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Team b week 4 hcs465 march 21, 2016 ethical scenario 1
1. ETHICAL SCENARIO DNA
RESEARCH
Braquel Cone, Megan Cross, Roxanne Crowder, Genevieve
Greene, Sherry Hugger, Ana Jacobs
HCS/465
March 21, 2016
Dr. Chad Moretz
2. OBJECTIVES
HIPAA Patient Privacy and Consent
Risks and Benefits of DNA Research
Consent
Collection Procedures
Challenges
Financial Conflicts
Ethical Implications / DNA Research
Avoiding Bias In Research: Ethical Principles
3. HIPAA PATIENT PRIVACY AND
CONSENT
• Privacy of Individual Identifiable
Health Information ( Privacy Rule)
• Protection of Human Subjects
(Common Rule)
• Consent
Photo Courtesy of: http://www.conceive.ca/patient-resources/treatment-consent-forms/
4. RISKS AND BENEFITS OF DNA
RESEARCH
• Consent for collection and storage
• Future data
• Identify disease-associated gene
• Physical risk are less likely
• Future research is undefined
• Misuse of information
• Identifiability intensified
• Better communication on consents
5. TYPES OF CONSENT
• Categorical
• Blanket Consent
• Opting Out
• No Consent
7. CHALLENGES
• Elements of informed Consent
• Confidentiality and Privacy Protection
• Participant Withdrawal
• Certificate of Confidentiality and G.I.N.A
• Consent for Future Use of Specimens
• Researcher Access to Data
• Large Scale Data Sharing
• Length of Time Specimens are Stored and Used
• Storage Consent
• Informing Participants of Research Results
13. REFERENCES
McGuire, A. L., & Beskow, L. M. (2010). Informed Consent in Genomics and Genetic Research. Annual
Review of Genomics and Human Genetics, 11, 361–381. http://
doi.org/10.1146/annurev-genom-082509-141711
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3216676/
Rothstein, M. A. (2005, Spring). Research Privacy Under HIPAA and the Common Rule. The Journal of
Law, Medicine & Ethics, 33(1), 154-159.
Retrieved from http://search.proquest.contentproxy.phoenix.edu/printviewfile?accountid=4 58
University of Phoenix student materials HCS/465. Electronic Reserve Reading. Retrieved from website
March 21, 2016 Clark, G. T., & Mulligan, R. (2011). Fifteen common mistakes encountered in clinical
research. Journal of Prosthodontic Research, 55(1), 1-6.
University of Phoenix. Retrieved ftom student material HCS/465. Steneck, N., (2007). Introducuction to the
Responsible Conduct of Research. Washington DC USA
Editor's Notes
Ethics in health care research must be understood and upheld. However, there are some situations when the understanding is not so clear. It can become complicated when people have different ethical perspectives and might not agree on what is right and what is wrong. Ethics are formed on people's interpretation of their life experiences and whatever personal values they have come to hold. Many institutions have chosen to write up ethical codes of conducts and policies for their employees to follow to ensure that everyone has a common viewpoint and understanding. It is however understood throughout the research community that informed consent is an ethical must, especially when dealing with human subjects. In some cases, there have been questions about the best way to obtain consent. Large scale population studies in genetics using human DNA have made it more challenging for researchers to get consent in the traditional way. The research community is tasked with finding the most appropriate way to obtain consent to avoid the consequences of ethical implications and protect research participants.
The Standards for Privacy of Individually Identifiable Health Information or the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA) regulates "protected health information" or PHI, defined as individually identifiable health information ( Rothstein, 2005).The Privacy Rule is misunderstood because it covers certain types of entities but not all. Health care facilities are not the only place that deals with PHI; there are also employers, schools, and other places. The Common Rule, which is federal regulation of privacy issues in research involving human subjects, was the central area of the federal rule for Protection of Human Subjects and pertains to researchers receiving federal financial support from a guarantor (Rothstein, 2005). The Common Rule and the Privacy Rule are supposed to work together and compliment in situations research privacy.
When most think of consent, informed consent is what comes to mind, during the consent portion of a study, the participants are given information about the purpose, procedures, confidentiality protections, risks, benefits and to make the decision to participate.
According to US National Library of Medicine (2011), there are many benefits and risk that can happen when storing DNA. If we do not have a valuable consent form from the patient to collect and store it there is a possibility of a potential lawsuit. One good thing about being able to store DNA to use for research is that they can identify disease-associated genes that will be stored for our future data. In doing this, we are less likely to see any physical risk to our patients that have signed the consent form for this to be done.
When using DNA as research for the future, we need to all be aware that it is undefined and could be misused information. For example, a patient signs a consent form for the storage of their DNA to be used for a cure for HIV and an employee stores their information in the wrong section, and it gets used for heart disease they will then end up with inaccurate readings. Making sure everything is identifiable and stored is critical in regards to the consents to our patients and how we use their DNA.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3216676/
According to US National Library of Medicine (2011) categorical consent- is giving the participant the opportunity to control the aspect on how the specimen is used in the research.
Blanket Consent- This is where the participant agree to leave their specimen for the future use at the time that it is collected which is sufficient for legal matters.
Opt-Out- “One way to preserve the right to refuse participation in genetic and genomic research without incurring the burdens of informed consent is through public disclosure and an opportunity to opt out of participation (US National Library of Medicine (2011).”
