Which of the following are the responsibilities of the principal investigator of a study?
Responsibilities of Principal Investigators Show
Background Investigators should be aware of certain, specific responsibilities that are required when conducting research. Plans for human research should reflect careful and unhurried consideration on the part of the investigator, in terms of what questions he/she proposes to answer and the precise methodology needed to obtain those answers. Although most investigators are familiar with some of the paperwork requirements associated with research, there are many reporting requirements which are often overlooked by investigators until problems are encountered with respect to a certain research activity. It is important for investigators to prepare and maintain clear documentation of research activities in an attempt to minimize or alleviate unnecessary confusion which may arise during the performance of research and during the course of routine audits carried out by the IRB, the FDA or other sponsoring or regulatory bodies. The Investigator signs an Investigator Agreement and submits this to the IRB with the new study application. If a sub-investigator /coordinator on the protocol is not a UVA employee, they should sign an Unaffiliated Investigator Agreement and submit this to the IRB with the new study application. The Investigator Agreement /Unaffiliated Investigator Agreement is kept on file in the IRB office with the specific study file. Qualifications of Principal Investigator The University of Virginia IRB's have set criteria for determining who may be the Principal Investigator on grants and protocols.
IRB Required Submissions Please refer to Types of Submissions to the IRB. Conflicts of Interest In the preparation of the protocol the researchers should carefully consider whether a conflict of interest exists. The IRB requires that conflicts of interest be fully disclosed in the protocol and the informed consent and that they be carefully explained. Researchers should also explain how the potential conflict of interest will be managed, reduced or eliminated. Federal guidance and University of Virginia policy require that all conflicts of interest be revealed to potential research subjects in the subject consent form. Additional management strategies may also be required based a review of the conflict of interest to the Conflict of Interest Committee. Financial Conflict of Interest The researchers will submit information regarding conflict of interest per the individual school policies. Financial conflicts of interest occur when one or more researchers have a significant financial interest in the research which is proposed. Significant financial interest does not refer to receiving funding to cover the costs of conducting the research. Rather, a conflict of interest exists when an independent observer may reasonably determine that the significant financial interest may affect or appear to affect the design, conduct, management or reporting of the research. The following are examples of situations considered to involve a conflict:
The following are examples of situations considered not to involve a conflict.
Research Files Maintained by Study Teams Principal Investigators are required to maintain a research file. A research file may consist of paper, electronic and/or other media. The requirements for a research file include, but are not limited to:
The file will act as the investigator's documentation regarding proper performance of the study. This information may be reviewed by the IRB, Federal or local authorities, sponsors, and other authorized individuals to ensure proper performance of the study. Faculty advisors are required to maintain research files for student research completed under their direction. Privacy and Confidentiality Investigators are required to maintain and protect the privacy of subjects and protect the confidentiality of all personally identifiable information, except as required by law or released with the written permission of the subject. Those who conduct research under a UVA IRB approved study must develop a plan to protect the privacy of subjects and confidentiality of their data. Subjects have the right to:
The more sensitive the research, the greater the care is required in obtaining, handling, and storing the data. The conditions for maintaining the privacy of the subjects and the confidentiality of their research records are required for the life of the data. Identifiable Personal Information No single item (except possibly a person's Social Security Number, which by law cannot be used except for very specific circumstances) can be relied upon to identify an individual with certainty. Names, addresses or telephone numbers may more directly identify an individual than postal codes, date of birth, age, occupation, initials, hospital or student number, ethnic group or religion. Although individual items may not by themselves permit identification of an individual, taken together in a given context and with a certain amount of effort and use of other sources, a combination of items may allow an individual to be identified. This means that