p>At the University of New Hampshire (UNH), any UNH faculty, staff, or student who intends to conduct research that involves people must apply for and receive unconditional Institutional Review Board (IRB) approval (approval without contingency) before beginning the research. This applies to ALL research involving people, not just clinical research or research that is externally-sponsored. Social science, behavioral, historic, and linguistic research must be reviewed by, and receive approval from, the IRB (this is a representation of likely studies, and not an exhaustive list) if it involves human subjects.
The IRB is charged with reviewing and overseeing human subjects research conducted under the auspices of UNH. The first question to consider with respect to IRB review is whether the research project fits the definition of “research” with “human subjects,” as those terms are defined in the federal regulations that govern human subjects research. In light of the IRB’s mission to protect human subjects, and the potential regulatory consequences of not obtaining IRB approval for human subjects research, you should choose to err on the side of caution and consult the IRB [contact Melissa McGee (603) 862-2005, Susan Jalbert (603) 862-3536, or Julie Simpson (603) 862-2003] when you are uncertain whether your study is considered to be human subjects research.
1. Human Subjects
Federal regulations provide the following definitions:
Human subject: “Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)(1)].
Identifiable private information: “Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.” [45 CFR 46.102(e)(5)].
Using this definition of human subjects, all activities involving prospective collection of information about individuals via intervention/interaction are considered using human subjects and require UNH IRB approval before commencing.
Other pertinent information/definitions:
Living individual: Cadavers, autopsy specimens, or specimens/ information from subjects who are now deceased are not “human subjects.” The health information of deceased individuals, however, is protected under federal and some state regulations. If you plan to analyze health information of deceased individuals for your project, you should determine whether the health information associated with the data is “Protected Health Information” (PHI) under the HIPAA Privacy Rule.
About whom: To be considered research with “human subjects,” the data received from a living individual must be about the person. For example, if you are asking people for information on institutional policies, practices, and characteristics without obtaining data about the characteristics/opinions of the individuals providing the information, that does not involve research with human subjects (e.g., a survey asking institutional human resources offices about the number of individuals who work at an institution and what types of employee benefits are offered by the institution).
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between researcher and subject.
When studies involve the use of secondary/existing data (data/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]), and the secondary/existing data do not contain private information, UNH IRB approval is NOT needed to use such data for research purposes. Some common examples of secondary/existing data that are not considered private information include, but are not limited to:
- Some information on the internet - comments on TripAdvisor; content of public tweets and blogs; information on public Facebook pages; census information; freely-available datasets (whether or not anonymous)
- Archives - identifiable information about individuals in a public archive
- Datasets - anonymous datasets, whether privately held or publicly available
Important: Researchers should be aware that not all information on the internet is considered publicly available and not all datasets that are characterized as anonymous actually are. Examples include, but are not limited to: Comments on a non-public chatroom or listserv; restricted-access datasets; or privately held datasets where individuals may be identified, either directly, through a code associated with a name, or through a combination of variables. As the UNH IRB DOES NOT give post-hoc approval, researchers must be certain that the secondary/existing data do not contain private information before use. Further, some journals require proof of IRB approval for research projects that the UNH IRB may not consider to involve human subjects (e.g., use of anonymous datasets). Researchers should check journal requirements before conducting the project and contact the IRB with any questions.
In general, the federal Office for Human Research Protections (OHRP) considers private information/ specimens to be individually identifiable when they can be linked to specific individuals by the researcher either directly or indirectly through coding systems. "Coded" means that:
- Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
- A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
OHRP does not consider research involving only coded private information or specimens to involve human subjects if the following conditions are both met:
- The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
- The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
- The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement);
- There are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
- There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
For further explanation of these conditions, see the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens (link is external).
Federal regulations define research as, "A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(l)]. The regulations state that the following activities are not deemed research:
“(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.” [45 CFR 46.102(l)].
To apply the definition of research to an activity, you must look at the intent of the investigation, the researcher’s relationship with the subjects, and how the data will be used.
Activities at UNH involving human subjects commonly fall into the following categories:
Research - the purpose of the activity is to contribute to generalizable knowledge and data gathered may be shared with a research community or the public at large. UNH considers any project conducted for an undergraduate honors thesis, a master’s thesis or a dissertation to be research.
Evaluation/Assessment/Service/Reporting - the purpose of these activities is, upon request, to gather data to measure the current situation in regard to a specific phenomenon or set of factors. Data gathered may be shared only with the sponsor /client/requesting party and where appropriate, the faculty advisor, or used for internal decision making or informational purposes.
Classroom Assignments/Educational Inquiry/Practice - the purpose of these activities is the education of an individual student through an inquiry or experiential approach to discover known principles or phenomena. Data gathered may be shared only with the course instructor or faculty advisor, or in the case of an internship/practicum, the collaborating party.
Examples of studies that ARE considered research with human subjects:
- Studies that utilize test subjects for new devices, products, drugs, or materials (see the UNH IRB's Guidelines for Use of External IRBs and Single IRBs).