No Consent- This is where that they claim that there is no form of consent that would help the participant that gave over their specimen.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3216676/
Research Participants must be informed upon agreement - of what they will encounter in the process of a research study
We will get a blood sample from you
We will obtain health information from you
Your information will be stored in a Bio-bank along with your sample
Researchers will use the samples for approved studies
We may contact you in the future for other offers in further studies
Your genetic/health information may be placed in scientific databases
Biospecimen Collection is done by researchers during a clinical procedure. This is when participants should be informed if any extra tissue samples will be needed beyond what was already taken or if they will be using any of the remaining tissue samples after the current testing is complete. (We will be getting blood sample from you.)
Information Collection is where researchers will ask participants to answer personal information on questionnaires about their personal and family history, sex, age, and race/ethnicity (We will get some information about you and your health).
Storage is where researchers will explain how and where they will be storing the participants biospecimens and personal information. Remembering there is not a limit of time that the researchers will keep the specimens and information, unless the participants changes their minds and opt out of the research. (We will store you sample and information in the Biobank).
Researcher Access will establish guidelines for all samples and information collected and who will have approved access to the participants information. (We will let researchers use the material store in the Biobank for approved studies).
Recontact by researchers will happen if more samples are needed for the same study or they may want the previous participants to be used in a different study. (We may contact you in the future with offers to take part in other research).
Large-Scale Data Sharing is a centralized database that researchers will be explaining to the participants who will be able to see and use their information. (Some of your genetic and health information may be placed in scientific database).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3216676/
Storage Consent
Researcher Access to Data
Large Scale Data Sharing
Confidentiality and Privacy Protection
Participant Withdrawal
Certificate of Confidentiality – and G.I.N.A (pg. 20).
Informing Participants of Research Results
There will always be risks and challenges will doing any type of research. Researcher must make sure that they cover all obvious challenges such as elements of informed consent, consent for future use of specimens and length of time specimens will be stored and used.
It is important in research to minimize financial conflicts that may arise due to uninformed consent. “Financial conflicts of interest re situations that create perceived or actual tensions between personal financial gain and adherence to the fundamental values of honesty, accuracy, efficiency, and objectivity.” (Introduction to the Responsible Conduct of Research, pg. 69). With this in mind, it is important for researchers to be upfront and honest about any and all financial conflicts that could include costs or payments incurred by or owed to the participant, any commercialization that may occur because of the research, and any compensation due to the participant or researcher.
Informed consent is essential in all aspects of research and members should be informed of any and all costs or payments that may be potentially associated with participating in a research study, even DNA research (McGuire, 2010). Participants will also need to be informed if there is a potential that the research conducted could result in the development of commercial products (McGuire, 2010).
It is not uncommon in research to financially compensate a participant for their involvement. These compensations are generally a modest financial incentive ("Www.genome.gov", 2015). According to "Www.genome.gov" (2015), “…but researchers and IRBs should consider the risk of undue influence of such compensation on research participation.” (Financial Reimbursement, Costs and Commercialization).
Reference:
McGuire, A.L. (2010). http://www.ncbi.nlm.nih.gov/. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3216676/
www.genome.gov. (2015). Retrieved from https://www.genome.gov/27559024#_Financial_reimbursement,_costs
Researchers and Pioneers of medicine and health information technology should share values that dedicate themselves to truthfully conveying information and honor commitments. Report findings in the research study accurately, precisely, and without any errors. (Steneck, 2007). Utilize resources objectively and efficiently; avoiding bias by allowing the facts to speak clearly for themselves. (Steneck, 2007). Researchers have an ethical obligation to avoid and report misconduct when it occurs. (Steneck, 2007). Today, opinions and debates are the pulse of America. Opinions sound like "lub", and debates are the "dub" sound of the heartbeat in American culture. Without either one of those sounds of a heartbeat, immediately you know something must be wrong. In research, however, personal opinions can lead to bias, even if the opinions are based on beliefs that claim to adhere to moral and ethical standards. Personal opinions can lead to misrepresentation of the facts, selection bias, and other acts of Research misconduct.
Bias in Research can lead to misconduct. Misconduct is falsifying, and manipulating information in the process of the study, tampering with equipment; changing, or omitting data results, so that results are not presented to the public with accuracy and truthfully. (Steneck, 2007). According to (Clark & Mulligan, 2011), effective bias control measures are critical in research. Failure to implement bias control measures is the single most important error made in research. Bias control should include a “blinding status check.” (Clark & Mulligan, 2011). “Double blinding of researchers and subjects is desirable in clinical trials to control bias.” (Clark & Mulligan, 2011). “Bias Control” sets apart good research practices from the bad - when measures to control bias are put in place. The blinding status check (Clark & Mulligan, 2011), includes interventions in controlled settings, investigators that are blind to the subjects participating; measurement analysis, and other control measures.
The research community has recognized the difficulty in obtaining consent for human DNA use on a large scale. However, they know it is essential to obtain consent to protect the participants, their privacy, and their rights. Their response has been to come up with several distinct consenting methods that are appropriate for different types of collection, storage, and usage of the DNA that will also keep the patient informed about what will happen. Fine tuning these consents and making sure that they are detailed and informative will help keep the research from falling into ethical implications. Research is meant to better the community and the world around us. Many studies have helped save lives and made great changes in our community. Genetic research has the potential to do this as well, and that is why we must ensure that research is being carried out ethically. Every bit of information collected should count towards making a change.
