Authors:  Ann Hardy, DrPH, CIP and Sherry Mills, MD, MPH, Learn eCORE

 

Investigators who conduct human subjects research generally want to advance scientific knowledge that will improve people’s lives. However, there may be situations in which an investigator’s professional judgment regarding his or her research could be negatively influenced by a secondary interest such as potential financial gain or professional advancement. These secondary interests are referred to as “investigator conflicts of interest” (ICOI). For example, an investigator may let the desire to complete a research project quickly to gain financial benefits or enable rapid publication to influence the conduct of his or her research. Allowing conflicts to dictate professional actions can have negative consequences for the outcomes of research and for research participants. Such actions can also erode public trust in the research enterprise.

 

Investigator conflicts of interest are generally categorized as:

1. Non-financial: Influences other than financial reward; for example, not recusing oneself from the review of a proposal from an organization where the investigator serves as an unpaid advisor.
2. Financial: A prospect of financial gain from the research; for example, owning stock in a company that could directly benefit from the outcome of a research project.

 

To prevent the negative consequences of conflicts of interest on research, there are federal requirements that must be followed to ensure scientific integrity and the welfare of research participants.

 

Requirements for Conflict of Interest in Research

 

In the United States, federal agencies that fund research have established conflict of interest standards that investigators must follow. For example:

• The National Institutes of Health (NIH) and the National Science Foundation (NSF) require that investigators follow very detailed regulatory requirements for identifying, disclosing, and managing financial conflict of interest (FCOI).
• The Department of Defense and the Department of Justice have more general requirements for funded investigators to disclose and manage both financial and non-financial conflicts.
• Investigators involved in Food and Drug Administration (FDA)-regulated clinical studies, regardless of funding source, must make financial disclosures at the time of application to the FDA.

 

The Declaration of Helsinki that applies to many international studies requires that investigator conflicts of interest be described in research protocols and disclosed in informed consent documents and in publications.

 

Private foundations, such as the American Cancer Society, also have policies for the identification, management, and disclosure of investigator conflicts for research they support.

 

It is critical that investigators be aware of and adhere to the requirements of their funding and sponsoring entities for both financial and non-financial conflicts of interest.

 

Identification and Disclosure of Investigator Conflict of Interest

 

For Non-Financial Conflict of Interest: Investigators should identify possible activities and relationships that could present a conflict of interest with their research. If required by a funding entity, investigators may also need to disclose these potential conflicts.

 

For Financial Conflict of Interest: Investigators must identify and disclose significant financial interests to a designated institutional official. This official will determine which financial interests could impact a particular research project.

 

Managing Conflicts of Interest

 

Once identified, conflicts of interest must be managed. Many investigators mistakenly believe that the only ways to manage conflicts are by severing relationships or by complete divestiture of financial interests. However, there are other strategies. For example, conflicts can be disclosed to potential research participants during informed consent or can be mitigated procedurally, such as blinding the investigators to the interventions in a clinical trial.

 

Failure to disclose, develop, or follow conflict of interest management plans may be considered non-compliance and may lead funding agencies to take actions such as delaying or suspending funding.

 

Conflict of Interest Training Requirements

 

Because the regulations and requirements regarding investigator conflicts of interest can be quite complex, many funding agencies and institutions require that investigators take periodic training on this topic.

 

Learn eCORE offers a comprehensive online training course on investigator conflicts of interest (ICOI) that covers both financial and non-financial conflicts and meets federal training requirements. Click here for more information.

 

About Learn e-CORE:

Learn eCORE offers online self-directed courses for anyone involved in human subject research. The courses provide timely and accurate certificate training on compliance and research ethics on two high-demand topics: human subjects protection and investigator conflict of interest.  Our courses are developed by leading subject matter experts and reflect high instructional design standards to enhance learning with interactive exercises, graphics, and realistic case studies.  Other unique features include optional continuing education credits for many disciplines, a companion Faculty Guide to aid teachers using our human subjects courses in the classroom, course availability in multiple languages, and complementary access to professional soft skills online courses and related tools for human subject researchers. Learn eCORE offers affordable and flexible subscription plans for individuals and groups.   Click here for more about Learn eCORE, the “The Expert, Affordable Alternative for Research Compliance and Ethics Training”.

 

About the Authors:

Sherry Mills, MD, MPH and Ann Hardy, DrPH, CIP, the co-founders of Learn eCORE, have decades of experience conducting public health research, developing federal research policy, and creating comprehensive training programs such as the former National Institutes of Health (NIH) online course “Protecting Human Research Participants” that trained millions world-wide from 2009-2018.  Additionally, they have over 10 years of service as Institutional Review Board (IRB) members and have consulted with major federal agencies such as the Office on Human Research Protections (OHRP). Drs. Mills and Hardy also are active in teaching others about grant writing and research program development.

 

 

 

Solutions IRB works with a number of clients involved in social-behavioral and clinical/biomedical research. We assist a wide variety of researchers such as those who are independent, sponsors, and clinical investigators. Our highly qualified administrative and reviewer team assists researchers in the protocol application process and works with them to ensure their study design is at an ethically sound level that will serve as the basis for credible research.
The study teams Solutions works with range from novice level to highly experienced researchers. Regardless of the research exposure level, we provide the assistance necessary to navigate the application and review process. The Solutions IRB Reviewers have a wide variety of experience to cover all areas of research, including clinical/biomedical, social/behavioral, educational, vulnerable populations (e.g., prisoners, youth, etc.), military, international research, and more.
Solutions IRB has been a private institutional review board for over 10 years and is accredited by AAHRPP. Regardless of their experience level, we look forward to working with researchers as they navigate through the application and review process!