- Studies that collect data through intervention or interaction with individuals, if the information is about the individuals (including their opinions/views/thoughts). Examples of this type of research include behavioral interventions, surveys, studies that involve deception, research involving risky behaviors or attitudes, focus groups, and open-ended interviews with minors that contribute to generalizable knowledge.
- Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
- Studies that use human bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if the researcher did not collect these materials for the study. However, such research may not be considered human subjects research if the materials/data are coded and the investigator does not have access to the coding systems. Guidance on research involving coded private information or biological specimens is available on the web.
- Studies that produce generalizable knowledge about categories or classes of subjects from identifiable private information.
- Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications to their living or working space or test chamber.
There are certain circumstances, however, when the UNH IRB cannot review a research study involving human subjects due to its limited resources and expertise. In these circumstances only, UNH researchers must instead utilize the services of a qualified, accredited external IRB to be the IRB of record for these studies. Such studies include:
- Multi-site clinical trials,
- Studies involving drugs, agents, biologics, devices, or other other products regulation by the U.S. Food & Drug Administration (FDA), or
- Industry-initiated or industry-sponsored research.
Read these guidelines for more information on the use of external IRBs.
Departmental Review Committees (DRC) have been established at UNH to facilitate the IRB's responsibility for protecting human subjects by reviewing no more than minimal risk research projects generated within a department. Such authority, when granted, extends only to protocols that qualify for Exempt level review at UNH. Currently, DRCs exist in the psychology department.
Examples of studies that are NOT considered research with human subjects:
- Data collection for internal departmental or other University administrative purposes. Examples: teaching evaluations, customer service surveys.
- Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Example: a survey of employers that asks whether the employers offer certain employee benefits programs, without asking for the opinions or thoughts of the individuals who respond to the survey.
- Activities involving human subjects within the context of research methods courses generally do not require IRB review, unless the results will be used for research purposes (e.g., presented at the UNH undergraduate or graduate research conferences, used in a thesis or dissertation, research conducted under the auspices of the Hamel Center for Undergraduate Research).
- Program evaluation/quality improvement/quality assurance projects are generally not considered research if these activities are designed specifically to assess or improve performance within a department, hospital or classroom setting. The intention of the project is not to generate conclusions that can be applied universally, outside of the immediate environment where the project occurs. To ascertain whether a proposed quality improvement activity also qualifies as research (thus requiring IRB review), consult the Office of Human Research Protections (OHRP) guidance on quality improvement activities.
Special note on oral history projects and other ethnographic/qualitative interviews:
It can be challenging to determine whether projects that involve oral history interviews are human subjects research. As with all studies, the question involves looking at the research design and procedures using the definitions of “research” and “human subjects” set out in the federal regulations. Generally speaking, if a project is limited to interviews that document a specific historical event or that focus directly on the specific individuals about whom the information is collected, the project would not be considered human subjects research because it is not designed to have predictive value or lead to development/testing of a hypothesis. Many oral history projects fall within the same area as journalism, biography, and documentaries -- that is, they are intended to create a historical record of individual lives or of individual or community experiences. If the project is intended to produce generalizable conclusions (i.e., data collection intended to test economic, sociological, or anthropological models/theories) or to inform policy, the project is considered human subjects research and should undergo IRB review. Because this is a particularly challenging area in which to determine whether IRB review is needed, the IRB strongly recommends that indivdiuals contact the IRB [Melissa McGee (603) 862-2005 or Julie Simpson (603) 862-2003] if unsure whether a project that will involve oral history methods should undergo IRB review.
Important: Individuals gathering data from human subjects as part of evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice abrogate their rights to publish data as research data; if they choose to share observations with others, their actions ought to be governed by the ethical standards of their discipline (e.g., American Psychological Association or American Anthropological Association). Individuals who wish to gather data from human subjects as part of evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice AND intend to use the data as research data for the purpose of publishing or sharing with a research community or the public at large, must obtain IRB approval PRIOR to conducting the activity.
The UNH IRB recognizes that human subjects may be harmed by unethical or careless activities resulting from evaluations, assessments, service, reporting, classroom assignments, educational inquiry, or practice. As a board that values the protection of human subjects and the conduct of ethical behavior, the board strongly disapproves of such unethical behavior. However, the IRB recognizes the limits of its mandate and authority.
Additional information is available on the IRB’s Human Subjects FAQs webpage, as well as the IRB’s Application Resources webpage. Please contact Research Integrity Services (RIS) staff [Melissa McGee (603) 862-2005, Susan Jalbert (603) 862-3536, or Julie Simpson (603) 862-2003] with questions.
The Knowledge Base contains forms, instruction and training material, policies, guidance, tools, and other resources to support your research efforts by topic area.
Melissa McGee, Compliance Officer
Research Integrity Services
Service Building, Room 106B
51 College Road
Durham, NH 03824
Phone: (603) 862-2005
Susan Jalbert, Compliance Officer
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-3536
Julie Simpson, Director
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-2003