In the context of this document, research is defined as any initiative that seeks to create original knowledge using scientific methodologies. Data collection within a service or organization should be preceded by formal authorization from the service or organization concerned. In cases where obtaining fully informed consent prior to participation could compromise the aims of the study due to the likely risk of limiting participants' responses and/or conduct, the guidelines on deception and withholding of information (paragraphs 3.28 to 3.30) should be applied.
If the confidentiality and/or anonymity of the data cannot be ensured, the participants must be informed of this possibility in the informed consent form. The participants must be given the opportunity to obtain information about the results and conclusions of the study (i.e. feedback). Respect for the dignity, safety and well-being of the participants should be among the most important considerations of any research.
Authorship should be determined by considering original and significant participation in the research, namely: significant contribution to research design, data collection and analysis, interpretation of results, discussion, writing and/or revising the manuscript. All authors must be fully responsible for the content of the publication, unless it is determined that their responsibility is limited to a certain part of the study and publication. Falsification consists of distorting, manipulating, removing or changing data, results or research materials.
GUIDELINE DOCUMENTS
SUBMISSION GUIDE FOR ETHICAL APPROVAL AT ISCTE-IUL
According to the elements of the study, it will be eligible for automatic approval or approval by deliberation (see Diagram of submission and ethical approval). However, regardless of the type of approval, the submission process is the same for all studies. Researchers should pay attention to the possible existence of specific requirements, for example in terms of data collection/storage in certain circumstances (e.g. internal process of authorization in school or hospital contexts), or under public competitions to obtain funding (e.g. .internal process of review and approval of the actual funding agency).
Obtaining ethical approval from ISCTE-IUL does not waive or replace compliance with this type of requirement, nor any other legal/administrative obligations that may apply to the research. Under the provisions of the Regulation of the Ethics Committee of ISCTE-IUL (Order number 7095/2011 published in Diário da Repú blica, 2nd series, number 90, dated 10 May 2011), the Ethics Committee of ISCTE-IUL is responsible for the assessment and approval of the study plans submitted. Ensure that the study is in accordance with the provisions of the Research Ethics Code.
Complete the Ethics Approval Submission Form with information on the following aspects: Description of the study; Attendees; Informed consent and debriefing; Protection and safety of the participants; Statement of Responsibility and Ethical Conduct;. Include the applicable attachments requested in the form (i.e. informed consent; debriefing; questionnaires/materials of the study) and send the submission to the address: [email protected]. In accordance with the criteria presented in the chart, which will be reviewed by a member of the ISCTE-IUL Ethics Committee, approval is automatic and performed within a desired maximum time limit of fifteen business days.
Subject to approval with review by the ISCTE-IUL Ethics Committee, the study plan is submitted prior to commencement of data collection and is subject to evaluation and review by the Committee. Significant risks to participants (code of conduct: 3.25 and 3.26) Sample drawn from vulnerable population (code of conduct: 3.27).
TOOLS AND PRACTICAL MODLES
S UBMISSION F ORM FOR E THICAL A PPROVAL
People who are dependent on those responsible for the research (e.g. leaders; power/status asymmetries) or in the context where the research takes place (e.g. university, companies). State the research problem and significance of the study and explain the original contribution it makes to the advancement of knowledge and/or other expected benefits to individuals or communities. Explain the choice of research methods and describe all data collection and recording procedures, participants' participation and tasks, interventions implemented, duration of participation and frequency of data collection.
Identification of the study and principal investigator(s) ☐ Description of the general aim of the study, number of sessions, estimated. time and general features of the participation. The voluntary nature of the collaboration, which includes the option to stop. the participation at any time without requiring justification ☐ Information about any risks, discomfort or other negative effects associated with. Document/text presented to the participant at the end of the participation ☐ Oral explanation given to the participant at the end of the participation.
More specific information about the study research objectives, hypotheses, procedures and/or expected contributions, if applicable. If you wish to clarify or justify any aspect related to the elements of the informed consent and/or debriefing, please provide a description. When submitting the submission, please include the informed consent and debriefing documents/texts, or in the case of an oral explanation, the transcript of the direct speech).
