When is informed consent appropriate in educational research? Regulatory and ethical issues

IRB Ethics and Human Research

Volumn 24, Issue 1, 2002, Pages 1-8

  DuBois, James M ^a  

^a SAINT LOUIS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; EDUCATION; ETHICS; GOVERNMENT REGULATION; HUMAN; INFORMED CONSENT; LEGAL APPROACH; PROFESSIONAL STANDARD; RESEARCH ETHICS; STUDENT; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

EDUCATION; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; GOVERNMENT REGULATION; HUMANS; INFORMED CONSENT; STUDENTS; UNITED STATES;

EID: 0002271999     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564025     Document Type: Article

References (33)

1. Pedroni JA, Pimple KD. A brief introduction to informed consent in research with human subjects. Bloomington, Ind.: University of Indiana, 2001. Published at http://poynter.indiana.edu/sas/res/ic.pdf (last accessed 1-16-02). See also Patullo EL. Exemption from review, not informed consent [commentary]. IRB 1987; 9(5): 6-8; American Psychological Association, Draft ethical principles of psychologists, available at http://www.apa.org/ethics/code.html (last accessed 1-16-02). In contrast to the APA, the American Educational Research Association seems to require consent, and does not clearly distinguish assessment studies from research. See American Eduational Research Association, Ethical Standards of AERA, available at http://www.aera.net/about/policy/ethics.htm (last accessed 1-16-02.).
2. Pedroni JA, Pimple KD. A brief introduction to informed consent in research with human subjects. Bloomington, Ind.: University of Indiana, 2001. Published at http://poynter.indiana.edu/sas/res/ic.pdf (last accessed 1-16-02). See also Patullo EL. Exemption from review, not informed consent [commentary]. IRB 1987; 9(5): 6-8; American Psychological Association, Draft ethical principles of psychologists, available at http://www.apa.org/ethics/code.html (last accessed 1-16-02). In contrast to the APA, the American Educational Research Association seems to require consent, and does not clearly distinguish assessment studies from research. See American Eduational Research Association, Ethical Standards of AERA, available at http://www.aera.net/about/policy/ethics.htm (last accessed 1-16-02.).
3. Pedroni JA, Pimple KD. A brief introduction to informed consent in research with human subjects. Bloomington, Ind.: University of Indiana, 2001. Published at http://poynter.indiana.edu/sas/res/ic.pdf (last accessed 1-16-02). See also Patullo EL. Exemption from review, not informed consent [commentary]. IRB 1987; 9(5): 6-8; American Psychological Association, Draft ethical principles of psychologists, available at http://www.apa.org/ethics/code.html (last accessed 1-16-02). In contrast to the APA, the American Educational Research Association seems to require consent, and does not clearly distinguish assessment studies from research. See American Eduational Research Association, Ethical Standards of AERA, available at http://www.aera.net/about/policy/ethics.htm (last accessed 1-16-02.).
4. Pedroni JA, Pimple KD. A brief introduction to informed consent in research with human subjects. Bloomington, Ind.: University of Indiana, 2001. Published at http://poynter.indiana.edu/sas/res/ic.pdf (last accessed 1-16-02). See also Patullo EL. Exemption from review, not informed consent [commentary]. IRB 1987; 9(5): 6-8; American Psychological Association, Draft ethical principles of psychologists, available at http://www.apa.org/ethics/code.html (last accessed 1-16-02). In contrast to the APA, the American Educational Research Association seems to require consent, and does not clearly distinguish assessment studies from research. See American Eduational Research Association, Ethical Standards of AERA, available at http://www.aera.net/about/policy/ethics.htm (last accessed 1-16-02.).
5. Office for Protection of Research Risks. Exempt research and research that may undergo expedited review ["Dear Colleague" letter], 5 May 1995, 95-02. Available at http://ohrp.osophs.dhhs.gov/dearcoll.htm (last accessed 1-16-02).
6. See ref. 2, OPRR 1995.
7. Bellin E, Dubler NN. The quality improvement-research divide and the need for external oversight. American Journal of Public Health 2001; 91: 512-7. See also Pritchard IA. Searching for "research involving human subjects": What is examined? What is exempt? What is exasperating? IRB 2001; 23(3): 5-12; Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered research. JAMA 2000; 283: 2275-90.
8. Bellin E, Dubler NN. The quality improvement-research divide and the need for external oversight. American Journal of Public Health 2001; 91: 512-7. See also Pritchard IA. Searching for "research involving human subjects": What is examined? What is exempt? What is exasperating? IRB 2001; 23(3): 5-12; Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered research. JAMA 2000; 283: 2275-90.
