1. Ethics and Research: Presentation 6By
Michael G. Parker, PT, PhD, FACSM
Professor

2. Summary of AMA & Department of Physical Therapy Format and Citation Style can be located on pages 40 – 42 in the Department of Physical Therapy Research Handbook.
Proper Citation of Authors Ideas Ensuring Credit for Intellectual Property-Citation Styles

3. In-Text References- What are They? When are They Used?
A reference or citation gives credit to the creator of an idea or work.
In text references(citations) are used in the narrative of your paper to cite the ideas or work of the authors /researchers.

4. Research: Style Guides
Writing Style - Rules that apply to spacing, headings, rhetoric and grammar, and the presentation of tables and figures
Citation Styles - Rules that apply to giving appropriate credit to the work of other researchers and/or authors in the text and reference list
American Medical Association (AMA) writing style & citation style is used – see PT Dept Research Handbook, AMA Style Guide, Read AMA PowerPoint Research Module.

5. Smith1 compared strength …
Document Your study in Text by Citing the Work You Researched Using Arabic Superscript Numerals Consecutively
One Work by One Author:
Smith1 compared strength …
The 2 largest studies on strength included 100 patients1 and 80 patients.2
*Citations are numbered with superscript arabic numerals in the order they are cited in the text.
*Superscript numerals outside periods & commas.

6. In Text Citations of Works by Multiple Authors
When a work has two authors always cite both names every time the reference occurs in text:
Smith and Johnson3 observed …
When a work has more than 2 authors use
“et al”
For Smith, Johnson, and Sting use:
Smith et al4

7. The Reference List: See Section 2. 12. 2, p
The Reference List: See Section , p.29 AMA Manual of Style, 9th edition
Citations briefly identify the source for the readers, and allows them to locate the source of information in numerical order (not alphabetical) of presentation in the text at the end of the manuscript.
Cite articles that only are used in the research and preparation of the manuscript

8. Consistency of Text and Reference List
Text citations must appear in the reference list
Each article in the reference list must be cited in the text

9. References Page – AMA Style Checklist
Center the title “References” at the top of the page (1-1/2” margin on the left, other margins are 1” ,top, bottom, & right margins)
All sources mentioned in the text must appear in the References list, except personal communications or interviews
Every source listed in the References list must be mentioned in the text

10. References Page – AMA Style Checklist continued ...
The Reference list IS ONLY DOUBLE SPACED.
Style for Reference List can be found for most kinds of citations in Section 2.12 pages 28 to 51, in the AMA Manual of Style 9th edition. Please refer to this for punctuation and required citation content.

11. Institutional review Board (IRB) ethical review of research for the protection of human research participants (subjects)

12. Protecting Individual Person’s Rights
Patient’s Rights
Research Participants (Subjects)
Principle of Utilitarianism- penalize a few for the good of others; greatest good for the greatest number

13. Ethical Role1 of The Physical Therapist in Research is Guided by:
High Standards for quality Research
Standards to Protect Research Participants
Standards for Publishing Results
Report Unethical Acts in Research
Support Research that produces new knowledge
1 APTA Code of Ethics & Guide for Professional Conduct

14. The Nuremberg Code (1947): 1st set of Ethical Principles for Medical Researchers:
Voluntary Consent of Human Subjects is Absolutely Essential
Animal Experimentation should Precede Human Experimentation
Physical & Mental Suffering, & Injury Should be Avoided
Human Risk Never Should Exceed The Benefit to Society, & is Minimized

15. The Declaration of Helsinki
Developed by the World Medical Association
Provides an Ethical Guide for Clinical Research
Informed Consent a Central Requirement

16. The Declaration of Helsinki
Surrogate Consent Allowed if research participant physically or mentally incapable of Giving Consent, or is a minor.
Research Requiring Surrogate Consent should only be done, if the research promotes the health of the population represented by the incompetent research participants

17. The Declaration of Helsinki
Forbids the use of a placebo group if an accepted treatment already exists
“In any medical study, every patient-including those of a control group, if any, should be assured of the best proven diagnostic and therapeutic method.” 2
2 World Medical Association. Declaration of Helsinki. 1997;277:925-6.

18. Dealing with Unethical Placebo Comparisons3
Equipoise is essential for an ethical human experiment
“Equipoise… a state of genuine uncertainty about which of two or more treatments is preferable”.3
Ethically, when testing a new treatment, all research participants should receive a standard accepted treatment.

19. Unethical When Equipoise is Not Applied by the Researcher
When Equipoise is not satisfied, the researcher believes 1 treatment is better or worse than another; thus, deliberately assign some patients to a treatment group they believe to be inferior. ,i .e. a placebo group

20. Belmont Report 1979: Ethical Principles Underlying Research
Respect for Persons: Individuals should be treated as autonomous agents
Beneficence: Researcher maximizes possible benefits and minimizes possible harm
Justice: A balance of who bears the risks of the research and who receives the benefits.

21. Informed Consent Supported by the Principle of Autonomy
Possible Research Participants must be availed the information they require to determine whether or not they desire to participate in the study.
No pressure to participate and enough time given to decide

22. What is Informed Consent in Research?
Research participants enter into the research study voluntarily and with adequate information.
Respect for persons demands appropriate informed consent.

23. Information Included in An Informed Consent Document
Statement that the study is research
Purpose of the research
Description of research procedures
Description of foreseeable risks or discomforts, an estimate of their likelihood
Description of benefit, an estimate of their likelihood

24. Information Included in An Informed Consent Document
Disclosure of alternate treatments that may benefit the participant
Description of how records will be kept confidential and who may have access to the records
Description of compensation and medical treatments, if injured while participating
Description of whom to contact with questions

25. Information Included in An Informed Consent Document
Statement that participation is voluntary and that refusal to participate or a decision to withdraw can occur without prejudice or penalty to the participant
Statement indicating that the participant is making the decision to participate, and that he/she has read and discussed information presented.

26. Special Information That May Be Required in the Informed Consent
If the participant is or may become pregnant during the study; treatment could be a risk to the unborn
Description of circumstances in which participation could be terminated by the researcher, without participant’s consent.
Statement that researchers will notify participants of any new findings developed during the study that may influence the participants desire to continue in the study.

27. Institutional Review Boards (IRBs): What is their Duty?
To protect the rights, safety, and welfare of human research participants

28. Institutional Review Boards: How do they protect human subjects?
Review the full protocols of planned research to ensure ethical principles are maintained
Confirm research does not expose subjects to unreasonable risks
Conduct continue review of on-going research (1/year)
Consider adverse events caused by research
Assess suspected protocol violations and/or complaints from research participants

29. Institutional Review Boards: Who is on the Board?
Qualified individuals who have no vested interest in the research or its outcomes
Federal regulations requires at least 5 members
Diverse professional members, gender
Scientific, non-scientific, clergy, & at least 1 member not affiliated with the institution

30. Types of IRB Reviews: Expedited Review
For research involving no more than minimal risk, or for minor changes in approved research.
A single voting member (usually the Chair) performs the review.

31. Types of IRB Reviews: Full Board Review
A quorum of IRB members are present at the meeting
The research proposal is presented and discussed
For approval, a majority of the voting members present, vote approval. An abstention counts as a negative vote