2.11 | Responsible Conduct of Research

Conducting research in responsible manner and scientific investigation with integrity involve the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.

Sampoerna University recognizes the curricular importance of faculty and student research and supports such endeavours with a variety of internal and external grant programs. The University is also committed to the responsible and ethical conduct of research and ensures compliance through the Office of Community Research and Community Service (CRCS).

2.11.1 | Responsible Conduct of Research

Faculty, students, and key personnel working research projects (regardless of source of funding) should be familiar with current guidelines for responsible conduct of research. These guidelines may apply to specific types of compliance issues (i.e. human subject in research) or to more general questions (i.e. mentoring and authorship). Faculty working with students on research projects are responsible for ensuring that students are aware of and comply with applicable laws, University policies, and professional norms related to responsible and ethical research practices. Furthermore, faculty are encouraged to make notes, in laboratory records or other files, providing information about information and mentorship they have provided to students regarding the responsible conduct of research.

2.11.2 | Responsible Conduct of Research Components

1. Mentor/Mentee Responsibilities and Relationships
   Adequate and supportive mentoring is a critical aspect of building a scientific community. Appropriate relationships, adequate training and preparation for mentees, and reasonable work requirements are all important aspects of the mentor/mentee relationship.
2. Research Misconduct
   The University has policies and procedures for addressing research misconduct. They are detailed in the Faculty Code and the Student Code. Engaging in research misconduct can result in serious consequences for both faculty and students. Misconduct includes, but is not limited to:
   1. Fabrication of data;
   2. Falsification of data; or
   3. Plagiarism
3. Peer Review
   Peer review should be expert, timely and constructive. Agreeing to serve as a reviewer indicates that there are no conflicts of interest that might impact the review, and that the reviewer has adequate expertise to serve in that capacity. Manuscripts, grant proposals, books and other materials are considered confidential while under review.
4. Data Acquisition, Management and Ownership
   Researchers are responsible for the integrity of their data, including acquiring, managing, and storing information. Lab notebooks and observations are considered part of the research record. A long term data management plan is recommended for projects. In collaborative projects, ownership of data should be determined well before the project begins.
5. Authorship and Publication
   Although authorship conventions vary by discipline, in most cases, the “first” author of an article, chapter or book is the individual who has made the largest contribution to the writing, analyses and other work involved in the publication.

2.11.3 | Human Subjects Ethical Research Practices

1. University Review Board
   Sampoerna University affirms that human research subjects will be treated with dignity, respect, and with due regard for their welfare. To protect human research subjects, the University, through the Office of Community Research and Community Service (CRCS), has established a University Review Board. The University Review Board is an ad hoc Task Force, appointed annually to include five (5) members: one faculty member from each Faculty, a faculty member at-large appointed by the University Senate, and the Head of CRCS or designee. “Human Subjects” include all individuals and groups from whom researchers anticipate gathering information or data necessary for the successful completion of the research design.
   The criteria for the University Review Board to approve research involving human subjects include:
   • Risks to participants are minimized;
   • Risks are reasonable in relation to anticipated benefits;
   • Selection of participants is equitable;
   • Informed consent is sought from each subject; and
   • Informed consent is appropriately documented.

   Sampoerna University is committed to protecting the safety, welfare, rights, and privacy of all persons who participate in research projects conducted by our faculty, staff, and students. It is also committed to ensuring that the participants of such research are fully aware of their rights and protections available to them. The following ethical principles, first articulated in the Belmont Report issued by the National Commission for the Protection of Human Subjects in 1979, are endorsed by Sampoerna University:

