Module 1: Intro to Research Flashcards
What is research?
It is collecting, analyzing, and interpreting information to extend knowledge
What are the 9 steps in Research Path/Scientific Method?
- Idea
- Literature Review
- Define the problem
- Develop the research question and objective. Develop hypothesis (in some cases).
- Develop research design, method, and a data analysis plan
- Implement study (collect & analyze data)
- Interpret results and draw conclusions
- Disseminate findings (through publications, presentation, press release, interviews)
- Develop the ‘next logical step.’
What is a primary research study?
“Original research”
A study conducted entirely by your team, OR data collected y others re-analyzed to answer a new question
What is a secondary research study?
The author of the source did not generate the research data they are using.
Example: Systematic or literature reviews
(TRUE/FALSE)
Research classifications equal data classifications.
FALSE.
What is primary data?
Your team collected it
What is secondary data?
Someone else collected it (made a data set), but you are re-analyzing it to answer a new question
What is the difference between ‘ethics’ and ‘ethical?’
ETHICAL: relating to moral principles or the branch of knowledge dealing with these
ETHICS: ‘Norms for conduct that describe ethical and unethical behavior.’
Why is Ethics important? (5 reasons)
- Promotes knowledge and avoids errors in the pursuit of knowledge
- Promotes collaborate work across disciplines and institutions
- Helps to keep researchers accountable to the public **
- Promotes values such as human rights and compliance with regulatory oversight
- **Public trust of research results is the only way that research can then be translated into useful and helpful clinical practice.
Who decides what is ethical? (2)
- Professional organizations, Academy of Nutrition & Dietetics, and CDR
- IRB of any university/facility where research is conducted (this is mandated by the FDA & Dept of Health & Human Services
What is the IRB?
Institutional Review Board
According to the FDA, it is an appropriately constituted group that has been formally designed to review and monitor biomedical research involving human subjects.
It is based on guidance from:
1. Nuremberg Code (1949)
2. Declaration of Helsinki (1964)
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974) - includes the Belmont Report (1979)
4. HHS and FDA (Code of Federal Regulations - Protection of Human Subjects)
Explain the purpose of the IRB.
To assure both in advance and by periodic reviews that appropriate steps are taken to protect the rights and welfare of humans who are participating in subjects in research.
To accomplish this purpose, IRB use a group process to review research protocols and related materials, such as the informed consent documents and investigator brochures to ensure protection of the rights and welfare of the human subjects.
What is the Nuremberg Code (1949)?
Developed in response to atrocities in research conducted by Nazis before and during WWII.
It includes 10 standards to which doctors must conform when carrying out experiments on human subjects.
It determined that subjects must:
1. Voluntarily consent to be in the study (meaning they understand the whole study process in normal terms).
2. Have the right to stop
3. Be protected from unnecessary physical and mental suffering and injury, disability, and death
4. The benefits of the study will justify the costs
(TRUE/FALSE)
Often, in IRB reviews, one of the things, that will be discussed is whether a particular procedure is absolutely necessary to answer the research question, OR if there is an alternative procedure that would accomplish the same research outcome while being a lesser burden to the participant.
TRUE
What is the Declaration of Helsinki (1964)?
World Medical Association 1964, 2013
Expansion of the principles outlined in the Nuremberg Code:
1. Medical research should protect the health, well-being, and rights of human subjects
2. MDs must be sure the risks are adequately anticipated and can be managed satisfactorily. The importance of the research must outweigh the risks.
3. Research with VULNERABLE GROUPS should only be conducted if it would benefit the needs of that group and only if the research cannot be conducted in a group that is not vulnerable.
4. At the end of the study, participants should be provided access to any beneficial outcomes that were proven effective (use a random crossover design to accomplish this).
5. **Specifically, adds a clause that mandates specific protections to “VULNERABLE GROUPS.”
Who would be considered a ‘vulnerable group’ in the Declaration of Helsinki?
- Any person who is physically, mentally, economically unable to protect themselves
- Pregnant women
- Children
- Prisoners
- Educationally disadvantaged
What is The Belmont Report (1979)?
3 Main Principles:
- Respect for Persons (Autonomy, Additional Protections)
- Beneficence
- Justice
Respect for Persons (Belmont Report)
Incorporates 2 ethical convictions:
- Individuals should be treated as autonomous agents
- Persons with diminished autonomy are entitled to protection
Autonomy
The right to self-determination and respects the individual’s right to make informed decisions
Beneficence
- Do not harm
- Maximize possible benefits and minimize possible harms
Justice
Equals ought to be treated equally; giving each person what he or she deserves
Providing fair and equitable treatment of individuals
What does the Code of Federal Regulations - Protection of Human Subject say?
It provides guidelines for:
- Ensuring compliance by research institutions
- Securing and documenting informed consent
- IRB operation
- Protecting vulnerable populations
What are 3 guidelines for ethical research with industry partners?
- Clarity and transparency in contract/grant expectations
- The researcher must maintain full autonomy over design and publications
- All financial relationships need to be openly disclosed in all reporting (publications, presentations, CV)
Personal observation - the more you are funded by industry, the more people may question your research ethics.
Define COI.
Conflict of Interest: a conflict between the private interests and the official or professional responsibilities of a person in a position of trust
(TRUE/FALSE)
A researcher must ensure a COI does not interfere with responsible, ethical research, or harm the participants or public, in any way.
TRUE
What are 4 types of COI?
- FINANCIAL: could be salary, consulting fees, stock options
- COMMITMENT: researchers must report time allocated to specific research projects
- PERSONAL: researcher review or grant application should always be done without bias with personal relationships
- INTELLECTUAL: researcher may have a bias against another researcher
**To fix any of these: have someone perform the research review
(TRUE/FALSE)
Financial interests of >$2,000 is considered “significant” by NIH.
FALSE
> $5,000
Plagiarism
The appropriation of another person’s ideas, processes, results, or words without giving appropriate credit
(TRUE/FALSE)
Plagiarism can be accidental.
TRUE
Copy/paste placeholder
What are 3 types of plagiarism?
- VERBATIM: act of representing someone’s words as your own, no matter the source
- IDEAS: presenting someone’s idea as your own
- SELF-PLAGIARISM/DUPLICATE PUBLICATION/RECYCLING
What are 4 ways to avoid plagiarism?
- Keep careful records of sources used
- Do not copy/paste, even as a placeholder
- Use a plagiarism checker
- Use a variety of sources
