Human Subjects in Research 

Number:

4.15 (printable version)

Policy/Operational Procedure Name:

Human Subjects In Research

Sponsor:

Dr. Melanie Riester
Director, Institutional Research and Evaluation
Research, Evaluation, Assessment, and Planning (REAP)

Custodian:

Research, Evaluation, Assessment, and Planning (REAP)

Effective Date:

December 2011; September 27, 2019 (Revision)

Next Review Date:

2023-2024

Location:

durhamtech.edu/policies-and-procedures/human-subjects-research

Citation:

6 CFR § 1028.116
45 CFR part 46
21 CFR part 50
21 CFR part 56

 

Policy Statement

Durham Technical Community College establishes and follows procedures for reviewing internal and external research requests seeking students’ and/or employees’ voluntary participation in data collection and analysis. Researchers are held responsible for ensuring the rights and welfare of human subjects and providing prospective participants with legally effective informed consent.

Purpose

Durham Technical Community College (Durham Tech) encourages and supports the scholarly endeavors of its students and employees, as well as other educational institutions and reputable community organizations. Pursuit of scholarly work and research sometimes involves human subject participation where subjects’ data is collected and analyzed. When research conducted involves human subjects, it is necessary to ensure that the rights and welfare of the subjects are considered and protected; that risks have been considered and minimized; that the potential for benefit has been identified and maximized; that all subjects only volunteer to participate in research after being provided with legally effective informed consent; and that any research is conducted in an ethical manner and in compliance with established standards.

Individuals under the age of 18 are unable to give informed consent and cannot participate in human subject research without the consent of a parent or legal guardian.

Procedure

Research, Evaluation, Assessment, and Planning (REAP) must be notified of human subject research activities to ensure that the College is protecting the rights and privacy of its students and employees. Durham Tech does not have an institutional review board (IRB), and REAP does not approve or disapprove research at the College; however, REAP does reserve the right to deny requests that include students and employees in research activities.

To meet the definition of research with human subjects, the research must meet the federal definitions of “research” and “human subjects.” For example, if a researcher receives data with no identifiers from a colleague who interviewed subjects, the researcher is not conducting research with human subjects. Instead, the researcher has a research question, but does not have human subjects in the study because the researcher is not interacting with living individuals or collecting identifiable data from or about them. The researcher’s colleague conducted research with human subjects, but the researcher did not.

The following are examples of studies that may not meet the definition of research with human subjects:

  • Analysis of De-identified Data – Using data that are already aggregated, such as charts and graphics, which do not allow for disaggregation down to the individual level.
     

  • Expert Consultation – Key words in the definition of a human subject are "a living individual about whom" a researcher obtains information. At times, researchers’ information-gathering interactions with individuals do not result in the collection of identifying information. Expert consultation involves obtaining information from a professional with knowledge of a specific subject matter. This professional may share an informational summary or aggregated data about a topic or group of individuals, without providing identifying information. For example, a researcher may contact several community colleges within a state to get information on their student retention rates, without asking for any specific information on the students included in the rates.
     

  • Program Reviews, Evaluations, and Quality Improvement Studies – Not every study is designed to contribute to a field of knowledge. For example, if data are being collected to improve a program within the College and will be used only for that purpose, the collection of that information would not constitute research with human subjects. In these cases, employees should submit a data request to REAP via the work order system.
     

  • Classroom Research – Durham Tech students may be asked to conduct interviews, distribute questionnaires, or engage in participant observation on campus as part of their coursework. If the purpose of these activities is solely pedagogical and is not designed to contribute to a body of knowledge, the activities do not meet the definition of research with human subjects. However, classroom research must be supervised by a faculty member; may not include research subjects under the age of 18; and must not involve sensitive, personal, or incriminating topics.

    Faculty who teach research methods and/or oversee student research projects are expected to understand the philosophy, ethics, and practice of protecting human subjects in research; to adhere to these principles during the conduction and supervision of classroom research projects; and to teach these practices and principles to students. Faculty are responsible for ensuring that all student research projects are conducted in accordance with federal regulations and principles regarding protection of human subjects in research. Faculty members who have concerns or doubts should consult with REAP prior to having students conduct the research.

    Classroom research is outside the federal definition of human subject research. As such, classroom research projects do not need formal IRB approval and thus may not be presented at local, state, national, or international conferences; published; or used for thesis/dissertation projects. If a student wishes to present or publish the work in the future, the student, with faculty assistance, should seek approval from a properly constituted IRB and follow the steps for submitting a research request.
     

