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Policy & Procedure
Policy Title :
Research Integrity, Ethics and Misconduct
Policy Number :
V. 1
Responsible Party :
Research
Effective Date :
05/12/2013
Revised Date :
_______________________

Purpose

The purpose of this policy and its procedures is to enforce the responsible ethical conduct of research among research faculty of Prince Mohammad Bin Fahd University (PMU), as it pertains to the use of human and animal subjects, while ensuring research integrity and discouraging misconduct and questionable research practices.

Statement :

Prince Mohammad Bin Fahd University (PMU) aims to become a top research-oriented comprehensive university in the Kingdom of Saudi Arabia and the region.  As such, the University expects the highest standards in the conduct of all those involved in research in its name, including faculty members, staff, students, visiting scholars, emeritus professors, or anyone affiliated to its research centers and groups including consultants and contractors. Furthermore, PMU has an obligation to the wider research community, current and potential funders/donors and to the Saudi society as a whole to uphold the ethics and integrity of academic research at all times. 

The research ethics definition adopted by PMU refers to the proper and scholarly manner in which the entire research process is handled, particularly when it involves human and/or animal subjects. Therefore, the project planning phase, data collection, reporting of research findings, and the ultimate submission of a manuscript for peer review, has to adhere to the highest scholarly standards and norms and keep the well-being of its human or animal subjects at the centre. In other words, research ethics is intended to include the fostering of research that protects the interests of the public, the subjects of research, and the researchers themselves. Research is a public trust that must be ethically conducted, trustworthy, and socially responsible if the results are to be valuable.

PMU principles in research ethics are aligned with those of the Nuremberg Code of 1947. The university has thus embraced and adopted these principles while keeping them focused on its main research areas. The Nuremberg Code was adopted in 1947 in Germany (city of Nuremberg). The motive behind the development of the ethics code was primarily to protect human subjects involved in research experiments/studies, particularly in medical research. This is also emphasized in each of the ten principles of the Nuremberg Code, the premise of which is the very first principle stating that:

“The voluntary consent of the human subject is absolutely essential”.

Other influential documents in the history of research ethics that were considered in shaping this PMU research ethics policy are the Helsinki Declaration titled “Ethical principles for medical research involving human subjects” (1964), and the Belmont Report titled “Ethical principles and guidelines for the protection of human subjects of research” (1979). 

Human subjects in research

Prior to the publication of the Nuremberg Code and subsequent publications on the subject of ethics, experiments were conducted on humans without their consent, and without much concern for their rights, welfare or potential harm that the experiment would cause. PMU is committed to developing, implementing and maintaining a systematic and comprehensive appropriate leadership and monitoring of any research involving human subjects, and has set the following standards in this regard:

  • The Principal Investigator (PI) must have appropriate expertise and training
  • There must be scientific or scholarly merit in the project
  • The PI and those involved in the study must be trained and educated with regards to all aspects of research  involving human subjects, and accept continuing responsibility for compliance with this policy through the research process.

Accountability in research involving human subjects

The overall responsibility for ensuring compliance in research involving human subjects lies with the Principal Investigator.

At the institutional level (the University), the responsibility lies with the Dean of Research Development, who is the designated “Institutional Official” (IO). The Institutional Official will be responsible for ensuring that the importance of protecting human subjects is properly understood within the University research community.  When an Internal Review Board (IRB) is formed, the IO is responsible for overseeing the Board and monitoring its ability to act with regard to all research involving human subjects. The IO will appoint the Chair of the IRB as well as a Chairman of the Research Ethics Committee (REC) to monitor and approve all research on human subjects at PMU. Until these positions are established the IO assumes their respective responsibilities.

The Chairman of REC will develop and implement policies as well as internal training programs for persons engaged in research involving human subjects. He/she will also be responsible for reporting non-compliance, ensuring that there are appropriate means for participants to report questions or concerns about research in which they are participating, and that any such questions or concerns are responded to promptly and appropriately. He/she will promote human subjects protection throughout the university as well as communication and cooperation between investigators and faculty.