all items of information relating to an individual may have the potential to identify that individual. Privacy Privacy is the right of persons not to share information about themselves. Researchers have a duty to respect the privacy of prospective subjects. That is, the researcher allows the research subject to determine when, how, and to what extent information about him or her is communicated to others. Researchers usually protect an individual's right to privacy by obtaining free and informed consent before collecting personal information about him or her. The act of contacting potential subjects to seek free and informed consent to access private information may constitute a breach of privacy if the investigator does not have access to such individuals in the course of his or her usual professional activities. In general, someone the research subject would think has a reason to know why he or she might participate in the study should be the first to approach the research subject or that person should be identified in any communication to a potential subject. Confidentiality Confidentiality is the obligation to keep private information that has been collected from being shared with others. Researchers have a duty to respect the confidentiality of personal information collected during research. Research projects vary substantially in:
Breaches in confidentiality may also have a negative impact on family and friends or the group to which the research subject belongs. The researcher has a duty to protect research subjects from harm through unauthorized release of identifiable personal information. Confidentiality safeguards include:
Anonymity When information collected through research is disseminated, research subjects normally are de-identified, unless identification has been agreed to or requested by the research subject. Often, data are presented in aggregate form which also reduces the potential to link specific responses to individuals. Limits In some instances, research results may be disclosed to
State statutes may require reporting of
In some cases it may be impossible to present the data without identifying the research subject. Examples include:
Research subjects need to be aware of any limitations to anonymity in these situations. In other cases, research records may be liable to subpoena in judicial and administrative proceedings, and data may be vulnerable to search warrants. Because researchers have a duty to protect the confidentiality undertaken in the free and informed process to the extent possible within the law, it is legitimate for the researcher and the institution to argue the issue in court. In fact, this may be the only legal option open to a researcher to protect the confidentiality of research data. Guidelines for Protecting Confidentiality Investigators are required to protect the confidentiality of research data according to University and Health System Policies, Guidance and Procedures. These are specified in the Data Security Plan and in the protocol or application. Certificates of Confidentiality Data collection about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual practices or preferences) requires the protection of confidentiality beyond preventing accidental disclosures. Under Federal law, researchers can obtain a Certificate of Confidentiality that will provide protection against compulsory disclosure, such as subpoena, for research data. The Certificates of Confidentiality were developed to encourage participation in research by granting certain protections to a subject divulging possible compromising information. The Certificates, however, do not exempt investigators from performing ethical research nor do they allow investigators to abdicate the responsibility to act in the public good. Therefore, investigators are required to include a statement in the consent form that alerts potential subjects of the legal and ethical mandate compelling researchers to report certain criteria. The investigator should delineate in the IRB protocol any conditions under which confidential information might be disclosed and create an informed consent document that accurately reflects those conditions, including any voluntary disclosure by the researcher. The IRB is required to determine whether the risks to subjects are minimized, informed consent is appropriate, and privacy and confidentiality protections are adequate. Certificates are issued automatically for any study that is federally funded and includes the collection of identifiable information. Researchers may apply through the NIH or FDA for a Certificate of Confidentiality for a study that is not federally funded if the research is of a sensitive nature where the protection is judged necessary to achieve the research objectives. The Public Health Service policy defines "sensitive" research as involving the collection of information falling into any of the following categories:
Additional policy considerations apply to research that involves the collection of data that relates to communicable diseases. The Assistant Secretary of the Department of Health and Human Services has issued a policy granting certificates of confidentiality to projects that "intend routinely to determine whether its subjects have communicable diseases and that are required to report them under State law." Certificates will be issued:
