Assignment Number 10

Human Subjects Review

Objective

Upon completion of this package, you will be able to:

Prepare the Human Subjects Review package for study approval.

Reading Assignment

Appendix B,  Application For Exempt Research                http://www.odu.edu/facultystaff/research/forms-policies-procedures

Appendix C, Human Subject Research Review Application Form http://www.odu.edu/facultystaff/research/forms-policies-procedures (mainly if studying people under age 18)

Complete a proposal package for submission to the University or College Human Subjects Review Committee.

OTHER READINGS:

Pyrczak and Bruce, pp. 109-116 (7th and 8th editions)

Research Evaluations

1. Is the problem clearly stated?
2. Is there a solution to the problem?
3. Is the problem researchable?

Rationale & Literature

1. Is the literature of previous studies of the same or related problems adequately reviewed or taken into account?
2. Are concepts essential to understanding the study defined?
3. Are objectives or hypothesis formulated?
4. Are the sampling methods adequately described?

Methodology

1. What type of research is being conducted?
2. What are the independent variables?
3. What are the dependent variables?
4. Is the population random and appropriate?
5. Was the instrument used justified?

Discussion and Conclusions

1. Do the conclusions follow logically from the presentation of results?
2. Does the discussion link the results with the previously cited research?
3. Are the conclusions reached by the author warranted by the rest of the investigation -- are they overextended?

CRITERIA FOR EVALUATION OF A RESEARCH REPORT, ARTICLE, OR THESIS

William B. Michael, University of Southern California, 1967

1. Title of article or report
   1. Precise identification of problem area, often including specifications of independent and dependent variables and identification of target population.
   2. Sufficient clarity and conciseness for indexing of title.
   3. Effective arrangement of words in title.

2. The problem
   1. Description and statement of problem.
      1. Statement of basic (felt) difficulty or problem situation -- significance and importance to the problem area in either basic or applied research.
      2. Careful analysis of know and suspected facts and explanations of existing information and knowledge that may have some bearing on problem -- the spelling out of specific factors giving rise to the basic difficulty, of their interrelationships, and of their relevance to the problem area.
      3. Soundness of the logic underlying selection of variables or factors to be studied and expression of their relationship to the problem area.
      4. Systematic and orderly presentation of the interrelationships of relevant facts and concepts underlying the problem.
      5. Clear identification of the problem statement through use of an appropriate heading or paragraph caption (the same requirement holding for other major categories of the research).
      6. Succinct, precise, and unambiguous statement of the research problem (including the delineation of independent, dependent, and classificatory variables), of the major questions to be resolved, or of the objectives to be investigated.
      7. Distinction (if required) between problems or questions that are either factually oriented or value oriented.
      8. Distinction in the instance of theoretically oriented research or of basic research between the purpose, which is often goal-oriented or instrumental in relation to certain pragmatic objectives, and the research problem which is primarily directed toward the finding of relationships, the making of comparisons, or the noting of changes (possible cause and effect relationships) relative to operationally formulated research hypotheses.

   2. Sufficient delimitation of the problem areas -- narrowing of the scope without becoming concerned with a trivial problem.
   3. Review and evaluation of the literature pertinent to problem areas.
      1. Adequacy and relevance of the previous investigation cited with reference to the basic difficulty posed, design of the current investigation, procedures followed, and projected analysis of data.
      2. Appropriate development of a rationale or theoretical framework from the research studies cited with reference to the current problem under investigation.

   4. Clear-cut statement of the conceptions, assumptions, or postulated underlying the problem being investigated.
   5. Precise statement of (1) hypotheses or (2) deduced consequences of theories or (3) the objectives of a study (objectives being most common in survey and descriptive research).
      1. Hypotheses involving relationships and comparisons.
      2. Presentation of deducible consequences or predictions (if any) that are logically consistent with an hypothesis (i.e., antecedent -- consequent statement: If A exists, then B follows).

   6. Definitions of terms
      1. Clarity in the definitions of key terms and variables (especially constructs).
      2. Use of operational definitions whenever possible.

3. Design and methodology (procedures)
   1. Logic, structure, and strategy of study carefully delineated.
      1. Distinction made between whether the research involves variables manipulated and controlled by the investigator (usually found in experimental research) or whether an ex post facto situation exists involving the analysis of data already available or collected as in most field studies and correlational investigations.
      2. Appropriate use of paradigms, flow charts, or schematic models.
      3. Specification of threats to external and internal validity of the design employed.