   • Respect for Persons—Respect for persons incorporates the following ethical convictions. Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to greater protection (i.e. prisoners, children, those who are mentally or cognitively disabled, or economically or educationally disadvantaged persons). Each person should be given the respect, time, and opportunity necessary to make his or her own decisions. A core feature of respect for persons is informed, voluntary consent. Prospective participants must be given the information they will need to decide to participate in a study or not to participate. Once provided with adequate information, the decision to enter a research project or not should be completely voluntary—free from undue influence or coercion.
   • Non maleficence and Beneficence—Persons are treated in an ethical manner by respecting their decisions and protecting them from harm. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do no harm and (2) maximize possible benefits while minimizing possible harms.
   • Justice—Justice is a difficult and complex ethical issue. Who ought to receive the benefits of research and bear its burdens is a question of justice in the sense of “fairness in distribution” or “what is deserved?” An injustice occurs when some burden is duly imposed or when some benefit to which a person is entitled is denied without good reason. Attempt at all times to distribute the risks and benefits fairly and without bias.
   Keep the principles of autonomy, beneficence, and justice in mind when you are selecting participants, excluding participants, obtaining consent, and conducting your study. The responsibility to protect and inform research participants is ultimately yours (all those engaged with research) and cannot be ignored or delegated. Although you may delegate various tasks to certain team members, you cannot delegate the responsibility of protecting and informing participants of their rights.
2. Informed Consent Procedures
   Informed consent is more than just a form; it is the basis of a dialogue between the researcher and research subject(s). Except under special conditions specified below (Waiving Informed Consent), researchers are required to obtain written informed consent from all adult participants.
   Researchers are required to provide prospective adult participants with sufficient information and opportunity to consider that information. Every consent form should obtain a statement of the participants’ rights.
   1. When the participants are under 18 years of age, parental (or guardian) consent must be obtained. Parents and guardians may sign a consent form giving permission for their child(ren) to participate in a series of projects conducted over a period of an academic year. Parent consent letters should provide information about the purpose of the research as well as information about the procedure itself from the child’s point of view. As with research involving adult participants, this letter should indicate how confidentiality would be maintained.
   2. Researchers may request a waiver of parental consent for students who are under the age of 18, but who are also matriculated students at Sampoerna University. The request and rationale for such a waiver should be clearly stated on the University Review Board application form.
   3. It is understood that although parental consent is obtained, child participants are free to decline invitations to participate without any penalty. Child participants should be given an age appropriate explanation about the procedures used and what to expect by way of participation. Children should be asked if they want to participate. Mere failure to object on the child participant’s part should not, in the absence of an affirmative response, be interpreted as assent. In the proposal, the researcher should indicate how assent would be obtained and documented.
3. 1. A statement that the study involves research, a readily understood explanation of the purpose(s) of the research, the expected duration of the subject’s participation, a brief description of the procedures to be followed, and identification of any procedures which are experimental.
   2. A description of any reasonably foreseeable risks or discomforts to the subject. These may include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience.
   3. A description of any benefits to the subject or to others that may reasonably be expected from research (if no direct benefit, this should be stated).
   4. A statement concerning costs or compensation to the subject, if any.
   5. An explanation of whom to contact for answers to pertinent questions about the research and the research subject’s rights, and whom to contact in the event of a research related injury to the subject. It is suggested that faculty include contact information for the Head of CRCS. Student researchers must include contact information for their faculty sponsor.
   6. Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained.
   7. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Compensation is separate from benefits and a distinction should be made here. If participants will not receive compensation under certain conditions, then an explanation of those terms and conditions should be provided.
   8. Signature of subject indicating agreement to participate and date of signature.Basic Elements of Informed Consent
4. 1. If the principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research;
   2. If the consent document is the only record linking the subject with the research;
   3. If the research involves no more than minimal risk to the subjects and involves procedures that do not require written consent when they are performed outside of a research setting; and
   4. The research could not be carried out in any other practical way. Waiving the Informed Consent Requirements. In some cases, written consent may not be required
   5. If there is no written consent form, an oral presentation of the research should be provided to the subjects by the researcher, with documentation that such a presentation was made to the subjects. In this instance, researchers should maintain a written summary of the oral presentation and some record that consent was provided by the participant. Researchers who believe their research project meets the requirements for a Waiver of Informed Consent should contact the Head of CRCS.

2.11.4 | Duration of Approval

1. All studies must be periodically reviewed again at least annually (if the duration of the research project extends beyond an academic year). There are times when the risks associated with a particular project are such that continuing review should take place more frequently. In these cases, the University Review Board will specify that the researcher report to the University Review Board at a shorter time interval (e.g. 3 or 6 months) or after a specified number of participants are enrolled. The researcher’s report must describe the observed effects of the research activities and/or how the participant(s) responded to the research interventions. The report will be made available to the University Review Board. The Chair will determine whether a full review by the Board is required to continue or suspend the research project.
2. Appealing a Decision by the University Review Board
   If the Board makes a decision that an investigator believes to be unfair, unsubstantiated, or unduly restrictive on his/her proposed research, the investigator should first discuss the matter with the Chair of the University Review Board. The investigator should be prepared to present reasons that he/she believes that the proposed research in in compliance with University policy and applicable laws related to the protection of human participants.
3. If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision, in writing, to the University Review Board. In developing his/her appeal, the investigator should document the claim that the proposed research is in compliance with University policy and applicable laws related to the protection of human participants.
4. The investigator must appear before the University Review Board to present his/her appeal and any supportive material or documentation obtained through consultation. Based upon this appeal, the University Review Board will issue a final determination on the proposed research. The University, acting through the Vice Rector for Academic Affairs, CAN overrule the University Review Board to disapprove a project, but CANNOT overrule the University Review Board to approve a project. Only the University Review Board can approve a project.
5. Negative decisions by the University Review Board may be appealed to the Vice Rector for Academic Affairs on the grounds of a failure by the Board to carry out a thorough and complete review in accordance with its stated procedures or on the grounds of a possible violation of the academic freedom of the investigator. Final appeal rests with the President.