The Internal Review Board (IRB), on the other hand, will be responsible for reviewing all proposals on research involving human subjects, thus ensuring that all proposals meet the applicable ethical standards of this policy.

Research proposals submitted to the IRB must contain sufficient information to allow reviewers to determine the potential risks to the subjects.

Projects that meet the criteria for exemption (outlined below) do not require approval by the IRB.  The IRB may make any of the following decision on the proposals: approved with modifications, closing, suspending, terminating or disapproving research proposals. 

The IRB will advise the Chairman of REC and the IO of any serious or continuing noncompliance with research on human subjects.  If a member of the IRB is proposing research involving human subjects, he/she may not participate in the meeting to review their own proposal. Meetings of the IRB must only take place when a quorum is present.  Quorum will be defined as one more than half the number of IRB members.

Some projects, although involving human subjects, may be exempted from going through the ethical clearance process. However, a non-exempt university form must be filled out and submitted to the IRB office. The exemption eligibility includes:

  • All research where participants are 18 years of age or older.
  • Research that is to be conducted in an established or commonly accepted educational setting  (including but not limited to schools and universities), involving normal education practices (including but not limited to instructional strategies, effectiveness of or the comparison among instructional techniques, curricula or classroom management methods).
  • Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior.
  • Research involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens
  • Research aimed at studying, evaluating, or examining public benefit or service programs.
  • Research involving taste and food quality evaluation or consumer acceptance studies.

The basic ethical guidelines in research involving human subjects include:

  • Respect for the persons involved in the study as subjects
  • Ensuring that the benefits of the study far outweigh the possible harm to the subjects.
  • Proper documentation of signed consent approved by the IRB.
  • In the case of the informed consent being waived, for example in studies involving minimal risk to the human subjects, the rights and welfare of the subjects must still be protected.

In terms of the PMU policy, research on human subjects also includes three specific groups:

  • University students participating in research,
  • Women as subjects in research, and
  • External human volunteers

University students participating in research

Student participation is an integral part of some research projects, for example in research on teaching methods, curricula and other areas related to the scholarship of teaching and learning. It is also common practice to award extra study credits to students who participate in a project, such as in the social and behavioral sciences. In cases where credits are awarded, there should also be alternative assignments offered to students who declined to participate in a study, allowing them to also accumulate the same amount of credits as those participating. Participation in any such project must be voluntary and students must be provided with accurate information before commencing with the study. Furthermore, Principal Investigators must not influence or coerce students into participating in a study, and those who decline participating must not be victimized.

The  following guiding principles must be observed when working with students as subjects:

  • Students must be at least 18 years of age or older so that they can give consent for themselves
  • Researchers may not access student records without prior written consent from the student
  • Since there are risks of confidentiality in the close environment of the university, special attention should be given to full disclosure of these risks when obtaining the student’s consent to participate
  • Students must be allowed to withdraw from the study at any time
  • If the research is one where data collected from a group project or perhaps an audio or video tape of the group activity each student’s consent is necessary for the use of the data in research
  • Students have the right to full disclosure as soon as possible.  Whenever possible the debriefing should be used as a teaching opportunity.

General accountability procedures/channels followed in research involving human subjects at PMU will be followed in all research involving university students as participants.

Women as subjects in research

PMU supports and promotes the participation of women/females as subjects in all research areas, provided that such participation is voluntary and the research leader guarantees the ethical and professional treatment of women in all the research processes. Studies involving women as subjects must follow and observe all the rules, regulations and laws of the University and the Kingdom of Saudi Arabia. In the event that there is conflict or variation in the rules, regulations and laws of the University and the Kingdom, those of the Kingdom of Saudi Arabia will prevail.

The review process of all studies involving women as subjects will be the responsibility of the Institutional Human Subject Review Board.