   2. Clear description of samples studied.
      1. Mode of selection of subject cited (e.g., random assignment, matching, voluntary participation, or convenience by being available).
      2. Data regarding how representative a sample is relative to a population.
      3. Information concerning the possible operation of selective drop-out and survival of the fittest.

   3. Adequate information pertaining to the reliability, validity, and standardization properties of instrumentation: psychometric characteristic of scales or tests used.
   4. Sufficient description of operation of field procedures followed in the collection of data-- where, when, and how data were obtained.
   5. Coordination of the specification of the relationship between the null (statistical) hypotheses and the research (problem) hypotheses.
   6. Appropriateness of the statistical treatment and data processing procedures.
   7. Evidence of a preparatory pilot study having been conducted.
   8. Procedure clearly enough described so that other investigators can replicate (repeat) the study performed under essentially comparable conditions in the future.
   9. Statement of methodological assumption such as adequacy of reliability and validity of measures, representativeness of samples, fulfillment of appropriate requirements for carrying out statistical tests.

4. Presentation and analysis of data
   1. Logical and orderly exposition in terms of the framework of the hypotheses, deductions, objectives, or questions asked in conjunction with the statement of the problem.
      1. Objective rather than subjective or speculative presentation.
      2. Analysis consistent with and supported by the facts obtained.
      3. Absence of over generalizations or sweeping statements that go beyond the data.
      4. Relationships of the findings to previously cited research explicitly shown.
      5. Negative findings relative to the hypotheses as well as positive findings presented with minimal distortion or bias.
      6. Uncontrolled factors influencing data outcomes appropriately cited and discussed.
      7. Weaknesses in the data honestly conceded and discussed with appropriate emphasis.
      8. Lack of confusion between facts and inferences clearly shown--separation of analysis of findings from interpretation and discussion of findings.
      9. Resolution of contradictions, inconsistencies, or misleading elements in the findings.

   2. Appropriate and clear use of charts, tables, figures, and graphs.

5. Summary and conclusion
   1. Precise and accurate statement of (1) the problem, (2) the methodology followed, and (3) the findings without the introduction of new or irrelevant information.
   2. Conclusions at a scope and level of generality justified by the data presented.
   3. Appropriate caution exercised and necessary qualifications made in drawing conclusions.
   4. Conclusions in a form that other investigators can understand and subsequently verify.
   5. Conclusions coordinated with the tentative acceptance or rejection of the research hypotheses presented or with the objectives or questions posed.
   6. New questions set forth for possible investigation--recommendations for additional research in the problem area study.
   7. Recommendations concerning implementation of the research findings when appropriate relative to the objectives stated in the purpose of the investigation (most frequently encountered in survey studies and action research).

KEY TO THE READING OF RESEARCH LITERATURE

ITEM	REALLY MEANS
1. It has been long known that original references, but...	I haven't bothered to look up
2. Of great theoretical and practical importance	Interesting to me.
3. While it has not been possible to provide definitive answers to these questions	the experiment didn't work but I figured I could at least get a publication out of it.
4. Three of the samples were chosen for detailed study	The results on the others didn't make any sense.
5. Typical results are shown	The best results are shown.
6. It is suggested. It is believed that. It may be that.	I think
7. Agreement with the predicted curve is: excitement good satisfactory fair	fair poor doubtful imaginary
8. It is generally believed that	A couple of other guys think so too.
9. It is clear that much additional work will be required before a complete understanding	I don't understand.
10. Unfortunately, a quantitative theory to account for the results has not been formulated	No one else understands either.
11. Correct within an order of magnitude	Wrong.
12. Thanks are due to Joe Clotz for assistance with the research and to John Doe for his valuable insight	Clotz did the work and Doe explained what it meant.
13. It is clear	It is not clear.
14. It is obvious	I think that is the way it should be, but I can't explain why.

Items 1-12 from The Physical Educator 19:3 (October, 1962), p. 103.