Researcher Expectations and Requirements

When considering requests for student and/or employee participation in human subject research, the College seeks to ensure that researchers respect subjects’ legal rights and consider their privacy, dignity, and comfort. Ongoing research activities are subject to periodic review at the College’s discretion. Researchers requesting student and employee participation as research subjects are subject to the following expectations and requirements:

  • Participation by a human subject in research must be voluntary, and the right to withdraw at any time must be provided;
     

  • Information provided to gain human subject consent must be adequate, appropriate, and presented in lay language appropriate to the subject population;
     

  • All research that involves human subjects must receive approval through a formally constituted IRB prior to initiation or prior to the initiation of any changes to the research protocol;
     

  • Research involving human subjects must be conducted by qualified individuals as defined by IRB regulations. Any research specifically involving medical and/or clinical assessments must be conducted by individuals specially qualified for that type of research (e.g., qualified clinicians for all study-related health care decisions);
     

  • Risks to subjects (if any) must be reasonable in relation to anticipated benefits (if any) and the importance of the knowledge expected to be gained;
     

  • Necessary provisions (facilities, personnel, etc.) and procedures must be in place to ensure the protection of subjects;
     

  • Unless scientifically justified, recruitment methods should seek to attract a subject population that is demographically representative of the population base;

  • Students who wish to participate in the research may voluntarily and privately respond to posted notices;
     

  • Allowing the posting of notices for research studies implies no review and/or endorsement of the study;
     

  • The College is not included in any contractual arrangement between the researcher and any Durham Tech student and/or employee; and
     

  • The researcher must assume all responsibility for the welfare of research subjects.
     

Submitting Research Requests

Researchers must submit a request via email to the Director of Institutional Research and Evaluation before conducting research of any kind. REAP must have the opportunity to review the request before any research can begin.

Research conducted by individuals affiliated with the College is the responsibility of the researchers making the request, and there should be no expectation that additional College resources, beyond the review of the documentation submitted, will be expended.

Regardless of College affiliation, researchers conducting human subjects research must submit the following information in writing to the Director of Institutional Research and Evaluation at least fifteen (15) working days prior to the intended project start date:

  1. Documentation that specifically addresses the researcher’s organizational affiliation, whether it is with the College or another entity;
     

  2. A brief description of the study, including its purpose and the methods used to recruit study subjects;
     

  3. Confirmation from the supervising institution showing IRB approval to conduct the research; and
     

  4. A copy of the IRB-approved consent form containing all of the following:

    1. Information that will be sent/read to participants stating the purpose and voluntary nature of the research;
    2. Interview and/or survey questions that will be disseminated to research participants;
    3. How the researcher will obtain the informed consent of the research participants;
    4. How the welfare, privacy, and confidentiality of the research subjects will be protected;
    5. Contact information for the individuals the participants may contact with questions and concerns; and
    6. Projected research start and end dates.

Upon receipt of all required documentation, REAP will review the request and contact the researcher within seven (7) working days. Additional information or clarification may be requested. Based on the request, REAP will provide supporting and supplemental information, such as College-approved survey dissemination practices. No research may begin until REAP has had the opportunity to review the documentation.

Definitions

Aggregated – Numerical or non-numerical information that is (1) collected from multiple sources and/or on multiple measures, variables, or individuals; and (2) compiled into data summaries or summary reports, typically for the purposes of public reporting or statistical analysis

Disaggregation – The breakdown of aggregated data into component parts or smaller units of data

Human Subject – 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.

Identifiable Private Information – Private information for which the identity of the subject is or may readily be ascertained by the researcher or associated with the information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects. Examples of identifiers include names, Social Security numbers, medical record numbers, or any other “code” that permits data to be linked to individually identifiable living individuals.

Institutional Review Board (IRB) – A specifically constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical, behavioral, or social science research

Intervention – Physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes

Legally Effective Informed Consent – A process and consent form that follows human subjects regulations; follows applicable federal, state, or local laws; and is correctly obtained from the subject or the subject's legally authorized representative. Legally effective informed consent minimizes the possibility of coercion and undue influence, is free of exculpatory language, emphasizes that the research is voluntary, and is properly documented.

PedagogicalRelating to the methods, practices and theory of teaching

ResearchA systematic investigation, including hypothesis development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for the purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Working DaysDays the College is open and operating under a normal schedule. This excludes weekends, closings due to adverse conditions, and holidays.