The principal investigator will submit, along with the application, consent forms signed by all women participating in the study to the Institutional Human Subject Review Board. Upon assessing the proposals, the Board will make a recommendation to the University Research Council – the structure responsible for making a final decision on the use of women as subjects in research, as per university policy.

University Research Council may appoint a subcommittee to review specific studies related to women as subjects, namely the Women Research Review Council.

The Women Research Review Council shall review all proposals where women are participating or used as subjects of the study, and will do so following the procedures established by the Institutional Human Subject Review Board and the Exempt and Non-Exempt policy of PMU. The Review Council has the mandate to recommend approval, modification, or rejection of women participation in research studies.

Broadly, the Women Research Review Council will be responsible for assessing ethical and legal issues related to female students who are participating in research studies as subjects, while the Institutional Human Subject Review Board is responsible for judging the technicality and overall quality and scientific merit of the research proposal involving women as subjects of study.

All research involving women must be in accordance with the social and traditional norms of the Kingdom of Saudi Arabia.

External human volunteers in research studies 

External human subjects may be used as volunteers in research studies conducted by PMU faculty. These studies will abide by the ethical guidelines followed in all studies involving human as subjects.  Furthermore, the study will observe all the rules, regulations, laws and customs of the University and the Kingdom of Saudi Arabia. In the event that there is conflict or variation in the rules, regulations and laws of the University and the Kingdom, those of the Kingdom of Saudi Arabia will prevail.

The Principal Investigator planning to involve external volunteers as subjects in his/her study must submit an application form, accompanied by signed consent forms, to the Institutional Human Subject Review Board requesting permission to this effect.

The final decision on the approval or disapproval of using external volunteers as subjects in research will be made by the University Research Council, after taking into consideration the recommendation(s) of the Institutional Human Subject Review Board.

University Research Council may appoint a subcommittee to review specific studies related to women as subjects, namely the Human Subject as Volunteer Research Review Council. This Council shall review proposals involving external volunteers as subjects, and their participation in research studies. It will do so in line with the procedures established by the Institutional Human Subject Review Board and the Exempt and Non-Exempt policy of PMU. Council may also recommend approval, modification, or rejection of external volunteer participation in research projects.

The Human Subject as Volunteer Research Review Council will be responsible for assessing ethical and legal issues related to external K-12, college, and/or university students who are participating in research studies as subjects; while the Institutional Human Subject Review Board remains responsible for judging the technicality and overall quality and scientific merit of the research proposal involving external volunteers as subjects of study.

Training in the protection of human subjects in research

PMU is highly committed to the development of a strong institutional research agenda that will allow the University to ensure quality and excellence in research. The University, through its administrative units of the Deanship of Research Development, the University Research Council and the Institutional Human Subject Review Board, will facilitate the training and development of all faculty and staff involved in conducting research that includes the use of human subjects. The University Research Council and the Institutional Human Subject Review Board will be responsible for ensuring that researchers are trained on how to ensure ethical and professional treatment of the human subjects before, during, and after their research processes.

Researchers, whether working as individuals or in groups, must attend a training session designed, organized, and delivered by the Institutional Human Subject Review Board before submitting the final research project application, and before approval by the Board.

The Training and Development Areas of PMU are as follows:

  • In accordance with any university research policy related to the use of human subjects in any type of research study, the University Research Council and the Institutional Human Subjects Review Board will join efforts to provide training and development in the areas of Women as Subjects, External Volunteers as Subjects, Student Participating in Research, and any topic that relates to the importance and protection of human subjects in research.
  • The design, organization, coordination and delivery will be the sole responsibility of the Institutional Human Subject Review Board.
  • The training plan and topics will be known by the University Research Council that will recommend for approval and execution.
  • The training timetable will be decided upon by the Institutional Human Subject Review Board.
  • Training will happen twice a year during regular academic semester.
  • Dates of the trainings will be announced at the beginning of each academic semester
  • The trainer(s) will be selected by the Institutional Human Subject Review Board and may be an internal or external professional researcher or a member of the Institutional Human Subject Review Board.

