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Human Subjects Protections

Human Subjects Protections. Research Ethics. Basic Assumptions about How Research Should be Conducted. Subjects should be protected from harm. Subjects should have their identity protected. Subjects should be fully informed about the research study. Participation is voluntary.

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Human Subjects Protections

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  1. Human Subjects Protections Research Ethics

  2. Basic Assumptions about How Research Should be Conducted • Subjects should be protected from harm. • Subjects should have their identity protected. • Subjects should be fully informed about the research study. • Participation is voluntary. • Study procedures should show respect for cultural values and beliefs.

  3. Some studies can potentially harm participants. Consequently risks should be minimized. Potential harm can include: • Pain or physical danger. • Emotional arousal or stress • Intervention can produce long-term behavior or attitude changes • Intervention can cause embarrassment or social distress. • Intervention can involve misinformation or and manipulation. This should be minimize in order not to cause emotional distress.

  4. In order to make sure that participants are protected, all studies must be reviewed by human subjects/ethics review committee. Your projects must be reviewed by: • The agency in which your study will be conducted. • DSWE Human Subjects Committee • In rare cases, the University Human Subjects Committee may be asked to review your study if the department committee thinks that participants may be potentially harmed.

  5. Participants must give consent to participate. We are especially concerned about: • Children under 18 (consent must be obtained from parents). • Involuntary clients • Any participants likely to be vulnerable to coercion or undue influence.

  6. Components of Informed Consent Include: • Accurate explanation of evaluation procedures is made. • Respondent is given an explanation of risks and benefits • An offer is made to answer any additional questions about the project (contact information must be included) • The participant is told that he or she can withdraw at any time.

  7. Steps must be taken to protect participants from harm: • Confidentiality must be protected. We must not identify people who participate in the study. • If the study is likely to cause emotional arousal, we must make provisions to refer participants to a mental health professional for counseling.

  8. Methods for Protecting Confidentiality Include: • Responses must be anonymous (as feasible). • All information that can be attributed to individuals is kept confidential. (Responses to close-ended questions are summarized using statistics; fictional names are often used in qualitative analysis). • A coding system is used to track returned surveys or case records. However, the coding system should be kept in a secured location separate from the responses. • The responses are also kept in a secure location; only the researcher will have access. • Any instruments that could identify a respondent should be destroyed after data analysis if it can not be kept in a secure location. • Information about respondents should not be shared with agencies or supervisors.

  9. Methods used to verify consent to participate • Return of surveys implies consent (surveys should be distributed with letters that contains information about the study and human subjects protections). • Participation in phone interview implies consent. • Signed consent forms from participants (in some cases it may be sufficient to provide verbal information). • Public behavior (observations) generally does not require consent.

  10. Cover letters and consent forms should contain the following information: • A description of the purpose of the study. • An explanation as to how participants were selected. • A statement that participation is voluntary and that participants may withdraw at any time. • A description about procedures and what will be required from participants. • Emotionally sensitive issues that might be exposed and/or follow-up resources that are available if required. • A description of how information will be recorded if videotaping or audiotape is required. • A description of any discomforts and any known risks. • An explanation of who will have access to the data and information about the identity of respondents. • A description of how the data will be made public or of any other persons who may make use of the data • Contact information (for the researcher or the researcher’s institution) if the participant has any questions.

  11. Additional human subjects issues • Payment for participation (o.k. if everyone is paid). • Case record analysis requires that steps be taken to protect confidentiality of subjects and people described in the case record. • Withholding of treatment (in some instances it may be unethical to withhold treatment – for example, control groups). • Deception. (May be used in some cases where it will not cause undo harm or when authorities have been given permission).

  12. Ethical Issues in Qualitative Research • Researchers must state values and biases in writing reports. • Researchers must take steps to ensure that accurate accounts of participant perceptions are made (as feasible). • Researchers have a responsibility to use the data to enhance social change. • Consent is sometimes obtained through personal interaction with individuals or communities (entry). The researcher must establish trusting relationships. • Participants may be viewed as partners in the research process and always as the social equal of the researcher.

  13. Cultural Competency • Check to make sure that subjects can understand concepts described in survey or interview guide (pre-test). Are terms used that may have different meanings in different cultures. • Is the level of language appropriate to the participants? • Translations should be checked for accuracy and appropriateness of language to social class, age, and other demographic characteristics of participants (for example, formal versus informalSpanish). • Do study procedures violate any cultural norms (check with an informed source in the community).

  14. DSWE requirements for human subjects review • Submit pink human subjects forms to 292 instructor for the review process. • Submit your methodology chapter. • Submit a copy of your research instrument. • Submit a copy of cover letters and consent forms. • For secondary analysis, provide a detailed description of the data base to be used and how the data was originally obtained. (See human subjects procedures on course web page or department Blackboard).

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