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