A Certificate of Attendance will be awarded to each researcher who attended the training course for a minimum of four (4) face-to-face hours. It will indicate the topic, number of hours attended, and date of delivery.

The certificate will provide proof that the individual researcher has actively engaged and participated in a training session that is geared to support and protect the use of human subjects in any type of research study.

Research involving animals

Similarly, ethics in research involving animals has also received attention from researchers and the general public for many years. Animals are often used in experiments where the results will be applied to humans, for example in testing new drugs and treatments for diseases affecting humans. Animal rights groups and concerned members of the public in many parts of the world argue that conducting research using animals is a cruel act and should be stopped, whereas the scientists involved in such work argue and believe that the research is necessary. There are several factors that researchers working with/on animals have to take into consideration during the execution of the study. These include:

  • Ensuring that approval has been obtained from the relevant regulatory structures, and that the protocol to be used is reviewed and approved before commencing with the study.
  • Researchers must prove to the relevant bodies that there are no other alternative ways to conducting the study without using animals.
  • The benefits (to human health) of using animals must far outweigh the negatives (the effect on animals).
  • The findings of the study must have benefits to the area of work in the long term, particularly for humans and animals, beyond the current study.
  • Ensure minimal harm and suffering to the animals.
  • Other researchers must be able to replicate the study at a later stage.

While the issue of research ethics remains a strong focus in studies involving experiments on human and/or animal subjects, it has also extended to other study disciplines that involve humans in research in different ways, such as the social sciences and humanities. For example, “voluntary consent” is also essential in studies where humans will be interviewed as a form of data collection, and where focus group discussions will be conducted. The protection of confidentiality of participants is also very important.

Policy focus

This policy articulates the procedures to be followed by PMU in dealing with unethical practices in research, as well as the mechanisms to be employed for impartial fact-finding and fair adjudication of any allegations in this area. A framework of principles and standards has therefore been formulated to help identify and address such ethical issues.

The main concern of this policy is quality of the research process – maintaining the highest standards of integrity, impartiality and respect for data is essential. The university places great emphasis in that a risk assessment approach is done to safeguard the physical and psychological wellbeing of participants and researchers in all affected studies.

The relationship between PMU research agenda and the broader social and physical world (both present and future) is critical. Furthermore, social relationship within the world of research that includes collegiality, protection of human subjects, animal welfare, and institutional integrity, is of utmost importance.

This Research Ethics policy does not relieve PMU employees from their responsibilities to comply with professional ethics guidelines, applicable national laws and/or regulations of the KSA, other university statutes, rules and policies. The policy shall be administered in compliance with the laws and regulations of any agency sponsoring and funding the research in question.

Research Ethics policy has strong links to two other policies that are critical in the regulation of research activities, namely: Research integrity, and Misconduct in research, discussed in subsequent sections of this document.

Research integrity

Research integrity at PMU refers to high quality and robust practice across the full research process of planning, conducting and implementing research, recording and reporting of results, and the dissemination, application and exploitation of findings.

Research integrity actively adheres to the ethical principles and professional standards essential for the responsible practice of research. The adoption of the principles and practices must become a personal credo rather than impositions by policymakers. Research integrity therefore starts with the individual researcher. Good research practices and conduct include, but is not limited to:

  • Intellectual rectitude in designing, planning, proposing, performing and reporting research.
  • Precision in measuring individual contributions to research proposals and reports
  • Impartiality and objectivity in peer review
  • Collegiality in academic and research exchanges, including communications and sharing of resources
  • Transparency in conflicts of interest or potential conflicts of interest
  • Protection of human participants in the conduct of research
  • Humane care of animals in the conduct of research
  • Adherence to the mutual responsibilities between investigators and their research participants

