Week 2 Day 3 Ethics in Research DIE 4564 Research Methods Ex-Pharmaceutical Rep:Billions Spent on Drug Ads

Ethics: (eth/iks) →The study of standards of conduct and moral judgment. →The rules or standards governing the conduct of a person or the members of a profession.

Ethical Principles Three main principles in biomedical research ethics: Beneficence  Includes equipoise Autonomy  Includes “respect for persons” Distributive justice

Definitions Beneficence (do good) and nonmaleficence (do not harm): researchers must balance the likely benefits and risks of the study  Equipoise: experimental research should be conducted only when there is genuine uncertainty about which treatment will work better Autonomy: Voluntary participation with informed consent Distributive justice: infers that the source population must be an appropriate and non-exploitative one

Examples of Ethical Issues to Consider When Planning an Experimental Study

Cultural Considerations A protocol must be appropriate to the culture or cultures of the expected study participants.  Recruiting  Informed consent process  Survey instruments  Data collection process What other cultural consideration might be included?

Issues with beneficence…. Beneficence = the study should do good Individual participants and/or the communities from which they are drawn should benefit from the study Nonmaleficence = the study should do no harm Participants should never be injured (physically, mentally, emotionally, socially, psychologically). Steps be taken to minimize all potential sources for harm

Respect for persons … Respect is a broader concept that includes… Justifying the necessity for the research project. Choosing an appropriate source population. Using a fair process to sample & recruit. Making research procedures minimally invasive. Maintaining the confidentiality of study data. What else would you expect “respect” to include?

Issues with autonomy and respect  Participants must volunteer for a study without being unduly influenced by the prospect of being compensated for their participation  Participants must be able to understand what it means to be a research subject, including the possibility of being assigned to a control group instead of the new intervention

Ethical implications of incentives Participation in a research project should not be an undue burden to participants, but incentives must be balanced with the need for voluntary participation. What are the implications of offering incentives such as:  Inducements to encourage participation  Reimbursement for the costs of participation  Compensation for their time and efforts

Voluntariness When an individual feels coerced into participation, the principle of voluntariness is violated.  Coercion could include social pressure or requests from authority figures.  Coercion can also include overly generous incentives. Researchers have to be very transparent about what participants will gain from participation in a research study and what they will not gain.

Vulnerable Populations Most members of vulnerable populations can make their own decision about whether to participate in a research project. For children and some adults with cognitive impairments, a legally approved guardian is allowed to grant consent on behalf of the study participant. Whenever possible, in addition to having the legal representative’s consent, potential participants should assent to their own participation.

Informed Consent Statements Informed consent statements provide essential information about research projects to potential research participants so that they can make a reasoned decision about whether to enroll in a study.  What is involved  Potential benefits  Potential burdens  Plans for use of the data collected

Content for an Informed Consent Statement

Informed Consent Statements The statement should use clear, simple language that the reader is able to understand. Cultural and linguistical diversity issues need to be addressed.

Informed Consent Process The informed consent process consists of these steps: 1. Reading the informed consent statement to a potential participant and/or allowing the individual to read a copy of the statement. 2. Allowing adequate time for the potential participant to consider whether he or she wants to participate. 3. Answering any questions. 4. Only then asking whether the individual is willing to sign an informed consent form.

Informed Consent Documentation For most studies, the expectation is that each study participant will sign a printed copy of the informed consent statement. In some situations, oral consent may be more appropriate. In a limited number of studies, the individual informed consent process may not be required.

Anonymity v Confidentiality  Anonymity – guaranteed in a research project when neither the researchers nor the readers of the findings can identify a given response with a given respondent.  Confidentiality – guaranteed when the researcher can identify a given person’s responses but promises not to do so publicly.

Confidentiality When possible, do not collect any personally identifiable information. When individually-identifying information must be collected, many steps throughout the research process should be taken to protect the information. Researchers asking questions about sensitive issues must decide ahead of time how to handle disclosures.

Distributive Justice Distributive justice seeks to ensure that the benefits and burdens of research are equitable.  Discussion point: How might the perception of distributive justice be an area of controversy?

