Has Your Research Study been Approved?: Five Approval Items to Consider Before Conducting Research
Has Your Research Study been Approved?: Five Approval Items to Consider Before Conducting Research
Whether conducting qualitative, quantitative, or mixed method research, researchers need to ensure all approvals are in place before beginning the study. Such study preplanning is important, as the lack of approvals can slow down or can stall a project before the research can begin. Responsible conduct of research requires the principal investigator (PI) to have approvals in place before beginning any study.
To assist principal investigators and their research teams in determining whether approvals have been given, the following five areas are discussed as guidance to help PI’s and researchers set up their study approvals. This article is written with a focus on University of Phoenix-affiliated researchers but much of the guidance and recommendations apply to other institutions.
Data Ownership Approvals
Data ownership does not rest with the PI or the research team once the study is completed. While data custody is with the PI or the research team during the research study, the University ultimately owns all data generated by research projects. The University of Phoenix holds unlimited access to its data, which is quite common, and this is one of the reasons for the PI to have Committee on Research approval if requesting to use University of Phoenix data sources.
Data ownership may reflect different interests for using the data. For instance, if working with a government agency, the agency would give the institution the right to use collected data to generate research designed for the public good. Private organizations, institutions, or corporations often hold the rights to the commercial or proprietary use of their data. Non-profit organizations and institutions often retain or grant ownership rights to the data depending on the organizations’ or institutions’ interests in the topic under study. An agency, organization, or institution can deny a PI’s or research team’s access to data for any reason.
Important Considerations for Data Ownership
There are some very important questions a PI or a research team should be considering in the design of the research study related to data ownership and approvals beyond the research design concerns:
- First, data ownership should be established; who owns the data to be used?
- Second, what are the specific rights does the PI or the research team have to publishing data or results? Ownership of the data does not always mean ownership of the product that emerges from the data; at the University of Phoenix, for instance, PIs and researchers own the articles they produce from the University data.
- Third, will data collection compel any specific responsibilities or requirements on the PI or the research team regarding the data management or data sharing? If so, what are those specific responsibilities or requirements?
For those who would like a clear explanation of data management and research ethics, visit the University of Alaska Fairbanks’ Office of Research Integrity data management site (link listed below in the References). In addition, the University of Alaska Fairbanks’ Office of Research Integrity site has an excellent discussion of export controls, which is important for international researchers to secure data.
Authorship and Role Approvals
Before engaging in a study, PIs and research teams need to discuss how various individuals qualify for authorship on an article, book, or other scholarly item that is produced. The order of authorship (first author, second author, third author, and so on) needs to be determined in advance and agreed upon by all members of the PIs or research team. A best practice outlined by The Johns Hopkins University is for authorship role approvals to “be clearly delineated at the initiation of the project” (Rules & Guidelines for Responsible Conduct of Research, The Johns Hopkins University School of Medicine, 2016).
Regardless of what is agreed upon by the research team, some types of authorship are not acceptable, such as ghostwriting or taking credit for the work of others or relying upon the material support of others without discussion. There also are three serious violations that all authors need to be aware of and guard against in their research and publications: fabrication, falsification, and plagiarism which do not include honest errors or differences of professional opinion when reviewing research or reporting research results. The violations are considered research misconduct, and increasingly more journals will hold all listed authors responsible. Therefore, authors need to pay close attention to whether the data are made-up, falsely presented, or published without appropriate citations.
Those who are interested in research misconduct cases and penalties can look at Price (2006) or Stretton (2011) and Stretton, Bramich, Keys, Monk, Ely, Haley, Woolley, and Woolley (2012) to see how the US Office of Research Integrity and major journals handle instances of research misconduct in authorship.