Quality and commitment throughout all stages of research is critical in maintaining research integrity. The qualities in this regard can be described as:

  • Creating a culture of honesty and  integrity
  • Striving for excellence in research to produce and disseminate high quality work
  • Allowing openness to scrutiny and debate research methods and results
  • Promoting good and rigorous research practice
  • Recognizing accountability and responsibility as key elements of a researcher work
  • Emphasizing care and respect, the researcher should ensure the dignity, rights, safety and wellbeing of all involved in research

Researchers must show a commitment to ensuring research integrity through:

  • Meticulous recording and retention of research data
  • Publishing and disseminating research accurately and responsibly
  • Adhering to all legal and ethical requirements and guidelines produced by appropriate bodies
  • Safeguarding own interests, those of the University and those of any funder or collaborating body in relation to intellectual property
  • Identifying, declaring, and addressing any conflict of interest, whether actual or potential, as soon as they become apparent
  • Fostering the open exchange of ideas and ensuring robust management practices to safeguard the honesty and integrity of the research conducted, and

Being constantly trained and developed to attain the necessary research skills for future role and career development.

Misconduct in research

Research misconduct occurs when a researcher intentionally includes falsified/manipulated data in his/her research report, and/or uses other people’s work without acknowledgement and proper referencing (plagiarism). Fraudulent activities also form part of misconduct in research. Another act of misconduct occurs when an individual excludes data or information from the research report so that the study can show a pre-conceived conclusion. In general, any deviations from the standard practice in the main research steps such as proposal writing, methodology, the review of research report etc. may constitute misconduct. PMU is committed to the highest standards of research integrity and takes very seriously any concerns raised about the conduct of research undertaken by any of its faculty, staff or students.

In addition to actions of research misconduct mentioned in the previous paragraph, there are many others including but not limited to:

  1. Failure to obtain ethical clearance, where relevant, prior to commencing with the research.
  2. Disclosing participants’ information, including personal details, without their consent.
  3. Claiming, for example, that a manuscript was peer-reviewed prior to publication, when in fact it was not reviewed.
  4. Paying individuals to participate in a research project (thus bribing participants).
  5. Inappropriate use of research funds and inaccurate reporting of expenditure.
  6. Deliberate misinterpretation of research findings.
  7. Using false credentials and related information.
  8. Intentionally delaying the publication of results to pursue a personal agenda.
  9. Complete deviation from what the researcher had proposed to do in the research proposal, without a valid justification for the change and without following the correct channels prior to changing the research direction.

Procedure for dealing with reported cases of misconduct in research

The relevant university structures (discussed later in this policy) will ensure that any claims or reports of misconduct among its faculty, staff, and students are not ignored but dealt with accordingly. An extensive investigation will be conducted following a claim to ensure that individuals do not fall victims of false and malicious allegations. To conclude that an act of research misconduct occurred, there should be evidence that:

  1. The researcher significantly violated or departed from accepted practices of the relevant discipline.
  2. The researcher was aware that his/her act constitutes misconduct and that the action(s) was intentional.
  3. Valid evidence was presented to the relevant office by the complainant.

The University encourages all its faculty, staff, and students to report any acts of misconduct to their relevant College head or the Dean of Research Development. This should be done anonymously in writing, and evidence of misconduct must be included. Individuals who come forward and report misconduct will not be penalized or victimized, and their details will be kept confidential in cases where these have been disclosed to the reporting office. In cases where the misconduct was done by a non-PMU partner, for example a funding agency, business partner, or government official, the university will address the issue with the affected party.

Disciplinary actions will be taken against any person found to have made false allegations against other colleagues.

Implementation

This Policy will be interpreted and implemented in a manner that is consistent with the vision and mission of Prince Muhammad Bin Fahd University as a research community committed to the principles of honesty, trust and collegiality and to the idea that fair play must prevail at all times.

