24-27. CITI Certification .pdf

Research and Biostatistics Masters of Arts in Biomedical Sciences CITI Certification: Parts I & II Meghan L. Wilson, PhD Assistant Professor Bluefield College: VCOM-VA Campus, Edward Via Virginia College of Osteopathic Medicine, 1691 Innovation Dr. Suite 1100, Blacksburg, Virginia 24060 (office) T...

Research and Biostatistics Masters of Arts in Biomedical Sciences CITI Certification: Parts I & II Meghan L. Wilson, PhD Assistant Professor Bluefield College: VCOM-VA Campus, Edward Via Virginia College of Osteopathic Medicine, 1691 Innovation Dr. Suite 1100, Blacksburg, Virginia 24060 (office) Telephone: 540-231-7761 Fax: 540-231-5338 [email protected] Made in collaboration with Dr. Jim Palmieri CITI Certification: Parts I & II Topics to be covered 1. 2. 3. 4. Research involving human subjects Rights as a human research subject Children as human research subjects People in highest risk groups as research subjects 5. Expectations being a human research subject 6. Recruitment, screening and consent 7. Who is protected (People agreeing to be a human recruitment subject) Research Involving Human Subjects • One of the requirements of study approval by the VCOM IRB is the completion of human subjects training by all personnel working on a research project, including those projects deemed to be exempt under 45.CFR.46.101. • All personnel is defined as those individuals responsible for the design and conduct of the research, data analysis or project reporting. • This includes investigators, clinical coordinators, those administering informed consent or surveys, laboratory staff and students. • Subcontractor personnel and consultants, as well as those outside individuals operating under VCOM’s FWA, must also comply with this educational requirement. • VCOM requires a refresher course to be taken every three years. Research Involving Human Subjects: VCOM CITI • VCOM utilizes Collaborative Institutional Training Initiative (CITI) as its training program. • VCOM provides access to the training course through CITI’s interactive online modules. • To begin the process, you must register on the CITI site and choose VCOM from the drop-down menu of participating institutions. • A PowerPoint presentation is available below that walks through the registration process as well as how to find your required course and how to start each module. • A completion report / certification for all study personnel is required as part of the IRB application submission. • An IRB submission will not be considered complete until a training certification is received for all personnel involved. Research Involving Human Subjects: VCOM CITI • https://about.citiprogram.org/en/homepage/ Rights as a Human Research Subject In 2010, the National Institute of Justice in the United States published recommended rights of human subjects: 1. 2. 3. 4. 5. 6. 7. 8. • • • • Voluntary, informed consent Respect for persons to be treated as autonomous agents The right to end participation in research at any time Right to safeguard integrity Benefits should outweigh cost Protection from physical, mental and emotional harm Access to information regarding research Protection of privacy and well-being Ethical guidelines that govern the use of human subjects in research are a fairly new construct. In 1906 some regulations were put in place in the United States to protect subjects from abuses. After the passage of the Pure Food and Drug Act in 1906, regulatory bodies were gradually institutionalized such as the Food and Drug Administration (FDA) and the Institutional Review Board (IRB). The policies that these institutions implemented served to minimize harm to the participant's mental and/or physical well being. Rights as a Human Research Subject: Nuremberg Code 1. In 1947, German physicians who conducted deadly or debilitating experiments on concentration camp prisoners were prosecuted as war criminals in the Nuremberg Trials. 2. That same year, the Allies established the Nuremberg Code, the first international document to support the concept that "the voluntary consent of the human subject is absolutely essential". 3. Individual consent was emphasized in the Nuremberg Code in order to prevent prisoners of war, patients, prisoners, and soldiers from being coerced into becoming human subjects. 4. In addition, it was emphasized in order to inform participants of the risk-benefit outcomes of experiments. Rights as a Human Research Subject: Declaration of Helsinki 1. The Declaration of Helsinki was established in 1964 to regulate international research involving human subjects. 2. Established by the World Medical Association, the declaration recommended guidelines for medical doctors conducting biomedical research that involves human subjects. 3. Some of these guidelines included the principles that "research protocols should be reviewed by an independent committee prior to initiation" and that "research with humans should be based on results from laboratory animals and experimentation". 4. The Declaration of Helsinki is widely regarded as the cornerstone document on human research ethics. Rights as a Human Research Subject: The Belmont Report The Belmont Report was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to describe the ethical behaviors that involve researching human subjects. 1. The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. 