Evidence Based Practice Week 12 – Research Integrity

• The research process starts with creating a research question, determining outcome metrics, and figuring out the study design.

Institutional Review Board (IRB)

• Human subjects research requires evaluation and approval by an IRB.
• Studies must be IRB-approved to be conducted, published, or presented.
• Researchers submit an application with study details to the IRB.
• An informed consent form must be developed for participants to read, understand, and agree to.
• The IRB evaluates research study information and the informed consent procedure to determine if the study is ethical.
• The IRB consists of clinicians, research experts, ethics experts, statisticians, and legal representation.
• The IRB addresses ethical concerns such as unjustified patient risks and risk management.
• The IRB ensures risks are minimized, and confidentiality is maintained.

Human Subjects Research

• This research involves obtaining, using, analyzing, or studying data or biospecimens from living individuals through interaction or intervention.
• It also includes studies using private identifiable information from living individuals.
• Biological specimen studies, medicine administration, environmental changes, and administering surveys are examples of human subjects research.

IRB Exempt Studies

• These are studies that fall under the definition of human subjects research but don't require IRB approval.
• Education studies comparing standard educational techniques and using de-identified publicly accessible data are examples of exempt studies.
• Food tasting studies are also exempt.
• Case studies and case series do not require IRB approval.

IRB Decisions

• IRBs can approve, request more information, or reject study proposals.
• Researchers may need to make adjustments and clarifications to get approval, with the magnitude of revisions varying.
• Researchers can only start the study after formal IRB approval, usually in the form of a letter.
• Approval lasts for 1-3 years, after which re-approval is needed.

Informed Consent

• Participants must have the study explained to them and have the opportunity to read informed consent documents.
• Informed consent states that individuals can withdraw voluntarily at any time without any punishments.

Research Pre-Registration

• Pre-registration involves putting the study protocol on a public website.
• For clinical trials, it provides publicly accessible information to give patients the chance to participate and reduces selection bias.
• Offers research integrity by preventing retrospective changes to intentions or methods.
• Results can become available quicker than through the peer review process; however, they haven't been peer-reviewed.
• Prevents reporting bias.
• Federally funded research must post results within one year after the trial is completed.

Animal Model Research

• Contains ethical considerations due to potential pain and sacrifice of animals.
• Used when questions are hard to answer in humans due to length or invasiveness.

Animal Research – Caloric Restriction

• Caloric restriction studies for extending health span and lifespan are examples that are difficult to conduct on humans.
• These studies on animals have shown positive benefits

Animal Research Example – Life or Death

• Emergency room and life-or-death treatments are tested on animals.

Animal Research and Physical Therapy

• Examples include studies of chronic ankle instability and ligament healing.
• Rodents undergo ankle sprains or joint capsule cuts, followed by immobilization or wheel running.

Challenges in Translational Medicine

• Important to recognize that rodents and humans are not the same
• Key consideration is whether subjecting animal models to pain and disease is justified for the sake of improving human health.

Dissemination of Research

• Traditional forms include conference presentations and peer-reviewed journal articles.
• Many publications appear online ahead of print to reduce time lag.

Conference Presentations

• Conference presentations include poster and podium presentations.
• Poster presentations involve a large poster explaining the study, with the presenter answering questions.
• Podium presentations involve presenting the study on a screen to an audience, with questions at the end.
• Podium sessions offer full focus for 10-15 minutes, but can be missed if someone has a conflict.

Conference Abstracts

• Presenting research at a conference involves submitting an abstract, and some conferences ask for an entire paper.
• Abstracts have word or character limits and deadlines.
• Committee members review abstracts to determine acceptance.
• Conference acceptance rates vary.
• Conferences list all abstracts in a conference proceeding, now often online.

Peer-Reviewed Papers

• Peer-reviewed papers are generally viewed as more prestigious than conference abstracts.
• They undergo a more thorough quality control vetting process.
• The ultimate goal of a research study is to be published in a peer-reviewed journal.
• Research teams choose a journal based on its appropriateness, mission statement, and perceived prestige.

Understanding Impact Factor

• Impact factor is a quantitative measure of a journal’s prestige.
• It is calculated by dividing the number of times articles in the journal have been cited by the number of articles published in a given year.
• Researchers choose journals based on impact factor.

Journal Acceptance Rate

• There is a wide range in how likely a research is to be published or accepted for publication in a given journal
• Researchers have to consider submitting to journals with a high or low acceptance rate.
• Some articles may have been attempted to submit multiple times before finally being accepted.

The Peer Review Process

• Journals typically have a hierarchy of editors who make decisions on submitted articles.
• The handling editor receives the article and decides whether to send it for peer review or reject it.
• Rejections may not include feedback.
• If deemed worthy, the editor finds reviewers with appropriate expertise and invites them to review the paper.
• Researchers can recommend or not recommend reviewers.
• Reviewers critique the article, ensuring accuracy and appropriateness.
• The peer reviewer writes a summary with strengths, weaknesses, and recommendations.
• Recommendations can vary between journals.
• Recommendation types include accept, accept with minor revisions, revisions, not accepted or rejected but needs major revisions or reject and do not resubmit.

What Happens After Peer Review

• Research must perform a line by line response to the feedback that you receive if minor or major revisions in your research are required.
• The response should be direct to the reviewer which is then incorporated into the paper.
• Journals usually limit major revisions to two rounds before rejection.
• The editor has significant power in determining acceptance or rejection.

Peer-Review Process Summary

• Readers should assess the accuracy and usefulness of the research.
• The process involves humans, making it prone to errors, biases, opinions, and oversights.
• A peer-reviewed paper should be the beginning of a conversation and viewed with other papers on the topic.

Pre-Prints

• Pre-prints are copies of articles put on a special website called a preprint server made public before appearing in a peer review journal.
• Enables rapid release of information, but are not peer reviewed and readers must do their own quality control.

Predatory Journals

• Predatory journals sound like good peer-reviewed journals, but quality control is lacking.
• Have no quality control process.
• Journals will have similar names to prestigious medical journals
• Predatory publishers will solicit academics and scientists to publish in their journal.