Assignment: Local Health Fair NUR 550

Assignment: Local Health Fair NUR 550

Assignment: Local Health Fair NUR 550

DQ1 You attend a local health fair organized by several health care research companies. You notice that a company is distributing a trial drug to other attendees at one of the booths. When you approach one of the researchers, you are offered a waiver to sign for participation in the trial.

What ethical or legal parameters should the researchers have considered prior to distributing the trial drug at the health fair? If you were on the translational research team, what steps would you have taken to maintain ethical and legal guidelines?

How do you host a health fair?

Wellness & Health
Fair Planning Guide
Remember that different people respond
to different messages, so use as many
methods as possible to promote an event.
Think about how messages and memos are
normally communicated in your organization.
If a certain method of communication that
works well in your workplace, start there.
Promote the event at least four weeks in advance.
Consider using a different method or a variety of
methods to communicate the event each week.
Keep the messages simple and interesting by
adding more information with each message
(teasers). This can raise curiosity and anticipation.
Don’t forget that word of mouth is often the best
method of communication. Therefore, you will
want each person on your planning team to talk
up the event (in hallways, in elevators and at
meetings). This also works well on the day of
the event. Before participants go back to their
workstations, remind them to tell others about
the event and encourage them to attend.
Here are some ideas to promote your
health fair. Remember to pick a variety of
methods to help ensure a large turnout:
• Voicemail message reminders
• Table tents in break rooms and cafeteria
• E-mail messages
• An article in the company newsletter
• Banners
• Announcements at employee meetings
• Paycheck stuffers
• Word of mouth
• Flyers on everyone’s desk the
morning of the event
• Intranet postings
• Flyers that offer an incentive to
participate in the event
• Place posters in highly visible
locations such as:
− On the door of the employee entrance
− In the copy room
− On restroom mirrors and the
back of stall doors.
− Under the windshield wiper of each
employee car in the parking lot
− In the elevators and/or staircases

Health fair drug distribution , in my opinion , creates an unsafe and unethical environment Health fairs do not offer time or adequate patient privacy for research. Who will foster this recruitment ? How does one apply and management concepts and effective training methods to manage risk and improve quality in the conduct of a clinical research study while random participants at a health fair are your participants ? Subject recruitment and retention is an essential step to help lowering the cost and the length of clinical trials ( DeRenzo, 2006).Good Clinical Practice (GCP) is international guideline to ensure that clinical trials are designed, conducted, implemented, monitored, audited, recorded, analyzed, and reported scientifically and ethically. It also aims to protect human subject rights, integrity, and confidentiality. In 1997 GCP became effective, though not legally acknowledged at that point. In 2004, in the United Kingdom/Europe GCP became a legal obligation for all clinical trials involving investigational products. (Vijayananthan, 2008). According to the ICH-GCP guidelines all clinical trials should be conducted in compliance with ethical standards, clear scientific proof, and benefit over weigh risk; and a clear well-documented protocol is required. Obtaining an informed consent and affirming confidentiality. The trial staff should receive adequate training along with their appropriate qualifications. Data should be documented accurately and easily accessible and available. Manufacturing the investigative products should be in accordance with Good Manufacturing Practice (GMP) guidelines.Individuals should be treated with respect from the time they are approached for possible participation if they refuse enrollment in a study—throughout their participation and after their participation ends. This includes: Respecting their privacy and keeping their private information confidential. Respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without penalty. Informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating. Monitoring their welfare and, if they experience adverse reactions, untoward events, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study. Informing them about what was learned from the research. Most researchers do a good job of monitoring the volunteers’ welfare and making sure they are okay. They are not always so good about distributing the study results. If they don’t tell you, ask
References:
DeRenzo EG, Moss J (2006) Writing clinical research protocols: Ethical considerations. Burlington, MA: Elsevier Academic Press.
Vijayananthan A, Nawawi O (2008) The importance of good clinical practice guidelines and its role in clinical trials. Biomedical Imaging Intervention Journal 4: e5. [Crossref]

Discussion A : Angela, Great post as well as a through point of view from an advanced practice nurse view point. standardizations on all accounts from patients history, to drug knowledge, to adequately trained medical professionals along with the legal FDA standards of research guidelines are among a few things to consider. Implementation of the Harmonized Core Competency framework the Core Competency Framework can be used in many ways to improve the quality and safety of the clinical research enterprise; for example, to define criteria used by professional certification and site accreditation agencies. The Core Competency Framework can be used to formulate accreditation standards for academic programs to both standardize curricula and to ensure that programs are sufficiently comprehensive.The greater challenge is to implement this conceptual framework in clinical research design and conduct. A comparison of two different types of studies reveals differences in competency requirements. For instance, when an investigator-initiated observational trial is compared to an industry-sponsored pre-market interventional clinical trial, it is possible to see how the Framework might be used to qualify a principal investigator. As illustrated in Table 3, the competencies for the Study and Site Management Domain are identical, but not so for the Scientific and Research Design Domain

Competency Framework Working Group. Competency Framework for clinical research nurses: A tool to promote patient safety and quality data. 2nd ed: Competency Framework Working Group; 2011: http://www.rcn.org.uk/_data/assets/pdf_file/0019/201466/Research_Nurse_Comptency _Framework-Version 2-Full-Oct_2011.pdf