2. It is the responsibility of the researcher to inform the persons of the benefits as well as the risks of human subject research. Justice is important because it causes the researchers to be fair in their research findings and share what they have found, whether the information is good or bad. The selection process of the subject is supposed to be fair and not separate due to race, sexual orientation or ethnic group. Lastly, respect for persons explains that at any point a person who is involved in a study can decide whether they want to participate, not to participate or withdraw themselves from the study altogether. Two rules of respect for persons involve the person being autonomous and persons with diminished autonomy and entitled to protection. The sole purpose of these guidelines is to ensure autonomy and to protect against those with a lesser chance to remain autonomous because of something out of their control. 3. 4. 5. 6. 7. Children as Human Research Subjects • Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. • Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. • Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research. • Parent means a child's biological or adoptive parent. • Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. When a proposed research study involves children and is supported or conducted by HHS, the research institution's Institutional Review Board (IRB) must take into consideration the special regulatory requirements that provide additional protection for the children who would be involved in the research. There are four categories of research with children under Federal regulations: 1. No greater than minimal risk to children is presented. 2. The research involves greater than minimal risk to subjects with prospect of direct benefit to individual subjects. 3. The research involves greater than minimal risk to children presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, by a monitoring procedure which is not likely to contribute to the well being of the subject. 4. The research does not meet the requirement of any of the above categories, and the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children. Most research involving children falls under categories 1 and 3 but the IRB will determine whether the proposed research fits within the regulatory categories during the initial review using the justification provided by the investigator. Children as Human Research Subjects People in Highest Risk Groups as Research Subjects Seven traits identified by the National Bioethics Advisory Committee that may make an individual vulnerable: 1. Cognitive: may lack the ability to understand what consent means or what they are consenting to 2. Communicative: Those who are presented a consent form in a language they cannot read or presented with explanations in a language they do not understand. 3. Institutional: pertains to individuals who are under at least partial control of an institution, like students or prisoners. 4. Deferential: individuals who are informally subordinate to another person. In some cultures, women may defer to their husbands wishes for them to participate. 5. Medical: individuals who have serious health conditions for which there is no satisfactory treatment. 6. Economic: may happen when participation is sought from individuals who lack basic necessities like housing, healthcare, and money. 7. Social vulnerability: pertains to those research subjects who may be seen as less respected or “less-than” because of social position. In many instances, one individual may possess more than one trait of vulnerability. Expectations Being a Human Research Subject The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as: dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. Research that involves human subjects or participants raises unique and complex ethical, legal, social and political issues. Research ethics is specifically interested in the analysis of ethical issues that are raised when people are involved as participants in research. Expectations Being a Human Research Subject There are three objectives in research ethics. • The first and broadest objective is to protect human participants. • The second objective is to ensure that research is conducted in a way that serves interests of individuals, groups and/or society as a whole. • The third objective is to examine specific research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent. Expectations Being a Human Research Subject • A human subject is defined by DHHS as a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information. • Informed consent is about people's understanding and willingness to participate in your study and not about signing a form. • Prospective participants in your research study must understand the purpose, the procedures, the potential risks and benefits of their involvement, and their alternatives to participation. Many or even most ethical codes cover the following areas: • • • • • • • • Honesty and Integrity Objectivity Carefulness Openness Respect for Intellectual Property Confidentiality Responsible Publication Legality Recruitment, Screening and Consent: Recruitment Strategy The researcher and the IRB must consider the following ethical concerns when evaluating a recruitment strategy: • • • • • Respect for privacy Lack of pressure Unbiased presentation of the study Avoiding the therapeutic misconception Conflicting concerns of care providers and patients Also keep the following principles in mind when developing your recruitment strategy: • • • • Avoid initial contact by "unknown" individuals Restrict medical record access Minimize use of PHI (Protected health Information) Exceptions to these principles may be granted where necessary. The IRB application must explain why exceptions are necessary; approval is not automatic. Recruitment, Screening and Consent • Informed consent is a process that begins with the recruitment and screening of a subject and continues throughout the subject's involvement in the research. • Documentation of