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This document outlines several ethical dilemmas that may arise when conducting research, including issues around informed consent, protecting participant privacy and confidentiality, and treating vulnerable groups. Key principles discussed are the rights of participants to protection from exploitation, full disclosure of research details, fair treatment, and privacy. Procedures for obtaining informed consent such as disclosure of study goals and risks/benefits are also described. The document stresses obtaining consent from guardians for children or disabled individuals and ensuring voluntary participation from institutionalized or pregnant individuals.
This document outlines several ethical dilemmas that may arise when conducting research, including issues around informed consent, protecting participant privacy and confidentiality, and treating vulnerable groups. Key principles discussed are the rights of participants to protection from exploitation, full disclosure of research details, fair treatment, and privacy. Procedures for obtaining informed consent such as disclosure of study goals and risks/benefits are also described. The document stresses obtaining consent from guardians for children or disabled individuals and ensuring voluntary participation from institutionalized or pregnant individuals.
This document outlines several ethical dilemmas that may arise when conducting research, including issues around informed consent, protecting participant privacy and confidentiality, and treating vulnerable groups. Key principles discussed are the rights of participants to protection from exploitation, full disclosure of research details, fair treatment, and privacy. Procedures for obtaining informed consent such as disclosure of study goals and risks/benefits are also described. The document stresses obtaining consent from guardians for children or disabled individuals and ensuring voluntary participation from institutionalized or pregnant individuals.
a. A situation in which a difficult choice has to be Information on who is sponsoring or made between two courses of action, either of funding the study should be noted. If which entails transgressing a moral principle the research is part of an academic b. Are situations in which there is a choice to be requirement, this information should be made between two options, neither of which shared resolves the situation in an ethically acceptable g. Participant selection fashion Prospective participants should be told Ethical Principles how they were selected for recruitment 1. Right to protection from exploitation and how many people will be Researchers should not place participants at a participating disadvantage or expose them to damages h. Potential Risks [and Possible Benefits] 2. Right to full disclosure Prospective participants should be Researchers have explained the research study informed of any foreseeable risks fully and have described the subjects right to (physical, psychological, social, or refuse participation and discussed risks and economic) or discomforts and efforts benefits of participation that will be taken to minimize risks 3. Right to fair treatment Specific benefits to participants, if any, The equitable distribution of benefits and should be described, as well as possible burdens of research benefits to others Participant selection should be based on the i. Possible Benefits study requirements and not a group’s j. Alternatives vulnerability Participants should be told about 4. Right to Privacy alternative benefits or treatments that Researchers should ensure that their research is might be advantageous to them not more intrusive than it needs to be and the k. Compensation participants’ privacy is maintained continuously If stipend or reimbursements are to be paid, or if treatments are offered Procedures for Protecting Study Participants without a fee, these arrangements 1. Informed consent should be discussed Gaining an informed consent means that l. Confidentiality [Pledge] participants have adequate information about Participants should be assured that research, comprehend that information and their privacy will at all times be have the ability to consent to or decline protected. If anonymity is agreed, this participation should be stated Content of Informed Consent m. Voluntary consent a. Participant Status Researchers should indicate that Prospective participants need to participation is strictly voluntary and understand the distinction between that failure to volunteer will not result research and treatment in any penalty or loss of benefits They should also be informed that data n. Right to withdraw and withhold information they provide will be used for research Prospective participants should be told purposes that after consenting, they have the b. Study goals right to withdraw from the study or to The overall goals of the research should withhold any specific piece of be stated, in lay rather than technical information terms. The specific use in which the o. Contact information data will be put should be described Researchers should tell the participants c. Type of data whom they could contact in the event Prospective participants should be told of further questions, comments, or what type of data will be collected complaints d. Procedure Participants should be given a Documentation of Informed Consent description of the data collection a. Researchers usually document informed consent by procedures and of procedures to be having participants sign a consent form used in any innovative treatment b. The consent form should contain all the information e. Nature of the commitment essential to informed consent Participants should be told the c. Participants should have ample time to review the expected time commitment at each document before signing it point of contact and the number of d. The consent form should be signed by the contacts within a given time researcher and a copy should be retained by both parties ETHICAL DILEMMAS IN CONDUCTING RESEARCH
Confidentiality Procedures seldom expect to benefits personally from
a. Anonymity research The most secure means of protecting Researchers must also take steps to ensure that confidentiality occurs when the researcher healthcare and comfort for these participants cannot link participants to their data are not compromised b. Confidentiality in the absence of anonymity Special procedures may be done to obtain A promise of confidentiality is a pledge that any consent if they are physically or mentally- information participants provide will not be incapacitated publicly reported in a manner that identifies 4. Institutionalized People them, and will not be accessible to others They may feel pressure in participating because c. Certificates of Confidentiality they believe that treatment would be It protects participants in the forced disclosure jeopardized when failure to participate of research data in the whole range of Researchers need to emphasize the voluntary situations nature of participation Allows researchers to refuse to disclose 5. Pregnant Women identifying information on study participants in Safeguarding the pregnant woman, who may be any civil, criminal, administrative, or proceeding at heightened physical and psychological risk, at the federal state or local level and the fetus, who cannot give informed consent. Steps to Avoid Breach of Confidentiality 1. Obtain identifying information 2. Assign an identification (ID) number 3. Maintain identifying information in a locked file 4. Restrict access to identifying information to only a few people on a need-to-know basis 5. Enter no identifying information as quickly as practical 6. Make research personnel sign confidentiality pledges 7. Report research information in aggregate
Debriefing, Communication, and Referrals
a. Researchers can use format strategies to communicate respect and concern for participants’ well-being like debriefing sessions after data collection; it permits participants to ask questions or air complaints b. It is important when the data collection has been stressful or when ethical guideline had to be bent
Treatment of Vulnerable Groups
1. Children Legally do not have the competence to give informed consent, informed consent from the parents or guardian should be obtained It is appropriate to obtain assent id the child is at least seven years old If the child is mature enough (at least 12 years old) to understand basic informed consent, a written assent is available 2. Mentally or Emotionally Disabled Individuals whose disability make it impossible for them to weigh risks and benefits or participation by cognitive impairment, written consent should be obtained by a legal guardian To the extent possible, informed consent or written assent should be sought as a supplement 3. The Terminally-Ill Risks/benefits of the study for terminally-ill participants should be assessed since they