IRB-HSR Procedures: Certificate of Confidentiality Student Researchers Some projects assigned to students in a class may have a research component or constitute training as research methodology. If such projects are intended to contribute to generalizable knowledge (e.g., through publication or dissemination outside the classroom), they are required to undergo IRB review and approval. Classroom projects that are exclusively for instructional purposes need not undergo review by the IRB. Instructors and students are encouraged to follow Federal and University policy when designing and conducting class projects with human volunteers. Student initiated research involving human subjects, whether dissertation, thesis or other research projects, must be supervised by a faculty advisor and submitted to the IRB for review. IRB review and final approval must take place during the proposal stage of the dissertation or thesis. For more information from IRB-HSR see Student Researchers (info copied below-srh) Especially for Student Researchers FAQ's for Student Researchers I'm a UVA student interested in conducting my own research project. Do I need IRB approval before I can begin? Yes. Students conducting human subject's research require IRB approval before they can initiate their project. See Definition of Human Subjects Research to determine if your research meets the definition of Human Subjects Research. Please consult with the IRB staff if you are unsure whether your project constitutes human subjects research. Can I be listed as the Principal Investigator on the IRB Application? If you are submitting to the IRB for Health Sciences Research: No-a student may not be a PI when submitting to the IRB-HSR. If you are submitting to the IRB for Social and Behavioral Sciences IRB: Yes-UVA students may be the Principal Investigator on human subjects protocols as long as they have a Faculty member as an advisor. Should I submit a new IRB application, or be added to my Faculty Advisor's protocol? When a student's research project consists of the collection and/or analysis of data that is part of the scope of an existing faculty member's IRB approved research, the student can be added as a study team member on the Faculty member's protocol, rather than submitting a new IRB Application. The student must take the required education (see Education) and notify the IRB of their addition prior to beginning work on the protocol. Read more FAQ's Additional Information for working with the Center for Global Health and the IRB Learning Shot: Center for Global Health and the IRB Website: Center for Global Health Opportunities Additional Tips for Student Researchers
Non-Compliance Reporting For information on non-compliance reporting see Non-Compliance Reporting Participants in Harmful Situations: Abuse, Suicide, and Threat of Harm Researchers often work with participants who are at-risk for harmful situations in an effort to understand the participants' circumstances and research ways to improve their situations. However, such study designs are more likely to lead to disclosures about
In such instances, the board will require that additional safeguards be put in place to protect vulnerable participants, such as:
However, please note that these situations can become evident in studies that would not normally be considered "at-risk". Although the IRB may not require steps for dealing with a participant in a harmful situation, consider how you will handle a situation should it arise. Please become familiar with
These situations are often complicated and delicate. If you are concerned about a situation and need further guidance, please consider contacting other individuals experienced in handling these kinds of situations. In some situations, you may not have the expertise to best help an individual in crisis and it would be appropriate to refer the participant to someone who can help them. If your study involves public schools, please see the public school policy section for additional information. Public schools have more specific guidelines for dealing with a crisis situation. Child Abuse If your study involves children, especially if you are working intimately with them, there is always the possibility that you could discover evidence of child abuse. It is important to make yourself aware of the signs of child abuse, your reporting responsibilities, and where to report any suspicion. If you are working with at-risk minors, you will need to demonstrate that you are qualified and capable of working with this population, as the Board views these children as particularly vulnerable. What is child abuse? For an excellent explanation of child abuse and signs of abuse, please see the Prevent Child Abuse Virginia website. If you are an educator or will work in a school system, Virginia Commonwealth University has published an online training site for educators. Although this site is focused on educators, any researcher working with children could benefit from this training. What are my responsibilities to report child abuse? The Code of Virginia states that the following individuals are legally obligated to report signs of abuse:
