Human Subjects

Summary based on

Ravid, R. (1994). Practical Statistics for Educators

Gall, M., Borg, W. & Gall, J. (1996). Educational Research: An Introduction (6th Edition).

Popham, J. (1993). Educational Evaluation.

Research Ethics & Collecting Data from Human Subjects

Guidelines for legal and ethical standards in the design and conduct and reporting of research come from three places: government agencies have issued regulations, professional associations of researchers have developed statements, and universities and research institutes have established institutional review boards.

Governmental Regulation

Began after World War II in response to research conducted during the war. Nuremberg Code provided a statement of human rights to understand and freely choose whether to participate in research.

U.S. federal regulations began in 1960s and expanded in 1970s. Updated in 1991 (Federal Policy for the Protection of Human Subjects: Notices and Rules). Requires any institution that conducts research funded by U.S. government agencies to establish Institutional Review Boards (IRB). Government takes position that institutions should have review and protect rights of subjects regardless of funding sources.

Some research is exempt from review because of minimal risks - - including research involving the use of educational tests, survey procedures or observations of public behavior. Exemptions do not apply to research with children except when observing public behavior when the investigator is not participating in the activities being observed.

Professional Associations

AERA Ethical Standards - - most relevant to educational research. 45 standards organized under six topics.

American Psychological Association has Ethics Code which includes a general category of ethical standards and standards for evaluation, assessment of intervention’ advertising or public statements; therapy; privacy and confidentiality; teaching, training, supervision, research, and publishing; forensic activities; and resolution of ethical issues.

Institutional Review Boards

established locally and procedures and regulations may vary. Generally researcher must complete a form or protocol with attached instruments, letters of consent, and procedures for review by the IRB. General criteria include: clear research design, fair selection of subjects, subjects informed of how they were selected, voluntary nature specified, informed consent procedures, protection of privacy/confidentiality adequate, potential risks are identified and mitigated, benefits outweigh the risks.

Procedures to protect human subjects from risks

Selection - subjects must be selected equally

Informed Consent - individuals must be informed about the research and give their consent. (Minors give assent and parents/guardians must give consent for their participation). Schools/districts must also provide consent for research carried out in the schools. Subjects should be informed of: purpose of the research, description of procedures to be used (time required, etc.), a description of what will be done with the information, explanation of how they were selected, the voluntary nature of participation, confidentiality of data, potential risks, and their right to withdraw without penalty. Written letters must be in a language and at a level understandable to the subject and should contain information about who to contact with questions.

Right to Privacy

Subjects have a right to privacy and confidentiality. They should be told who has access to the data. Every effort should be made to prohibit unauthorized access to the data; a good rule - minimize the number of individuals who know the identity of the participants. In general, research data do not have privileged status. Confidentiality should be maintained in publications/ presentations (do not use the names of individuals, locations, etc.). There are some situations when the participants may want to be identified. Ways to enhance confidentiality: ask for anonymous information, use third parties to select sample and collect data, use a detachable identifier, have subjects make up a code when matched data is required, dispose of sensitive data after study is completed.

Right to Informed Consent and Protection from Harm

May consider risk-benefit ratio - - how much risk is the participant exposed to and how much good will likely result from the study. This comparison is subjective. Risks to subjects may be physical, emotional, psychological, or legal. In some cases, deception is needed in order to gather accurate information (deception creates a false impression in the minds of the participants by withholding information, telling lies or using accomplices). Some researchers are opposed to using deception in any research because they deem it morally wrong, it is not practical if one is interested in participant constructions, or because it has been too widely used among certain populations (college students). If deception is used, there must be two forms of debriefing - - dehoaxing (convincing subjects that they were deceived) and desensitization (removing undesirable effects - by suggesting that their behavior resulted from the circumstances of the experiment and not from a defect in their personality/character or that their behavior is not abnormal or unusual. (video aggression study example) Some argue that this promotes unethical behavior.

Ethical and Legal Issues

Planning and Designing Research

Researcher qualifications - - competence, perspective and character of researcher

Vulnerable populations - - dissimilarity with researcher may expose individuals to risk because of researcher’s lack of knowledge. Good approach to have members of the group help design the study.

Conflict of interest - - choice of data collection instrument or intervention has financial implications for the researcher.

Neglecting important topics - - -generalizing findings too far, ignoring ethnic differences, ignoring areas where research on the topic is relevant and needed

Conducting Research

Control group procedures - - subjects receive differential treatment

Termination of treatment condition - - research schedule may not coincide with participant needs

Use of tests - - test-anxiety, issues of self-disclosure, computer-based testing and issues of privacy.

Reporting Research

Partial and dual publication (salami science)

Plagiarism and paraphragiarism

Authorship

Human Relations

Locating a Research Site - - advantages and disadvantages of using your own institution (pro: easier to get approval, familiarity with context. con: limited view, bias, personal relationships)

Securing permission and cooperation - - clarity in describing research, concerns about costs and inconvenience, concerns about use of the information (negative reflection), issues of administrative hierarchy, informing of key groups/stakeholders (parents and community). Three areas of potential concern: conceptual soundness of the research (what’s the question, is it important, and is this likely to give us an answer), feasibility (how will data be collected, will it be disruptive, how much time is needed), and ethical concerns (does it place people at risk, what are the responsibilities of those participating, how will informed consent be obtained).

Building institutional relationships - - accessibility to site personnel, keeping them informed, developing warm and personal relationships, using expertise to address their needs.

Dealing with human relations problems - - build in additional time to deal with problems, public relations efforts.