Human Subjects in Research Policy

Purpose:

Carteret Community College encourages and supports the scholarly endeavors of its students, faculty, and staff, as well as other educational institutions and organizations.  The College acknowledges pursuit of scholarly 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 are protected, the risks have been considered and minimized, and the potential for benefit must be identified and maximized.  For such research, all human subject participation is voluntary and only after provided with a legally effective process for informed consent.  Lastly, all research must be conducted in an ethical manner and in compliance with established standards.

Conducting Research for Personal Educational Purposes 

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

This policy applies to all research activities involving human subjects.  All individuals who propose to conduct human subjects research will need to prepare and submit an Application for Research to the Research Review Committee for consideration.  

Although not a true IRB, Carteret Community College’s Research Review Committee (RRC), consists of five members to include the Director of Institutional Effectiveness, a Research Technician, a representative from Student Services, a faculty member with expertise in scientific research, and a faculty member with expertise in social sciences.  The Director of Institutional Effectiveness serves as the chair.  

The RRC is responsible for the following:

1. Reviewing those proposals which need to be discussed by the whole committee (exempt or expedited proposals need only be approved or denied by the RRC Chair);
2. Insuring that vulnerable populations, risks to individuals, and risks to the College are properly protected before granting approval for the research to begin;
3. Reviewing copies of informed consent to be given to research participants where applicable;
4. Ensuring that prior approved research projects continue to be updated for review; and
5. Terminating and/or suspending projects when misconduct in research is reported and/or confirmed. 

For Researchers Affiliated with the College

The College supports researchers who have an affiliation with the College and who may be pursuing advanced degrees or seeking to conduct research using Carteret Community College 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 Application for Research, which includes the following items, to the Director of Institutional Effectiveness:

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 demonstrating 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, how the welfare of the research subjects will be protected, and whom the participants need to contact with questions regarding the research or with other concerns; and,
4. Projected beginning and ending dates of the research.

In the event the research under consideration is to be conducted by Institutional Effectiveness staff and meets the definition of human subjects research, the research application will be reviewed by the RRC, absent the Director of Institutional Effectiveness to assure appropriate checks and balances.

The following are additional expectations and requirements associated with research requests that propose using Carteret Community College students, faculty, and/or staff as subjects:

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 and the importance of the knowledge that may result from the proposed research;
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 at the College 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 specifically qualified for that type of research;
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 Research Review Committee.  Such review shall be carried out at least once a year.

For Researchers Not Affiliated with the College

Individuals or groups not affiliated with Carteret Community College who wish to conduct research using Carteret Community College students and/or employees as subjects must submit a request to the Director of Institutional Effectiveness. The Director of Institutional Effectiveness will review the request and, where appropriate, consult with the Research Review Committee to either accept or reject the request.  Researchers should submit the following items to the Director of Institutional Effectiveness:

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 demonstrating 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, how the welfare of the research subjects will be protected, and whom the participants need to contact with questions regarding the research or with other concerns; and,
4. Projected beginning and ending dates of the research.

The Director of Institutional Effectiveness or, when appropriate, the whole RRC will determine the means of notifying potential participants (i.e., email, LSM posting, electronic bulletin board) once a research request has been approved.  

The following are additional expectations and requirements associated with research requests that propose using Carteret Community College students, faculty, and/or staff as subjects:

1. Participation of Carteret Community College students, faculty, and/or staff in research using human subjects is strictly voluntary and only after legally effective informed consent is provided.  Participants have the right to withdraw at any time;
2. Allowing students, faculty, and/or staff to participate in research studies does not imply a review and/or endorsement of the study by any college employee;
3. The College is not included in any contractual arrangement agreed to between the research sponsor and any Carteret Community College student and/or employee; and 
4. The research sponsor must assume all responsibility for the welfare of research participants.

Definitions:

Source:  U.S. Department of Health & Human Services, Office for Human Research Protections, Code of Federal Regulations (2009) Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr46/index.html#46.102

Human Subject:  Carteret Community College defines a human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.”

Research: “a systematic investigation, testing and evaluating, 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.

Intervention:  “physical procedures by which data are gathered including 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.” Private information must be individually identifiable, that is the identity of the subject is or may readily be ascertained or associated in order to constitute research involving human subjects.  Examples of identifiers would include but are not limited to name, social security number, and medical record numbers.

Exempt from Review – Research exempt from review includes research conducted in established or commonly accepted educational settings such as the classroom.  In classes, students may be assigned to conduct interviews, distribute questionnaires, or engage in participant observations.  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.  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 students believe they may wish to present or publish their work at a future point, they, with the assistance of a faculty member, should seek approval from a properly constituted IRB that meets federal regulations and should follow the steps for approval for researchers affiliated with the college.

Expedited Review Procedures:  researchers may use an expedited review procedure for research involving no more than minimal risk to participants and for minor changes in research already approved by the Research Review Committee.

Minimal Risk:  the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life.