Ethical Issues in Social Research Deception  Deception within social research needs to be justified by scientific or administrative concerns.  Debriefing – interviewing subjects to learn about their experience of participation in the project.

Ethical Issues in Social Research Analysis and Reporting  Ethical obligation to colleagues in the scientific community.  All results must be reported (positive and negative).  All limitations must be admitted.

Two Ethical Controversies Trouble in the Tearoom: Laud Humphreys ( )  Studied homosexual activities in public restrooms in parks  Researcher became interested in the lives of participants  Researcher volunteered to become “watchqueen”  Researcher collected personal information about the participants (license numbers of cars) Which ethical issues are in question?

Two Ethical Controversies Observing Human Obedience: Stanley Milgram ( )  Participants imitated a laboratory-based World War II controversy  Participants were assigned job of “teacher” – to teach a list of works to the “pupil.” If the pupil got the word wrong, the teacher would administer increasing levels of shocks to the pupil. Which ethical issues are in question?

The Politics of Social Research Politics in Perspective 1. Science is not untouched by politics. 2. Science does proceed in the midst of political controversy and hostility. 3. An awareness of ideological considerations enriches the study and practice of social research methods. 4. Whereas researchers should not let their own values interfere with the quality and honesty of the research, this does not mean that researchers cannot or should not participate in public debates.

Considerations (8 Cs) in Research Ethics

Ethics Review Boards The three primary goals of research ethics committees (RECs), or Institutional Review Boards (IRBs), are: To protect the “human subjects” who participate in research studies. To legally protect the researcher’s institution from the liability that could occur as a result of research activities. To protect researchers by preventing them from engaging in activities that could cause harm.

Ethics Committee Responsibilities The major functions of ethics review boards are to: Review new and revised research protocols. Approve or disapprove of those protocols. Ensure that informed consent is documented, if required. Conduct continuing review of long-term research projects.

Warning! Ethics review can take a long time! The IRB/REC application should be submitted to the ethics committee as soon as possible in the planning process.

Application Materials Some research ethics committees ask applicants to provide a narrative research statement that addresses a list of possible ethical concerns. Others require the completion of dozens of pages of forms that require answers to a long series of questions about the project, even though most questions require an answer of only “no” or “not applicable.”

Review Process Once all application materials have been submitted to a research ethics committee, there are three possible next steps: 1. Exemption 2. Expedited review 3. Full review The ethics review board decides which action is appropriate.

Exemption Exemption from review may be granted—but does not have to be granted—when: the research involves the analysis of existing records or existing biological specimens that cannot be linked to individuals data will be collected as part of routine practice activities and are not intended to contribute to generalizable knowledge

Full Review Full review of the research proposal is usually required when: data will be collected through interaction with individuals an intervention will be tested in individuals or a community identifiable private information will be collected

Review by Multiple Committees Multiple research ethics committees may be required to review studies that involve researchers from multiple institutions and/or participants from multiple countries or multiple study sites.

Review by Multiple Committees At least three issues must be resolved prior to submission of a research proposal to multiple committees: 1. the application documents that will be required 2. the wording of the informed consent statement 3. the order of review

Ongoing Review All ongoing research protocols must be re- reviewed annually (or more often, at the discretion of the ethics review committee).

Conflicts of Interest When a financial or other interest could bias the design, conduct, or reporting of the study—or could merely appear to have the possibility of biasing the study—the potential conflict of interest must be disclosed. The disclosure of a potential conflict of interest is not a confession that bias has occurred or will occur. It is, however, an important assurance of transparency.

Is Ethics Review Required? Ethics review is required for almost every proposal that will involve human subjects. The decision to exempt a project from review can be made only by the relevant committees. Researchers are not allowed simply to declare that their projects do not need to be reviewed.

Incentives for Review Many incentives are in place to encourage participation in the formal review process: Institutional approval provides a degree of legal protection to the researcher Some granting agencies will not release funds until a research plan has been approved by an IRB/REC Many journals require authors to provide details about which IRB(s)/REC(s) reviewed the project

AND Code of Ethics

Dietetic Case Studies in Ethics