help you conduct the research, please call.
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 waiting for agreements with other institutions or individuals to be put in place.
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.
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.