Author: McKenzie Long

While clinical studies typically require IRB review, it might not be as clear for a social- behavioral study. The following checklist of questions can assist a researcher in deciding whether or not an IRB review might be appropriate.

Is the ultimate goal to publish the study findings? If the answer to this question is ‘Yes’, the researcher should consider obtaining IRB approval prior to beginning the study. Most peer-reviewed journals require that the study complies with ethical research guidelines. Obtaining IRB approval ensures this requirement is met.

Does the funding source require IRB approval? Many grants and sponsor-based sources will require as a condition of funding that the study be approved by an IRB. Researchers should check the funding agreement to determine whether or not this is a requirement.

Does the research involve human subjects? If direct interaction will occur between the researchers and human subjects, it should be assumed IRB review and approval will be required. Federal guidelines dictate specific protocols that must be followed when research involves human subjects. An IRB is the body designated by Federal guidelines to review study protocols to ensure the ethical rights of human subjects are protected.

Does the study involve a program evaluation? The answer to this question is dependent upon various factors. If the program evaluation is being conducted solely for internal quality assurance, an IRB review is not required. However, if the program evaluation is a requirement of the funding source or needed to substantiate to external sources the on-going existence of the program, an IRB review is required.

Does research involving secondary data analysis require IRB approval? Again, the answer is dependent upon various factors. In situations where the secondary data has been completely de-identified prior to receipt by the researchers, IRB approval may not be required. However, the researcher(s) might want to obtain an Exempt or Expedited category approval if the findings will be published. If the researcher(s) will be deidentifying the data after it is received from the original source, the study should be reviewed by an IRB.

Author: Dr. Ron Wallace, PhD

The IRB has been asked in the past whether all studies involving prisoners and/or prisoner research require a full board review. As defined in CFR 46 Subpart C, prisoners are considered a vulnerable population. Given the fact that prisoners are considered a vulnerable population, any study that directly involves their participation must automatically be classified as a full board review.
It is important to keep in mind that the risk for coercion and undue influence to participate is extremely with high when prisoners are the participants in a research study. The combination of their classification as a vulnerable population, along with the risk for coercion and undue influence to participate, dictate the need for the level of review provided by full board status to ensure their rights as human subjects in research are protected.
There are however some instances where prisoner research would not require a full board review. For example, if a study is looking only at archival data about prisoners, the study might qualify for an Expedited status. Even in these types of studies, precautions are required to ensure adequate protections for the prisoners.
Types of precautions that would be required is ensuring that all identifying information (e.g., prisoner ID number and name) has been removed from the dataset. Another precaution is ensuring that no interaction occurs between the prisoners and the research team.
Best practices for this type of prisoner research would include obtaining aggregate datasets which decrease the chances of any specific data elements being tied to one specific inmate. Also, the removal of any identifying information prior to passing it to the research team increases the confidentiality of the prisoners. The research team could commit to removing these identifying elements after receipt of the data, however in those situations the IRB needs to ensure appropriate security measures are in place to prevent the accidental release of the original dataset that included identifying information.
Finally, a researcher might explore whether a secondary dataset already exists in the public domain that would satisfy the study requirements. An existing secondary dataset would already have all of the identifying prisoner information removed.

Author: Dr. Ron Wallace, PhD

Coercion and undue influence are risks that must be considered when recruiting study participants that are involved with the criminal justice system. Prisoners are considered a vulnerable population per CFR 46 Subpart C. Prisoners that are subjects in research are at risk of coercion and undue influence to participate.
While not designated as vulnerable populations by the Common Rule, concerns related to coercion and undue influence to participate must be considered for other individuals in the criminal justice system. This includes not only individuals under some type of supervised status (e.g., pre-trial, probation, parole, community corrections, halfway house, etc.), but also victims.
Similar to prisoners, individuals in a supervised status within criminal justice are at high risk for coercion and undue influence to participate. These individuals report to a supervising individual that has the authority to recommend incarceration in the event conditions of release are not met. If the opportunity to “volunteer” for research is presented by the supervising authority, it could be interpreted by the individual as an expectation, no matter how clearly the “volunteer” aspect is stressed. For this reason, a good rule of thumb is to have a 3rd party with no role in the supervision conduct all recruitment activities.
Crime victims are not under any type of supervision; however they may feel some type of obligation to those that assisted them. A bond can form between victims and victim advocates as they work their way through criminal proceedings. As a result it is advisable to find a 3rd party that was not involved with the criminal proceedings to conduct all recruitment activities involving victims as study participants.
A final group that is often overlooked in this category are family members of offenders. While these individuals are not directly at threat of repercussions, they can often sense that their family member involved with the criminal justice system might be negatively impacted if they fail to participate in research. For example, the family of a prisoner might think the parole opportunity for the offender could be negatively impacted if they refuse to participate in the research. Again, having some type of 3rd party conduct all recruitment activities is the best approach to negate this issue.

 

Author: Dr. Ron Wallace, PhD