As a researcher, you may fall into a category that makes you legally obligated to report suspicions of abuse. Failure to report can result in a fine. Regardless of your legal responsibilities, the Board asks that you act in the best interests of the child. Your ethical responsibilities as a researcher are explained in the Belmont Report. In the "Respect for Persons" section, it states that "persons with diminished autonomy are entitled to protection." In the "Beneficence" section, it states that "Persons are treated in an ethical manner by making efforts to secure their well-being." In your work with children, please seek to secure their well-being by being aware of their situations and where there may be a potential for harm to them. Depending on your expertise, it may not be appropriate for you to council an abused child or to become involved in the family's situation; in some cases, inappropriate action may put the child in a dangerous situation. Please contact the necessary authorities if you are concerned about a child's safety and seek advice from those who are experienced in handling such situations. Who do I contact if I suspect child abuse? To report suspected abuse or neglect call the department of social services in the locality in which the child lives or where the alleged abuse has occurred (Charlottesville Social Services: 434-970-3400). You may also call: Virginia Child Abuse and
Neglect Hotline If you feel that the child is in immediate and severe physical danger, call Child Protective Services (Charlottesville CPS: 434-970-3400) and/or local law enforcement immediately (Charlottesville Police Department: 434-977-9041). If you are working with a child through a public school, there may be additional reporting protocol required by the school. Public School Reporting Policies for Child Abuse Who should report? How do I report? For more information about child abuse reporting requirements, please see the Code of Virginia. Domestic Abuse: Emotional, Physical, and Sexual Abuse of Adults What is domestic abuse? In this section, the discussion of abuse is meant to cover on-going events, or the suspicion of an event that has already occurred. In the event that you become aware of an immediate and specific threat to harm someone, you may have legal obligations to report the event to the authorities. What are my responsibilities to report domestic abuse? As a researcher, you do not have specific legal responsibilities for reporting abuse. However, you should consider the well-being of your participants and act in their best interests, as stated in the Belmont Report. Often these situations are delicate and require experienced individuals to council the participant. If you do not have certified experience in helping an abused individual, do not council your participant or become involved in the situation. Inappropriate action may put the participant at greater risk. As you are working with an adult, the more appropriate step may be to refer the participant to resources that can help them, such as a hotline or shelter (as the situation warrants) instead of simply calling the police. However, if you become aware of a specific and immediate threat to harm your participant, or if your participant expresses intentions to harm another, you should contact the appropriate authorities. Please note that mental health service providers have a duty to take precautions to protect third parties from violent behavior or other serious harm when a specific and immediate threat to cause serious bodily injury or death has been communicated. What should I do if I suspect domestic abuse? Providing a list of resources for the participant to use is one way to respond to suspicions of domestic abuse. For research focusing on such issues, the Board will require that a list of resources be provided to all participants in the study. The Women's Center Sexual and Domestic Violence services has a list of hotlines and community contacts on their website. They also provide a third party anonymous reporting mechanism for campus related incidents. Elderly and Adults with Diminished Capacity Abuse The abuse of the elderly and adults with diminished capacity can take many forms including sexual assault, physical abuse, emotional abuse, and financial abuse. The Adult Protective Services (under the Virginia Social Services office) provides the following pdf document highlighting the signs of abuse: https://www.dss.virginia.gov/files/division/dfs/as/aps/intro_page/prevention_month/activities_resources/fact_issue.pdf For more information, please see their website at http://www.dss.virginia.gov/family/as/aps.cgi . For additional information, please see the following article: http://www.helpguide.org/mental/elder_abuse_physical_emotional_sexual_neglect.htm What are my responsibilities to report elderly and adults with diminished capacity abuse? Although researchers are not specifically listed as a legally obligated reporter, there is a lengthy list of responsible parties.
