Human Subjects in Research 

Number:

4.15

Policy/Operational Procedure Name:

Human Subjects In Research

Sponsor:

Tina Bryant-Allen, Assistant Vice President, Research, Evaluation, Assessment, and Planning (REAP)

Custodian:

Research, Evaluation, Assessment, and Planning (REAP)

Effective Date:

December 2011

Next Review Date:

2018-2019

Location:

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

Citation:

N/A

 

Policy Statement

Durham Technical Community College establishes and follows procedures for approving requests from internal and/or external researchers seeking Durham Technical Community College students and/or employees to participate in data collection and analysis. Any human subject research will be allowed on a voluntary basis only. Requestors will be responsible for ensuring the rights and welfare of human subjects in the research and providing prospective participants with legally effective informed consent.

Procedure

NOTE: Persons under the age of 18 are unable to give informed consent and cannot participate in human subjects research without consent of their parent or legal guardian.

Researchers Affiliated with the College Conducting Research for Personal Educational Purposes

Although Durham Tech does not have its own Institutional Review Board (IRB), the College supports researchers who have an affiliation with the College and who may be pursuing advanced degrees or seeking to conduct research using Durham Tech students or employees for publication purposes or other purposes not funded by or sponsored by the College as official College research. Researchers should submit the following information to the Assistant Vice President, Research, Evaluation, Assessment, and Planning (REAP):

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

  2. Affirmation from the supervising institution showing Institutional Review Board (IRB) approval to conduct the research;

  3. A document containing the information that will be sent/read to participants stating the purpose of the research, how the researcher will obtain the informed consent of the research participants (e.g., copy of the IRB-approved consent form), how the welfare of the research subjects will be protected, and who the participants need to contact with questions regarding the research or other concerns; and,

  4. Projected research start and end dates.

In the event the research under consideration is to be conducted by REAP and meets the definition of human subjects research, the research documentation (items 1 – 4 above) will be reviewed by the dean of Health Technologies and the director of the Clinical Trials Research Associate program to assure appropriate checks and balances.

All approved research conducted by those affiliated with the College is the responsibility of the researcher(s) making the request and there is no expectation that additional College resources, beyond the review of the documentation submitted, will be expended on the research.

To meet the definition of research with human subjects, an individual must be conducting research as defined and obtaining information from human subjects in the research. For example, if an individual receives data with no identifiers from a colleague who interviewed subjects, he or she is not conducting research with human subjects. Instead, the individual has a research question, but does not have human subjects in the study because he or she is not interacting with living individuals or collecting identifiable data from or about them. (The individual’s colleague conducted research with human subjects, but he or she did not.)

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

Analysis of de-identified data

Expert consultation – key words in the definition of a human subject are "a living individual about whom" a researcher obtains information. Some interactions with people for the purpose of collecting information do not collect any information about that person. For example, a researcher may contact a non-governmental organization to ask about its sources of funding.

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 institution and will be used only for that purpose, the collection of that information would not constitute research with human subjects.

Classroom research – in classes, students may be assigned to conduct interviews, distribute questionnaires, or engage in participant observation. 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 should not involve sensitive, personal or incriminating topics. Faculty teaching research methods and/or overseeing 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 conduct and supervision of classroom research projects; and to teach these practices and principles to students. Faculty will be responsible for ensuring that all student research projects are conducted in accordance with federal regulations and principles regarding protection of human subjects in research. If the faculty member has concerns or doubts, s/he should consult with the Assistant Vice President, Research, Evaluation, Assessment, and Planning prior to having students conduct the research. Classroom research is viewed as being outside of the federal definition for human subjects research. As such, these projects do not have 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 believes they may wish to present or publish their work at a future point, the student, with the assistance of a faculty member, should seek approval from a properly constituted IRB that meets federal regulations as such, and should follow the steps for approval for researchers affiliated with the college.

Requirements of Researchers Making a Request

With respect to research requesting participation by Durham Tech students, faculty, and/or staff as subjects, the following are expectations and requirements:

  1. Subjects’ legal rights will be respected and their rights to privacy, dignity, and comfort will be considered in approving proposed research;

  2. Risks to subjects, if any, must be reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result;

  3. Adequate provision(s) must be made for all facilities, procedures, and professional attention necessary for the protection of the individual as a research subject;

  4. Adequate provisions are to be made for recruiting a subject population that is representative of the population base in terms of demographic representation unless scientifically justified;

  5. Research involving human subjects must be conducted by qualified persons and any research specifically involving medical and/or clinical assessments must be conducted by persons specially qualified for that type of research (e.g., qualified clinicians for all study-related health care decisions);

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

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

  8. All research that involves human subjects must receive approval through a formally constituted review prior to initiating the research or prior to initiating any changes to the research protocol; and

  9. Continuing research programs are subject to periodic review by the College, at the College’s discretion. Such review may be carried out at least once a year.

Researchers Not Affiliated with the College

As a general rule, individuals or groups not affiliated with the College who wish to conduct research using Durham Tech students and/or employees as subjects will be permitted only to post notices about their research study on public bulletin boards available on campus. The individual or group wishing to post notices may use the following community information bulletin boards and must abide by the following procedures governing their use as found in the Procedures for Posting Flyers and Signs on Durham Technical Community College Campuses. Researchers posting notices on the College’s campus are to be aware of the following:

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

  2. Allowing the posting of notices for research studies implies no review and/or endorsement of the study by any college faculty or staff member;

  3. The College is not included in any contractual arrangement agreed to between the research sponsor and any Durham Tech student and/or employee; and

  4. The research sponsor must assume all responsibility for the welfare of research subjects.

Purpose/Definitions 

Durham Technical Community College encourages and supports the scholarly endeavors of students, faculty, and staff of the College, as well as other educational institutions and reputable community organizations. Pursuit of scholarly work and research will often involve the use of human subjects for data collection and analysis. In conducting such research, it is necessary to ensure that the rights and welfare of human subjects used in research studies by College personnel are protected; that risks have been considered and minimized; that the potential for benefit has been identified and maximized; that all human 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.

Human Subject – DHHS regulations under 45CFR46.102(f) define a human subject as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.”

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

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

Private Information – “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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.” Examples of identifiers, would include names, social security numbers, medical record numbers, or any other “code” that permits data to be linked to individually identifiable living individuals.

Reference: Code of Federal Regulations 45 CFR 46.102