Getting a new research compliance software system can definitely pose challenges. But many tend to overlook the problems that can arise post-implementation, especially in the training phase. Despite the fact these systems are an essential part of a needed digital transformation for IRB, researchers, and IACUC committees, the training can be a sticking point for users. Many become frustrated early in the training... Read More
New researchers frequently ask, “What does the Institutional Review Board process look like?” While every research proposal is different, the review process generally includes:
- An initial administrative screening where the IRB administrator checks that all parts of the proposal are uploaded and complete (e.g., consent form, recruitment script, etc.).
- A revision step where the Primary Investigator (PI) is contacted and asked to upload any missing parts or address any suggested edits.
- A formal review process where reviewers examine... Read More
The effort to modernize old processes tends to be met with a lot of reticence in most organizations, regardless of size. Traditionally, organizations have remained steadfast in their decades-old systems. It might prove difficult to convince others to give up their paper-based processes in favor of a new online research compliance system. Researchers, IRB, and IACUC committees and their staff are mired in paper-based clerical functions, and an online compliance system can be an incredibly powerful tool... Read More
Adopting research compliance software, especially an online IRB system, as a small or mid-sized organization might seem like an overwhelming challenge. When considering the number of resources it takes to implement, train and onboard, as well as time, it might not seem like a worthy investment. However, Axiom’s Mentor system provides a host of benefits that can greatly contribute to increasing speed, efficiency, and overall convenience for your compliance office. Mentor IRB can become the... Read More
In many disciplines, funding agencies are expecting researchers to share their research data as a part of their research practice. While data sharing has benefits and can mobilize continued research, researchers are legally and ethically obligated to prevent accidental disclosure of sensitive information. Researchers’ attitudes towards sharing data may vary. It is important to understand the process of data sharing and develop a thoughtful plan describing how and why to share data. The following... Read More
It’s a new year and a fresh start to research in 2018. New researchers are beginning their IRB protocols and it is important for them to know the difference between four key terms associated with data collection: Anonymous,Confidential, De-identified, and Identifiable. Below are some examples of these key terms. Data in the following examples is used generally and can include numeric data (e.g., surveys) and qualitative materials (e.g., interview transcripts and field notes).
- Anonymous – Anonymous data is collected in... Read More
A new researcher visited my office in a panicked state and expressed his concern about his upcoming study. He was already trained to conduct human subject research and IRB approved to conduct his study, but in his words, he did not “feel ready” to collect the data. His experiences reminded me of the first time I collected data as a master’s student. I collected and analyzed hundreds of personally archived historic letters exchanged between community leaders... Read More
Axiom Research Compliance invites you to joiin us for a webinar, The Use and abuse of IRBs. This webinar focuses on IRB practices in reviewing social science types of research projects. IRBs are prone to mission creep and mis-interpretation of the federal regulations. This webinar will guide participants through the application of the regulatory definitions of research and human subjects and minimal risk, the exemption categories, as well as discuss issues of scientific design in... Read More
Researchers need to meet deadlines, but it is sometimes difficult to figure out everything that has to be done. As such, we created a general student timeline that follows a linear path from initial research conceptualization to graduation. This general timeline highlights nine typical markers for successful student research, but some students may conduct pilot studies or other forms of research that do not strictly follow this general timeline.
- COMPLETE HUMAN SUBJECT TRAINING: All team... Read More
Subject recruitment for research cannot begin until written approval from the IRB is obtained. However, researchers can describe how and when they intend to select and recruit their subjects in their IRB protocol. IRB reviewers will often ask that researchers answer the following questions regarding subject selection and recruitment:
- How will the researcher access the participant group?
- Has the researcher clearly explained the process for recruiting participants?
- Did the researcher create materials to contact people and... Read More