METHODS OF RESEARCH IN EDUCATION
by
John M. Ritz

LIBRARY USAGE

1. BOOKS - Card catalog, traditional method of identification. This method of identification is no longer used at Old Dominion University.
   • Online catalog - The electronic replacement system for the card catalog. All books are now found on this system.
   • Use reference book at each station or on-screen to get started. You can read or hit key F1 for Help! Usually reading the CRT screen will be all you need to get started.
   • After you have written the title, author, and number down for the books you seek, go to 3rd floor for A - PM and 4th floor for PN - Z. It is important to write bibliographic data to save you retracing steps if you cannot find the book.

2. PERIODICALS - Table inside the Reference Room has listings of all library periodicals.
   • Remember that some magazines have changed names so you should cross reference them.
   • The old methods of locating periodicals in the library was through the Education Index and Reader's Guide to Periodic Literature. Today these systems have been replaced with electronic systems.
   • Index in Education - right Table 15.
   • Refer to author or topic (e.g. Production in Vol. 29, page 792 - De-standardization: adding realism to the mass production activity, J. M. Ritz, Man/Society/Technology 38: 18-19 S/O '78. Or Ritz in Vol. 29, p.854). Supplements are not hard bound.
   • Reader's Guide to Periodical Literature - left side Tables 1 & 2.
   • Refer to particular topic. You have to look for each year in both the Index to Education and Reader's Guide.
   • The front of the guides list the periodicals included and the abbreviation used in the text.

3. Indexes - Are tools that cite research articles related to many topics. The reader uses the citation then looks up the reference to see if the citation is relevant to their study.
   • NEW YORK TIMES INDEX - Look either under topic or person being investigated. You will find date of publication. Papers found in micro-media room.
   • Current Index to Journals in Education - Right side, Table 14. This is part of the ERIC system. It contains educational journals just like the Education Index. Entries are found by subject and author. These can be cross referenced to find a description; by number in the first part of the index (e.g. Jan-June 1978; author, Ritz, p. 1467, EF 169 164 can be described on page 319). Also can look up subject.

4. Abstracts - These are synopses of major works. They summarize research and can at times be used alone in place of getting a copy of the complete study.
   • Psychology Abstracts - Left side, Table 5. Broken down by Table of Contents in front into major areas. Also contains subject and author indexes. Sections of abstract give description of entries. You find where journals articles are through the descriptive abstract section.
   • Dissertation Abstracts - Back rows on right, volume no. Z5055.U49.D57. These abstracts are divided into A for Humanities which education is a part of and B for Sciences. Each volume is divided into 2 months. Volumes contain listings according to subject and author. When you find the one you are looking for refer to the page suggested for an abstract of the dissertation (e.g. Wingerter, p. 6 of Nov. 88 Humanities Volume or p. 26 on topic, Curriculum; this tells me to turn to page 1054-A for the Abstract).

5. Reference Books - These are major volumes that contain selected works on major topics. All are research based and contain citations prepared by experts in the fields.
   • Encyclopedia of Educational Research - back rows, left side. Contains selected articles on research topics in education. The articles provide concise summaries of research and many references for further study. Look at Table of Contents for areas found in this volume. Ref LB 15.E48.
   • The Encyclopedia of Education - back rows, left side. Look in Index, Volume 10, to Guide to Articles to find particular topic then refer to Directory of Contributions in front section for author information. Also contains an index of articles in the back. This part gives specific Volumes (1-9) and pages where the articles can be found. Focuses on all aspects of education. REF LB 15. E47.
   • Cyclopedia of Education - back rows, left side. Broken down by volume in alphabetical order including topics and people. REF. LB15, M6.

6. Automated Reference Services - It is now possible to search various electronic databases in our library. Two new systems have been set up in the Reference Room of our library. These include ProQuest and Automated Reference Services.
   • ProQuest - computer systems on the right side of the Reference Room.
   • Periodical Abstracts - Provide indexing and abstracts to 1500 scholarly journals in all disciplines from 1986 to the present. See handout and reference guides for access. An appointment is needed to use these references.
   • ABI/Inform - This is part of ProQuest. It provides abstracts to articles published in over 800 business management, administration and marketing journals. This information is on the same computers as Periodical Abstracts.
   • Automated Reference Services - computer systems on the right side of the Reference Room. This is a CD-ROM database which has the capability to search various indexes and abstracts. An appointment is needed to use these systems. Some of the databases available on CD-ROM include: ERIC, PsycLIT, Electronic Encyclopedia, and Microsoft Stat Pack. Get an appointment and try out the ERIC database.