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

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

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.

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.

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.

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

The Reference List: See Section 2. 12. 2, p The Reference List: See Section 2.12.2, 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

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

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

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.

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

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

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

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

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

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

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.

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.

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

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.

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

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.

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

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

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.

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.

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

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

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

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.

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