9. Bellin E, Dubler NN. The quality improvement-research divide and the need for external oversight. American Journal of Public Health 2001; 91: 512-7. See also Pritchard IA. Searching for "research involving human subjects": What is examined? What is exempt? What is exasperating? IRB 2001; 23(3): 5-12; Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered research. JAMA 2000; 283: 2275-90.
10. See ref. 1, APA. The most recent (October 2001) draft of the APA Ethical Principles of Psychologists and Code of Conduct addresses assessment and educational research more explicitly than the 1992 Code. The draft code has not yet been formally adopted by the APA.
11. What may be the only article examining this subject in any detail from a legal and regulatory perspective is now outdated: Dellinger AM. Experimentation in the classroom: Use of public school students as research subjects. Journal of Law & Education 1983; 12: 346-78. A very recent, sensible discussion of when program evaluation in medical schools constitutes research is found in Henry RC, Wright DE. When do medical students become human subjects of research? The case of program evaluation. Academic Medicine 2001; 76:871-5.
12. What may be the only article examining this subject in any detail from a legal and regulatory perspective is now outdated: Dellinger AM. Experimentation in the classroom: Use of public school students as research subjects. Journal of Law & Education 1983; 12: 346-78. A very recent, sensible discussion of when program evaluation in medical schools constitutes research is found in Henry RC, Wright DE. When do medical students become human subjects of research? The case of program evaluation. Academic Medicine 2001; 76:871-5.
13. See, for example, Guidelines for the ethical treatment of students and student writing in composition studies. College Composition and Communication 2001; 52: 485-90.
14. See ref. 4, Pritchard 2001: 11.
15. Hammack FM. Ethical issues in teacher research. Teachers College Record 1997; 99: 247-65.
16. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: Government Printing Office, 1979: 3.
17. Office for Protection from Research Risks. Protecting Human Subjects: The Institutional Review Board Guidebook. Rockville, Md.: OPRR, 1993: ch. 2, question 11.
18. See ref. 9, Hammack 1997: 2. Later in his article (p. 15), Hammack seems to acknowledge this broader notion of normal educational practice.
19. While the Common Rule speaks of parental "permission" (at 46.402. and following) rather than consent, Department of Education regulations at both 34 CFR 99 and 34 CFR 98 (discussed below) speak of written parental consent.
20. Freedman B. Scientific value and validity as ethical requirements for research: A proposed explication. IRB 1987; 9(6): 7-10.
21. I thank an anonymous reviewer for this example.
22. See ref. 4, Bellin, Dubler 2001: 1514.
23. See ref. 1, AERA, at I.B.5.
24. Marcia Mentkowski has a helpful 12-point guide for providing students with a rationale for participating in assessment. See Mentkowski M. Institutional and program assessment at Alverno College [mimeograph]. Milwaukee, Wis.: Alverno College Office of Research and Evaluation, 1994.
25. See ref. 4, Pritchard 2001: 12.
26. Tobin K. Ethical concerns and research in science classrooms: Resolved and unresolved dilemmas. Science Education 1992; 76: 105-17. See also Robert Boruch's analysis of design of studies reported in the American Educational Research Journal at http://www.brookings.org or http://www.aera.net/gov/archive/r1299-03.htm (last accessed 1-16-02).
27. Tobin K. Ethical concerns and research in science classrooms: Resolved and unresolved dilemmas. Science Education 1992; 76: 105-17. See also Robert Boruch's analysis of design of studies reported in the American Educational Research Journal at http://www.brookings.org or http://www.aera.net/gov/archive/r1299-03.htm (last accessed 1-16-02).
28. See Gamble HF. Students, grades, and informed consent [case study]. IRB 1982; 4(5): 7-10.
29. See ref. 1, AERA, at II.B.5. Cp. ref. 1, APA.
30. The most recent draft of the APA ethical principles states: "Psychologists obtain informed consent for assessments ... except when ... (2) informed consent is implied because testing is conducted as a routine educational ... activity" (Ref. 1, APA, at 9.03). The idea of implied consent is also discussed in Lovat TJ. Bioteaching ethics and the researcher-teacher: Considerations for teacher education. Action in Teacher Education 1995; 16: 71-8.
31. See ref. 6, Henry, Wright 2001: 873.
32. American Psychological Association. Research ethics: Comments submitted by APA on the draft of the NBAC report on ethical and policy issues in research involving human participants, 16 February 2001. Published at http://www.apa.org/science/comment_nbac-oi.html (last accessed 1-16-02.).
33. See Howe KR, Dougherty KC. Ethics, institutional review boards, and the changing face of educational research. Educational Researcher 1993; 22: 16-21.