Research Using Human Subjects and Human Biospecimens
What is a Human Subject?
A 'human subject' is: a living individual about whom an investigator (whether professional or student) conducting research:
(1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
What Constitutes Human Subjects Research and Data Acquisition?
|Any systematic investigation (including research development, testing, and evaluation) involving intervention or interaction with individuals or using their personally identifiable information or materials, designed to develop or contribute to generalizable knowledge.
In addition to traditional biomedical and clinical studies, such research includes but is not limited to studies that—
(2) Use personally identifiable body materials such as cells, blood, tissues, urine, or hair, even if the materials were collected previously for a purpose other than the current research;
(3) Collect and use personally identifiable information such as genetic information or medical and exposure records, even if the information was collected previously for a purpose other than the current research;
(4) Collect personally identifiable or non-identifiable data, surveys, or questionnaires through direct intervention or interaction with individuals; and
(5) Search for generalizable knowledge about categories or classes of subjects (e.g., linking job conditions of worker populations to hazardous or adverse health outcomes).
(6) Human terrain mapping (HTM) or human terrain systems (HTS) studies (see definition)
(7) Research involving intentional modification of an individual’s or a group of individuals’ environment, for example, through installation of devices in homes and/or through introduction of gases/chemicals to trace airflow in occupied residential, commercial, or public settings (e.g., tracer gas studies in subway systems).
Human subject research does not include the following:
(1) Studies to improve the safety or execution of procedures that apply to routine occupational activities and environments;
(2) Occupational health surveillance of DOE Federal or contractor employees to determine apparent departures from typical health status and not for the purpose of obtaining generalizable knowledge;
(3) Employee surveys used as management tools to improve worker or contractor performance as long as the identity of the participant is protected;
(4) Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
(5) Public health surveillance activities;
(6) Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and
(7) Certain activities in support of intelligence, homeland, security, defense, or other national security missions.
(1) Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials;
(2) Residual diagnostic specimens, including specimens obtained for routine patient care that would have been otherwise discarded; and/or
(3) Private information, such as medical information, that can be readily identified with individuals, even if the information was not specifically collected for the study in question. Research on cell lines or DNA samples that can be associated with individuals also falls into this category.
Comply with your institution's rules and the requirements of your Institutional Review Board (IRB) as well as meeting all federal requirements (Title 45 CFR Part 46) in order to conduct your research. The IRB at your institution must review and approve research if it may involve human subjects. This process is designed to ensure that the research protects the rights and welfare of human subjects - for example, by minimizing risks, selecting subjects equitably, obtaining informed consent and ensuring privacy and confidentiality. In addition, after your Institution's IRB has approved the work, the Argonne IRB Coordinator must review the scope of work and the proposed collaborator list to determine whether the Central DOE IRB must be consulted as well. If any DOE or Argonne employees will be participating in the research, whether or not they end up as co-authors, the Central DOE IRB must be involved in the review.
Secondary Research with Identifiable Biospecimens or Information
Established human cell lines obtained from a well-recognized commercial source such as ATCC are considered automatically exempt and do not require review or approval from the IRB. However, biospecimens shared from other sources, such as a university tissue bank, or tissues obtained during clinical procedures do require IRB review. The IRB will determine whether the use of those materials is "exempt." Secondary research use of identifiable private information or identifiable biospecimens may fall under a number of exemptions identified through a limited IRB review.
What about specimens obtained from a tissue bank?
Use of biospecimens obtained from an established tissue repository may be exempt from IRB review. There are many kinds of tissue banks that operate in different ways; the mechanism used for tissue procurement and storage may differ. Your home IRB will need to determine whether the bank you are using meets the requirements of the federal exemption.
Human research information that is most frequently needed is available from the Health and Human Services (HHS) Office for Human Research Protections (OHRP). Information on this web site can help you determine whether your research falls under the human subjects regulations and, if so, whether it is likely to require full IRB review or is a candidate for expedited review. You should be aware, however that institutions vary in their requirements for IRB review. Many institutions require some form of IRB review for exempt studies. You must check with your institutional officials to determine whether full, expedited, or no IRB review is required for your proposed project.
If I obtain all my specimens from collaborators, do the regulations apply?
What if my collaborator is located outside the U.S.?
Your collaborator will need to obtain approval from the IRB at his or her institution. In addition, your collaborator's institution will probably need to contact the HHS OHRP and provide documentation that its IRB meets the requirements defined by U.S. law. An assurance coordinator at OHRP can assist you with this process. In addition, your program official may need to request State Department clearance for your project.
The key is: start early!
Obtaining approvals and assurances takes time, particularly if institutions are located overseas. No experiment can be run at the APS until the necessary approvals and assurances are in place prior to the start of the beam run. Contact the Argonne IRB Coordinator Dan Schabacker for help in the determination of what type(s) of review is required for your experimental materials.
Reviewed: January 2, 2019