Human Subjects Review
Purpose of Policies and Procedures
US Federal Policy for the Protection of Human Subjects governs the conduct of research for all US educational institutions and incorporates the specific regulations from a variety of agencies including, for example, Department of Health and Human Services, USAID, and the Office for Civil Rights. AUBG complies with these research standards as well as those broad policies outlined in the applicable laws of the European Union and Bulgaria (including Regulation (EU) 2016/679 (General Data Protection Regulation) and the Personal Data Protection Act of 2002 www.ceecprivacy.org).
All research involving the use of human subjects imposes both ethical and legal responsibilities upon the researcher—whether student, staff, or faculty member—to protect the rights and welfare of the subjects. Although AUBG is not involved in medical, genetic, drug, or other types of research where the risks are greater, it is important to be attentive to all standards in order to provide a safe and professional environment for the conduct of research. These guidelines cover both research that is designed to contribute new knowledge (e.g. faculty research, student theses, independent studies) and administrative research (e.g. outcomes assessment, employer surveys) that is conducted to inform the AUBG community and improve institutional performance.
Please be informed that AUBG shall not be held liable for any damages occurring as a result from or related to any number of processing operation(s) that have not been duly reviewed and approved/authorized by the organization.
Scope of Committee Review:
The Committee’s role is to review and approve projects and/or make recommendations with regard to protection of participants. Research conducted on or off campus by faculty, staff, and students requires prior approval. Both the design and the data collection methods such as questionnaires, interview protocols, surveys, focus groups questions, tests, and observations need to be approved. Research standards apply to all student research, and faculty supervisors are responsible for reviewing student research projects and ensuring that once approved, they are carried out in the manner expected. Faculty may use their own judgment with regard to class assignments and projects. If in doubt, they may submit the syllabus and description of sample projects to the Committee for review.
Ethical Principles for Research with Human Subjects
In determining whether a project meets the necessary standards of respect for the dignity and autonomy of individuals and protection from harm, the following criteria are important:
- Voluntary participation:
Participation must be voluntary and based on full disclosure of relevant information so that the individual can make an informed decision, including disclosure of the details of the processing of the respondents’ data for the purposes of the study. Incentives to participate must not be such that the individual cannot exercise good judgment about whether participation is in his/her best interest. Faculty may not use their own students as subjects as it may be interpreted as affecting the course grade or changing the individual’s relationship to the group if they are one of the few who does not participate.
- Protection from harm:
Any risks to individuals in the study must be outweighed by the benefits of the knowledge to be gained. Potential risks can include physical, social, and/or psychological harm. In the application for approval of the project, researchers must demonstrate that they have adopted the appropriate safeguards to minimize potential harm, including technical and organizational measures for the security of the personal data.
- Informed consent:
A form outlining the purpose, procedures, time involved, and risks or benefits must be signed by all participants at the outset. To the extent that they are not covered by the document under the previous sentence, a personal data processing consent and a privacy notice regarding the study are to be provided to and signed by the participants. Researchers must also inform participants that participants may later decide to discontinue participation. Subjects under 18 must also obtain the signature of a parent or legal guardian. For anonymous surveys, a statement that describes the nature of the research is sufficient.
Deception is in direct conflict with informed consent. If it is necessary to withhold some pertinent information from subjects so as not to bias their responses and impair the validity of the study, the researcher will need to provide justification to the Committee. In all such cases, subjects should be told that they are being invited to participate in research in which some features will not be revealed until the research is concluded.
It is a fundamental right of all individuals to be able to maintain their privacy. Subjects should be assured of confidentiality and informed how the collected data will be treated at the conclusion of the study. This is particularly important if personal information is being collected that might be embarrassing or put the subject psychologically at risk if the information were made public.
Subjects have the right to ask questions, get additional information about the results of the research, check their perceptions, and so forth as part of a debriefing process to further ensure there is no harm to participants. In many cases, there will be no need for debriefing.
Categories of Review
There are three categories of reviews: exempt, expedited, and full review. The type of review required depends upon the nature of the research, the subjects, and the risk imposed upon the subjects. Expedited reviews are conducted by the chair of the Committee. Full reviews are conducted by the entire Committe
- Exempt from Review:
Research that is exempt from review deals with non-sensitive topics, involves subjects who are able to consent to participate, and the anonymity and confidentiality of subjects is maintained. This includes the type of research normally carried out in educational settings such as research on instructional effectiveness and surveys of service satisfaction.
- Expedited Review:
Expedited review is for studies that involve no more than minimal risk such as survey research or program evaluation that provides anonymity and confidentiality. Examples include employer and alumni surveys. The chair of the Committee and one faculty member can conduct an expedited review.
- Full Review:
The full Committee will meet on proposals that involve vulnerable subjects, sensitive behavioral research, research involving deception, or research where the risk of harm is greater than what one would encounter in daily life. Typically an informed consent form is required. Cooperative Research with Another Institution
Faculty conducting research with colleagues at another institution may choose to have the project approved by the appropriate committee at the other institution. In that case, the cooperating institution assumes all responsibilities. As such research may be in an international setting, the researcher should be sure he/she understands the relevant laws, community standards, cultural norms, and other institutional policies. If a researcher from another institution comes to AUBG to conduct research, the Human Subjects Committee will provide the necessary approvals and guidance.
The Committee is appointed annually by the President and has at least one faculty member from a department that routinely conducts research. The Committee meets as needed, and proposals should be filed at least two weeks in advance of when the project is to begin. The Committee will respond in writing and may give conditional approval with a statement of required changes. The researcher may meet with the Committee if additional information is needed.
Requesting Committee Review
The following information must be provided to the Committee:
1. Title of the Research.
2. Researcher’s full name.
3. Duration of the Study.
4. Purpose of the Study.
5A: Estimated number of participants;
5B: Categories of personal data processed, including information, whether the study involves the processing of special categories of personal data
6. Procedures for selection of participants.
7. Description of the procedures to be used in the study
8.Copy of survey, questionnaire, or any other instruments.
9. Explanation of possible risks.
10. Methods for minimizing risks (training, maintenance of files, etc.
10A: Safeguards /technical and organizational measures/ for the protection of personal data
11. Informed consent form (click for a template here): Typically it states
“My signature confirms that:
- my participation is voluntary,
- I understand I can discontinue my participation at any point,
- the purpose of the study has been explained to me along with any risks,
- I know that I can ask questions at any time,
- and it has been made clear that the study is anonymous and/or confidential.”
12. Privacy notice with the following information:
- identity and contact details of the controller and, where applicable, of the controller's representative;
- contact details of the data protection officer, where applicable;
- the purposes of the study;
- the recipients or categories of recipients of the personal data, if any;
- where applicable, the fact that the controller intends to transfer personal data to a country or an international organization outside the EU;
- the period for which the personal data will be stored;
- the existence of the right to request from the controller access to and rectification or erasure of personal data or restriction of processing concerning the data subject or to object to processing as well as the right to data portability;
- the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal;
- the right to lodge a complaint with a supervisory authority.