As a researcher, you may fall into a category that makes you legally obligated to report suspicions of abuse. Failure to report can result in a fine. Regardless of your legal responsibilities, the Board asks that you act in the best interests of the participant. Your ethical responsibilities as a researcher are explained in the Belmont Report. In the "Respect for Persons" section, it states that "persons with diminished autonomy are entitled to protection." In the "Beneficence" section, it states that "Persons are treated in an ethical manner. by making efforts to secure their well-being." In your work with the elderly and adults with diminished capacity, please seek to secure their well-being by being aware of their situations and where there may be a potential for harm to them. Depending on your expertise, it may not be appropriate for you to council an abused adult or to become involved in the family's situation; in some cases, inappropriate action may put the adult in a dangerous situation. Please contact the necessary authorities if you are concerned about an adult's safety and well-being. Who do I contact if I suspect elderly and adults with diminished capacity abuse? The Adult Protective Services (under the Virginia Social Services office) has a hotline for reporting abuse: 1-888-832-3858 For more information, please see the following pdf document: http://www.dss.cahwnet.gov/cdssweb/entres/forms/English/SOC341.pdf Specific and Immediate Threats to Cause Bodily Injury or Death to a Third Party What is a Threat? During your interaction with a participant, you may learn of a specific and immediate threat to hurt or kill someone. A threat can vary in degrees of serious intent. A participant may casually complain about someone and threaten physical harm without the serious intent of hurting anyone. The Code of Virginia states that if a mental health care provider "reasonably believes, or should believe according to the standards of his profession, that the client has the intent and ability to carry out that threat immediately or imminently" then the mental health care provider should act. This section discusses the general responsibilities of researchers and mental health care providers. If you are conducting your study in a public school or among students, please see public school policy for more information about the legal responsibilities and protocol for reporting threats and illegal behaviors. What are my responsibilities to report a threat? Mental health care providers are legally responsible to report a threat. The Code of Virginia defines a mental health care provider as the following:
Although the code does not specifically list researchers, the participant may be considered a client or patient in your care. If the third party is a child, you have additional obligations to protect the child from physical and sexual abuse in general. Please see Child Abuse for more information. You are not held liable for failing to report a threat if one of the following apply:
How do I report a threat? The Code of Virginia states that doing one of the following actions will satisfy your duty to report:
Suicide Threat The Surgeon General stated that there are far more suicides per year than homicides (over 50%), and suicide is the ninth leading cause of death. According to the Surgeon General, there are certain groups more likely to attempt suicide, specifically those with mental and/or substance abuse disorders, but suicide victims include the entire spectrum of population from children to the elderly. Some risk factors are:
What are my responsibilities to report a suicide threat? As a researcher, you do not have specific legal responsibilities for reporting a suicide threat. However, you should consider the well-being of your participants and act in their best interests, as stated in the Belmont Report. Often these situations are delicate and require experienced clinicians to council the participant. If you do not have certified experience in helping a suicidal individual, do not council your participant or become involved in the situation. Inappropriate action may put the participant at greater risk. As you are working with an adult, the more appropriate step may be to refer the participant to resources that can help them, such as a hotline or mental health clinic (as the situation warrants) instead of simply calling the police. However, if you become aware of a specific and immediate threat of harm to your participant, you should contact the appropriate authorities. If you are working in a public school system, there is specific protocol for reporting suicidal behavior. Please see the public school policy section for more information. How do I report a suicide threat? If your participants are at-risk for expressing suicidal intentions, you will need to have protocol in place to provide immediate assistance. For example, should a participant express suicidal intentions, or discuss suicidal thoughts and feelings, an experienced clinician should be available to assess the individual's state and refer them to the appropriate resources for help. Please note that some surveys and instruments, such as the BDI-II, ask participants if they have suicidal thoughts and feelings. Even though suicide may not be the topic of your research, if you are asking these questions of participants, you need to have a protocol in place for addressing affirmative answers. If a participant has expressed suicidal intentions and you do not have the protocol or expertise to handle this situation, please refer the participant to qualified individuals. For example, if the participant is a UVA student, the UVA Student Health Center provides counseling and emergency care. Closing a Study and Record Retention For information on steps to follow to close a study and requirements for record retention, see information found at Closing a Study and Record Retention What does the Principal Investigator in a study do?The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships.
Which of the following are GCP responsibilities of the investigator?What is GCP?. Ensures that the rights, safety, and well-being of study participants are protected.. Ensures the integrity of the data submitted for approval.. Sets standards for a system of mutual accountability among sponsors, regulatory authorities, investigators, and IRBs.. Which function is an investigator responsible for?21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement (the FDA's 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the ...
What is Principal Investigator?Co-Principal Investigator
An individual working in partnership with the Principal Investigator in the management, development and/or execution of the project. A co-investigator typically devotes a specified percentage of time to the project and is considered key personnel.
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