STUDY PLANNING & DESIGN:
A SERIES OF ACTION STEPS
SECTION 03 – UNDERSTANDING THE ETHICS
Upon completion of this section, you will be able to write a carefully considered summary of the anticipated benefits and risks of your research, which can be used to demonstrate that your study meets the ethical standards of an IRB.
Action 1: Assess the Potential Benefits of Your Research
WHAT IS AN INSTITUTIONAL REVIEW BOARD?
An Institutional Review Board (IRB) is a committee that carefully reviews research proposals in order to protect human research subjects. The members of an IRB evaluate the risks and potential benefits of your research, the treatment of your subject population, the soundness of your methodology, and the value of the knowledge you expect to contribute. Now recognized as necessary to the ethical management of science, IRBs were created in response to 20th century studies that gravely harmed vulnerable participants, such as those carried out on concentration camp prisoners during World War II.
There are two documents that probably have had the most influence on the ethical worldview of IRBs: the Nuremberg Code (1947) and the Belmont Report (1978). The Nuremberg Code, a landmark paper that describes ethical standards for research, arose out of a tribunal that judged the immoral experiments orchestrated by Nazi scientists. The report stressed that researchers need to respect the autonomy of individuals and inform subjects about the nature of their studies. Relatedly, when you ask for a subject’s permission to be a study participant, along with informing him or her about the purpose and crucial details of your research, you are obtaining what is known as informed consent. A legacy of the Nuremberg Code is that IRBs must evaluate research proposals to make sure that informed consent is acquired properly from human subjects.
The Belmont Report built on the ethical guidelines laid out in the Nuremberg Code. Unlike its predecessor, the Belmont Report specifically emphasized the ethical treatment of vulnerable populations (those relatively or absolutely incapable of protecting their own interests)—a clear response to more recent examples of significant harm done to human subjects, like the infamous Tuskegee syphilis experiment (1932-1972) conducted by the U.S. Public Health Service. An enduring legacy of the Belmont Report is the idea that vulnerable populations require (such as children) special protections.
A BRIEF HISTORY OF IAED'S IRB
Editors of peer-reviewed journals take research ethics quite seriously, which explains why they require that your study receive IRB approval. But this requirement posed a problem for researchers who studied emergency dispatch, an emerging field where there were few experts to evaluate a proposal’s worthiness. For a long time, in fact, it was difficult for emergency dispatch researchers to receive IRB approval because existing committees did not have the capability to review dispatch-focused work. Facing this problem, Chris Olola established an IRB at the International Academies of Emergency Dispatch, a rare feat for a non-university. This IRB, chaired by Jerry Overton since its inception in 1998, is suited to review emergency dispatch research proposals.
Additionally, the report formulated important ethical principles that IRBs use to evaluate study proposals, one of which is the concept of beneficence. When you assess the possible benefits of your research against the potential harm to participants, you are evaluating the study’s beneficence, a word which roughly means the quality or practice of doing good.
WHAT IS A BENEFIT?
A benefit is a positive outcome of your research. Since an Institutional Review Board (IRB) determines whether your research is ethical based on an evaluation of your research’s benefits and risks, the committee wants you to describe your study’s positive outcomes. Based upon what you tell them, the committee must conclude that the good outweighs the bad for your proposal to be accepted. Of course, since you won’t know ahead of time what the outcomes of your research will be, you must describe the anticipated or potential benefits.
Describing the ethics of your study to an IRB can be compared to reporting tax information to the IRS. When filing a tax return, you don’t persuade the IRS how much in taxes you should pay. You fairly and accurately report your information to the IRS, and the rest is out of your hands. When writing your research proposal, similarly, the goal isn’t to persuade an IRB that your research is ethical. Instead, the purpose is to provide the committee and accurate and fair report of anticipated benefits and harms.
HOW DO I ASSESS THE POTENTIAL BENEFITS OF MY RESEARCH?
It might help to consider the expected applications of your results. For instance, a study that determines whether laypersons can effectively utilize tourniquets when following EMD instructions can be used to decide whether these instructions should be incorporated into a medical protocol. Likewise, for research that examines public attitudes towards 911, an application could be the development of training for emergency dispatchers on how to improve their services to the community.
CASE IN POINT - ASSESSING TURNOVER
An interview-based study on dispatcher turnover can have many applications. For instance, through gaining a better understanding why emergency dispatchers are leaving their jobs, a dispatch center can develop programs or materials to more effectively support its employees.