consent provides a record that the consent process took place and is often used as a tool for engaging in the consent process • The waiver or alteration of any or all of the elements of consent can be authorized if the following four criteria are met: • The research involves no more than minimal risk to the subjects, the waiver or alteration will not adversely affect the rights and welfare of the subjects, • the research could not practicably be carried out without the waiver or alteration or whenever appropriate and the subjects will be provided with additional pertinent information after participation. • Ensuring Comprehension of Consent Information: Reading level, language issues, cultural issues and presentation Recruitment, Screening and Consent Who May Recruit Individuals initiating contact (in person or by phone) with potential subjects must have basic knowledge about the study (so they can answer questions) and training in the voluntary nature of research participation. • They also should be prepared to provide prospective subjects with • A researcher’s name and phone number (for questions about the study) and • the phone number of the IRB (for questions about a research subject’s rights). The IRB’s usual policy is that patients identified through chart review should be approached by someone already involved in their care. Recruitment, Screening and Consent • Recruitment refers to the overall process of attracting and selecting suitable candidates for a project. • Recruitment of subjects represents the beginning of the informed consent process and is one of the most challenging parts of research with human subjects. • Recruitment can be conducted through newspapers, email, posters, brochures, by internet, radio or television announcements, or by soliciting volunteers in public spaces. • The pressure to enroll subjects, especially in biomedical research, raises ethical challenges for investigators and research staff. • All recruitment efforts must respect personal rights to privacy and confidentiality and be compliant with applicable regulations (FDA, OHRP, and HIPAA). Recruitment Materials When a project requires IRB review, all recruitment materials must be reviewed as part of the study. Recruitment materials generated by USC research personnel must be submitted to the IRB for review and approval before they can be used. • Recruitment materials should include: • Accurate description of the research purpose • Name and address of the investigator or facility (including university affiliation and/or department) • Condition under study or purpose of the research • Eligibility criteria • Time commitments required • Location of the research • Person to contact for further information Recruitment Materials Recruitment materials should not include: • Coercive language • Claims that a device or drug is safe and effective • The words “new treatment,” “new medication,” or “new drug” if the test article is investigational • Promises of “free medical treatment” • Amount of payment, dollar signs, or the words “free” in large or bold face type • Compensation should not be excessive relative to the nature of the project • Statements or implications assuring favorable outcome or other benefits beyond what is outlined in the consent document and protocol • Claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic, or device • Exculpatory language • Articles and Guidance on Recruit Special Consideration for Projects Involving Vulnerable Populations There are a number of research populations described in the Federal regulations as vulnerable or that require additional consideration or protection. "Vulnerable" or "special" classes of subjects include: • • • • • • • • • Pregnant Women, Human Fetuses And Neonates, Prisoners Children Cognitively Impaired Persons Students And Employees Minorities Economically And/Or Educationally Disadvantaged Aids/Hiv+ Subjects. Terminally Ill Subjects • • • • Fetuses, Pregnant Women, and In Vitro Fertilization Prisoners Children In Addition, The Regulations Outline Specific Provisions For Research Involving: Vulnerable Subject Populations In reviewing research projects, the IRB determines if the inclusion of the vulnerable population is adequately justified and that safeguards are implemented to minimize risks unique to each population. During it's review the IRB must determine which of the following categories the research would involve: • The research does not involve more than minimal risk to the subject; • The research is likely to benefit the subject directly, even if the risks are considered to be more than minimal; • The research involves greater than minimal risk with no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition; or • Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of the subject. Vulnerable Subject Populations Requests for approval of any research that exposes vulnerable populations to risks that do not meet one of the previously mentioned criteria must be submitted to the United States Secretary of Health and Human Services for review and approval. • Special protections are essential to guide research involving vulnerable persons. • In order to review projects involving the use of vulnerable populations as specified in 45CFR46, an IRB must have present at its meeting an advocate for these subjects. • The mere presence of the appearance of vulnerability should not lead to a presumption that a person is incapable of making a decision regarding participation in research and of giving valid informed consent. • Yet sometimes these conditions do impair the decisionmaking capacity required to give a valid informed consent, raising ethical concerns about the vulnerability of persons in such conditions in research.