People in unequal or dependent relationships with those responsible for the research, or in the context in which the research takes place; Indicate the procedures foreseen to minimize the risks and/or monitor the safety of the participants. I have (individually or in the team) the necessary competencies and resources to complete the project in the manner presented in this entry; ☐ My conduct and decisions in all matters related to this project will take into account the provisions of the Code of Ethical Conduct in Research – ISCTE-IUL.
There are no expected significant risks associated with participation in the study [or, if there are, inform participants of the risks]. Completing the questionnaire presupposes that you have understood and accept the conditions of the present study by consenting to participate.]. In connection with your participation, [disclose elements of deception or concealment of information when applicable; identify/provide the planned measures to deal with any negative consequences for the participants, when relevant].
Please note that the following contact information may be used for any questions you may have, comments to share, or to express your interest in receiving information about the main results and conclusions of the study: [insert member's name and email( -ov) teams or coordination].
SUGGESTED ACTIVITIES
Suggestions for training, teaching and capacity-building activities towards research ethics at ISCTE-IUL
GENERAL RECOMMENDATIONS
- Guiding principles of the constitution and activity of the ethics committee The contribution, relevance and centrality of the ethics committee in the context of
- Training and competences of persons with responsibility in research issues The training and development of competences of persons with responsibility in
Guiding principles of the establishment and operation of the Ethics Committee The contribution, relevance and centrality of the Ethics Committee in the context of The contribution, relevance and centrality of the Ethics Committee in the context of research conducted in the academic sphere depends on one largely on the construction of a culture and organizational structure that unambiguously positions ethics as a fundamental part of the research process. In this context, five guiding principles are identified as key elements of the establishment and activity of the Ethics Committee: i) independence; ii) capacity building; iii) diligence; iv) Transparency; and v) Competence. The institutional decision-making structures are responsible for providing the necessary resources for achieving these principles and promoting their monitoring, in the perspective of continuous improvement of the systems and procedures of ethical approval in research.
The principle of independence emphasizes the need to prevent conflicts of interest in the activities developed in the field of research, the ethics committee and the organizational structures of the institution. To this end, the members of the ethics committee refrain from participating in deliberations that may have direct implications in other roles that these members play in connection with the research (e.g. evaluation of study proposals in which they are involved). Likewise, the members of the ethics committee determine their conduct, decisions and recommendations according to strict criteria that give value to ethics in research, regardless of other needs, interests or expectations that may exist at the institutional level.
The principle of capacity building calls for the responsibility of the ethics committee in actively promoting education, information and support of the research participants for the planning and conduct of studies in an ethical form. In other words, this principle entails the responsibility of the committee to affirm itself as the driver of capacity building of the academic community on relevant research ethics issues (e.g. the capacity building principle also emphasizes the importance of the committee in providing constructive and instructive responses in its opinions on submissions for ethical clearance, outlining guidelines for resolving any limitations it may discover.
The principle of competence refers to the general constitutional lines of the ethics committee and working groups designated for the assessment of submissions for ethical approval (through deliberation), in order to ensure the necessary aptitude and qualifications for the performance of the respective duties. The topic relating to Ethical Approaches seeks to promote familiarity with some of the main models of normative ethical consideration and their application in the Western context. The topic relating to Reference Codes and Principles of Ethics in Research aims to promote familiarity with the historically most relevant models of ethical application in the context of research.
The content of this topic may include: Informed consent; Confidentiality and management of information; Relevance of research; Protection of the participants; Integrity and truth in research. The subject related to Ethics in research – capacity building and practical guidelines aims to promote and apply skills in ethical reasoning, anticipation, decision-making and resolution of dilemmas, prepare submissions for ethical approval and respond to requests in the context of the review process.
SPECIFIC RECOMMENDATIONS
The content of this topic may include: Identifying issues of importance in research ethics; Solving an ethical dilemma in the context of research; Obtaining ethical approval in the context of research; Dealing with unexpected ethical challenges in the context of research;