Action 2: Assess the Risks of Your Research
A risk refers to a possible harm done to a human subject. Even though you can’t predict with certainty whether any of your subjects will be harmed, you should be able to describe the specific harms that could reasonably occur as a result of your research. Once you understand the risks of your research, you are expected to take action to minimize the potential harms posed to your subjects. The list below describes six types of risks you should consider (adapted from https://rcs.uoregon.edu/content/examples-potential-risks-subjects):
|Physical Risks: examples include physical discomfort, pain, injury, illness or disease that are caused by research methods. Physical stimuli such as heat, cold, noise, etc. are associated with physical risks.|
|Psychological Risks: when research procedures can reasonably produce anxiety, depression, guilt, shock, or altered behavior, researchers are exposing subjects to psychological risks.|
|Social Risks: research can alter subjects’ relationships with others in ways that are harmful. Examples include research that causes embarrassment or loss of respect from others, or research that labels subjects negatively.|
|Economic Risks: through participating in a study, a subject can incur various financial costs such as loss of a job.|
|Loss of Confidentiality: if researchers use data that contains the private identifiable information of individuals, then their research can be harmful to those persons if that data is shared publicly. A research proposal therefore should reflect an awareness of this risk by outlining procedures that diminish the likelihood of a privacy breach.|
|Legal Risks: participation in research might require activities that could make subjects criminally or civilly liable.|
Most of the above risks arise from physical interaction with human subjects. However, keep in mind that your study might pose risks even if you are not physically interacting with individuals.
A retrospective study that relies upon ProQA records would be an example. In that case, loss of confidentiality (see above) is a potential harm. You could state that in response to this specific risk you will store the data in a secure location and limit access only to the study’s Principal Investigator (PI). Even though you haven’t eliminated all risk, at least you have shown that you take the welfare of your human subjects seriously.
CASE IN POINT - RISKS ASSOCIATED WITH INTERVIEWING DISPATCHERS
For an interview-based study that examines emergency dispatchers who have left their jobs, there are two main risks: interview subjects could be exposed to both psychological harms and loss of confidentiality. With respect to psychological harms, the interview might touch upon stressful or even traumatic experiences, for instance. Actions to minimize this risk might include avoiding asking questions about sensitive subject matter or approaching difficult personal topics with sensitivity and respect. And regarding loss of confidentiality, one should make sure that interview transcripts are kept confidential and never shared with third parties.
Action 3: Determine if Informed Consent is Needed
Earlier, it was mentioned that something called “informed consent” must be acquired from human subjects. But what is informed consent? Put simply, informed consent refers to a study participant’s voluntary consent given after receiving and understanding crucial facts and background about the research.
Federal regulations require that informed consent is documented through a signed consent form. But that does not mean informed consent is only a matter of getting someone to sign a document. Think of a consent document as a guide for a discussion about the implications of participation. At the end of the informed consent process, a subject should have an understanding of your research as well as the potential benefits and harms. You are only expected to gain informed consent from human subjects when you are conducting a study with human participants. If you are conducting a study that draws upon large amounts of EMS records, for instance, then it would be too difficult and time-consuming to track down every relevant individual and obtain their informed consent. In other words, informed consent is not required for retrospective studies.
CASE IN POINT - INFORMED CONSENT FOR INTERVIEWS
You should obtain informed consent from participants for an interview-based study on emergency dispatchers. Once you have a clear idea of the potential benefits and harms, as well as the purpose and background of your research, you can draft a consent document for interviewees to sign. To make sure that people understand the implications of involvement, you can discuss participation in the study with them verbally and assess whether potential subjects are indeed informed enough to participate.
Action 4: Write a Detailed Description of the Potential Benefits and Risks
If you’ve completed the previous actions of this section, then you should be able to provide an accurate description of your study’s anticipated benefits and harms.
Depending on your research design, your study might pose risks to human subjects beyond the potential harm individuals encounter during their ordinary lives. In this case, you should also explain how you plan to minimize these risks.
Finally, if you determine that you need to obtain informed consent, you should include a consent document as part of your IRB proposal (and you can obtain an IAED consent form template through contacting us). Information about the study’s anticipated benefits and harms form part of the crucial background that subjects need to be aware of before participation.
Find a partner or mentor. If you haven’t already, share with them your objectives and methodology. Have them check your description of anticipated benefits and risks to see if it is complete.