It applies to all individuals who conduct research at PMU, and those at affiliated institutions who submit research proposals to the PMU research ethics review system. Conducting research at PMU means research work undertaken by PMU faculty, staff and students and by all persons who use PMU facilities for the creation, dissemination and publication of research work. The policy applies to both funded and unfunded research activities.

Some of the provisions of this policy deal with matters that are also treated in other guidelines and regulatory documents of PMU. Where appropriate, reference should be made to these guidelines and documents.

Roles and Responsibilities

University Research Council (URC)

The University Research Council, chaired by the Vice-Rector of Academic Affairs, is the body responsible for developing, coordinating and ensuring the implementation of the University’s policies and procedures for the ethical conduct of research.

The URC may pursue registration or accreditation of the Research Ethics Committee members with external agencies, as appropriate and valuable.

It must also recognize the level of commitment required for the Research Ethics Committee service and will take this into account before the Scientific Council of PMU in decisions relating to assessment, promotion and distribution of workload.

Research Ethics Committee (REC)

Members of the Research Ethics Committee will be appointed by the University Research Council. The Committee will consist of the following persons:

  • The Chairs of the male and female sections of the University
  • A faculty representative of each campus
  • The PMU legal counselor
  • The Dean of Research Development
  • Two external community representatives not affiliated with PMU.

The REC may draw upon additional members, as may be necessary for it to effectively fulfill its responsibilities.

The main responsibilities of REC are to:

  • Develop and review policies, guidelines and procedures relating to research ethics at PMU.
  • Respond to issues raised by colleges and to audit and provide general guidance to the Campus Committees.
  • Promote training in ethics in research at PMU.
  • Provide assurance of the ethical conduct of research at PMU, particularly that involving human and animal subjects.
  • Serve as the Final Appeal Committee on research ethics disputes for all
  • Campuses.
  • Report to the University Research Council on the ethical conduct of research at PMU.

The Committee will meet at least twice per year. The Chairman may act on behalf of the Committee between meetings, but will provide a report on any actions taken to the rest of the Committee at the next meeting.

Steps to follow when reporting unethical practices and misconduct

Research Ethics Committee (REC) involvement

The Research Ethics Committee is authorized to take corrective action, including the rescinding of approval of a research project, in the event that any allegation of misconduct in research is upheld.

REC will invite any member of the University community who has information related to potential research misconduct to report such information to the committee. It is expected that the member of the community shall cooperate with REC in the review of allegations and the conduct of inquiries and investigations.

The Research Ethics Committee will act promptly within 15 calendar days. Within that period, the Committee will interview the main players and witnesses and will gather data beyond any that may have submitted by the relevant college.

REC will bring the case to the attention of the University Research Council, and Council shall decide whether there is sufficient evidence to warrant an inquiry.

The Research Ethics Committee shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, against whom no finding of research misconduct is made.

University Research Council (URC) involvement

The University Research Council (URC) will be informed by the REC about the case under investigation.

Council will verify whether the complaint falls within the definition of research misconduct as per policy, whether the information provided is credible, and whether it is sufficiently specific to enable potential evidence of research misconduct to be identified.

URC shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in Research Misconduct, against whom no finding of research misconduct is made.

The University Research Council shall ensure that institutional members and or upper level university administration may not retaliate in any way against complainants, witnesses, or other participants in the investigation.

After confirming allegations of research misconduct, URC may take actions deemed necessary to (a) protect the research subjects; (b) protect the interests of faculty, staff, and students; (c) preserve evidence, (d) protect University resources, and/or (e) comply with applicable KSA laws and/or regulations.

URC may take an action to impose minimal burdens on the affected people in the case, to the extent reasonable and practical, and to comply with applicable University Statuses, General Rules and other regulatory policies applicable to the University.

If any evidence of criminal conduct is discovered during the investigation, the University Research Council may notify and present the case and allegations to the University Legal Counsel.