Understanding Investigator Conflict of Interest (ICOI)

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.

 

 

 

Who are Solutions IRB’s Clients?

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

Defining Research for IRB Review

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

Prisoner Research and Full Board Reviews

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 Risk in Criminal Justice Research

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

If it’s exempt why do I need an IRB review?

surveyThere is often confusion about “exempt review” among researchers, and this is entirely understandable. Sometimes we are asked: “well, I’ve already determined that this is an exempt study—so why do I need an IRB to do a review?” Projects that involve human subjects can be reviewed at one of three levels according to the federal regulations. The levels are exempt, expedited, and full committee.  The IRB does not actually approve an exempt study but makes a determination that the project meets at least one of the federal exempt categories criteria. 45 CFR 46.101(b) tells us that the categories for exempt human subjects research include:

 

CATEGORY 1

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

 

CATEGORY 2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

 

CATEGORY 3

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section. If (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 

CATEGORY 4

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

 

CATEGORY 5

Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

 

CATEGORY 6

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

 

Each one of the categories requires additional explanation.

 

CATEGORY 1 The research conducted in the educational setting must only involve accepted and normal educational practices—so this would not include a comparison of an accepted method to a new and untested educational practice. It also must take place in normal educational settings.

 

CATEGORY 2 The individuals participating in the surveys, interviews, educational tests, or observations cannot be children, nor can they be part of a vulnerable or protected population. Also, they cannot be asked questions that increase the level of risk for participation in the study. Note: The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.

 

CATEGORY 3 Under this category, the program The program must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). In addition, there can be no significant physical invasions or intrusions of the privacy of the participants.

 

CATEGORY 4 “Existing” means existing before the research is proposed to the institutional review board to determine whether the research is exempt. If the investigator will record the data so that no individuals can be identified, a step by step plan is required. Previously collected data can range from large data sets that are created by government-funded studies that occur at research institutions across the United States, to data that is recorded during the normal course of doing business in a setting such as a school, hospital or a corrections agency.

 

CATEGORY 5 This research involves organizations that provide a public benefit (such as broadcasting or public transportation) or service programs (such as Medicaid). No physical invasion or intrusion of privacy is allowable.

 

CATEGORY 6 This research involves consumer acceptance of products or services or taste and food quality studies—keeping in mind that these must normally be accepted foodstuffs!

 

As you can tell, after reading this blog, the determination of what is exempt and what requires a higher level of review is actually quite nuanced. This is the reason, an IRB is tasked with making the determination. If you have questions about a possibly exempt study—don’t hesitate to contact us and ask!

OHRP provides decisions charts for exempt and expedited reviews.

 

 

Deception in Research

Generally, Institutional Review Boards (IRBs) require investigators clearly and accurately inform human subjects about research during the recruitment and consent process. Human subjects are defined as a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information (§46.102(f) Definitions). Researchers must disclose the purpose of the study, benefits, potential risks and a description of what participants will be asked to do. Additional protection and safeguards may be needed for vulnerable populations. There are however, some instances in which deception or incomplete disclosure is allowed.

  • Deception occurs when the researcher provides false information to subjects about the research.
  • Incomplete disclosure is defined as the withholding of information about the purpose of the study.

The IRB considers several factors when reviewing studies using deception or incomplete disclosure. There must be a clear justification for the use of deception, why it is needed, and whether it is possible to conduct the research without it. Participants cannot be deceived about significant aspects of the research that would affect their willingness to participant or that would cause them physical or emotional harm. In most cases, a debriefing is required including a detailed description of the deception.  

There are instances in which the only way the research can be conducted is with deception or incomplete disclosure. Research examining the placebo effect may use deception. The American Psychological Association provides guidelines for the use of deception in research under Standard 8.07. The use of deception in research is allowable under certain conditions and carefully considered during the IRB review.

IRB Membership

The Common Rule (45 CFR part 46) published in 1991 is used by 15 Federal departments and agencies to provide protections for human subjects involved in research activities. The Common Rule also provides guidelines for the administration of the IRB and the composition of the board. Like many Federal regulations, some elements of 45 CFR part 46 are definitive while others are open to interpretation. This is true for the membership and qualifications of the board.

  • 46.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

(e) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB

 

The Common Rule does stipulate the board must have no fewer than 5 members and 1 must be a non-scientist. The Common Rule does not specify the education or training required for board members, only that they are “qualified” to conduct the reviews. Many IRBs require the same human subjects training for reviewers and researchers. Solutions IRB also requires initial and ongoing training of all reviewers.

The board of Solutions IRB consists of a diverse group of individuals. Many of the members of our board hold doctoral degrees and are experienced educators and researchers. Our membership includes the following:

Certified IRB Professional (CIP)

Registered Nurse

Registered Dietitian

Family Medicine Physician

Forensic Psychologist

Social Worker

Television Producer

Director of Research Information Systems

Licensed Behavior Therapist

Occupational Therapist

International Researcher

No convened board meeting can be held without the non-scientist. The non-scientist fulfills a very important role. These members often are drawn from the community in which an IRB resides. They may be members of local clergy, interested volunteers, teachers, retirees, nurses or ethicists. They also may represent ethnic, socio-economic or patient groups that add a needed voice to IRB decisions.

The guidelines provided by the Common Rule for IRB membership are followed by all IRBs. The specific membership of each will differ based on the types of studies reviewed, study populations, and settings. All IRBs strive to provide a thorough review to evaluate the risk/benefits and ethics of the proposed study for the protection of human subjects. For additional information on our IRB, please visit www.solutionsirb.com.

 

 

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