Institutional approvals from hospitals, clinics, schools, colleges, universities, and some businesses or organizations are often required before a study begins. The PI and research team should be familiar with the definition of ‘research’ under 45 CFR 46. 102 (d) to ensure any institutional approvals are in place. Under 45 CFR 46 (d) research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” In addition, if human subjects are involved, 45 CFR 46.102(f) states a “human subject means a living individual about whom an investigator (whether a professional or a student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (Office for Human Research Protections, 2008, hhs.gov). Identifiable private information is any information where the identity of the participant can be ascertained easily by the investigator or easily associated with the information.
PIs and research teams should note that it is up to the institution involved to determine whether institutional approvals are required and whether the institution is engaged in human subject research. The Office for Human Research Protection (OHRP) Human Subject Regulations Decision Trees are available in the University of Phoenix IRBNet Forms and Templates Library for review and can be accessed by PIs and research teams to assist with seeking institutional approvals.
Funder or Sponsor Approvals
PIs and research teams need to pay attention to the requirements of funders, whether federal funding, institutional/organizational support, or private grants/gifts. Be sure in advance that everyone involved on a research project understands what is required from the funder to gain approval. For example, the funder or sponsor may require human subject protections requirements, specific types of responsible conduct of research training, or a specific type of budgeting to receive funds. International funding streams may also have specific requirements or responsibilities, so PIs and research teams need to be aware that requirements may vary. A good article to learn more about international standards for research integrity is Resnik (2009).
For those who are considering military studies, it is very important to reach out to the specific Department of Defense branch (Air Force, Army, Navy/Marines, Coast Guard, and so forth) to determine if Department of Defense sponsor IRB approvals are required as well as UOPX IRB approvals. Similarly, those who wish to conduct studies at the Veterans Affairs (VA) offices will need to discuss whether VA approvals are required in advance.
The most common consideration for researcher approval is the Institutional Review Board. PIs and researchers at the University of Phoenix are required to have UOPX IRB approvals to receive University funding; however, PIs and researchers may also need location IRB approvals to conduct research on site. Please check with external site locations to determine if IRB approvals are needed. The University of Phoenix IRBNet Forms and Templates Library has a regularly updated list of Guidance documents for a variety of studies.
Responsible conduct of research and the expectations that journals have for PIs and research teams can be handled early and successfully with a little planning before setting up the research study. Knowing the types of approvals that are needed in advance can make the research study planning process much easier, especially when researchers are collaborating as a team. For more information about the types of approvals presented, see the references at the end of the article.
Johns Hopkins School of Medicine (2016). Rules and guidelines for responsible conduct of research.
Available at http://www.hopkinsmedicine.org/som/faculty/policies/facultypolicies/responsible_conduct.html
Office for Human Research Protections. (2008). Engagement of institutions in human subjects research.
Available at http://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on- engagement-of-institutions/
Price, A. (2006). Cases of plagiarism handled by the United States Office of Research Integrity 1992- 2005. Plagiary: Cross-Disciplinary Studies in Plagiarism, Fabrication, and Falsification, 46-56.
Resnik, D.B. (2009). International standards for research integrity: An idea whose time has come? Accountability in Research, 16(4), 218–228. http://doi.org/10.1080/08989620903065350
Stretton, S. (2011). Publication misconduct and retraction: Crime and punishment. Seventh annual meeting ISMPP.
Available at: www.ismpp.org
Stretton, S., Bramich, N.J., Keys, J.R., Monk, J.A., Ely, J.A., Haley, C., Woolley, M.J, & Woolley, K.L. (2012). Publication misconduct and plagiarism retractions: A systematic, retrospective study. Current Medical Research Opinion. Oct:28 (10): 1575-83. https://www.ncbi.nlm.nih.gov/pubmed/22978774 DOI: 10.1185/030007995.2012.728131.
University of Alaska Fairbanks. (2015). Data management. Office of Research Integrity.
Available at https://www.uaf.edu/ori/responsible-conduct/data-management/
University of Alaska Fairbanks. (2015). Export controls.
Available at https://www.uaf.edu/ori/export-controls/