Responsibilities of Principal Investigators
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 protocol 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 protocol application. The Investigator Agreement /Unaffiliated Investigator Agreement is kept on file in the IRB office with the specific study file.
See also IRB-HSR investigator agreement
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
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.
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:
- all correspondence with the IRB and the sponsor (if applicable),
- documentation of subject eligibility, and
- a copy of the signed informed consent form (if applicable) obtained from all subjects participating in and/or who have participated in the protocol regardless of whether or not the subjects completed the study.
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 and confidentiality of all personally identifiable information of all human subjects participating in research, except as required by law or released with the written permission of the subject.
Those who conduct research under a UVa IRB approved protocol must develop a plan to protect the privacy and confidentiality of subjects.
Subjects have the right to:
- be protected against invasion of their privacy,
- expect that their personal dignity will be maintained, and
- expect that the confidentiality of private information will be preserved.
The more sensitive the research, the greater the care is required in obtaining, handling, and storing the data.
The conditions for maintaining confidentiality of the subjects and the 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 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 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:
- the sensitivity of the information involved,
- the possibility of identifying particular individuals, and
- the magnitude and probability of harms that may result from identification of research subjects.
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:
- assigning each research subject a code number and using that number on all data about the subject, and
- the use of locked rooms and filing cabinets for storage of data.
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.
In some instances, research results may be disclosed to
- government agencies,
- the research sponsor,
- the IRB or its designees,
- a regulatory agency, or
- those individuals who may be responsible for financial oversight at the institution where the research is conducted.
State statutes may require reporting of
- child abuse,
- sexually transmitted diseases,
- intent to murder, or
- suicidal thoughts.
In some cases it may be impossible to present the data without identifying the research subject. Examples include:
- those involving well-known individuals,
- those with very rare conditions, or
- research that requires presentation of photographs or videotapes.
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 encouraged to adopt the following principles in order to protect the confidentiality of subjects participating in research:
- Limit recording of personal information to that which is absolutely essential to the research.
- Store personally identifiable data securely and limit access to the principal investigator or authorized research assistants/associates.
- Code data as early in the research as possible, and plan for the ultimate disposition of the code linking the data to individual subjects.
- Apply for Federal Certificates of Confidentiality (see below) for all situations for which certificates are reasonable and available.
- Do not disclose personally identifiable information to anyone other than the research team without the written consent and authorization of the subjects or their legally authorized representatives. (Exceptions may be made in case of an emergency or as required by regulatory agencies.)
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 an advance grant of confidentiality, known as 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 only "when 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:
- Information relating to sexual attitudes, preferences, or practices;
- Information relating to the use of alcohol, drugs, or other addictive products;
- Information pertaining to illegal conduct;
- Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
- Information that would normally be recorded in a subject's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
- Information pertaining to an individual's psychological well-being or mental health.
- Information in other categories not listed may also be considered sensitive because of specific cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation.
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:
- where the referring and/or treating physician assures the project director that they have complied with reporting requirements; or
- where there is no referring and/or treating physician, the investigator has reached an agreement with the health department about how s/he will cooperate with the department to help serve the purposes of the reporting requirements (Unless the investigator can show why such cooperation is precluded; and
- only where disclosures of identifiable information about subjects comply with regulations on subject protection and are explained clearly to subjects prior to their participation.
IRB-HSR Procedures: Certificate of Confidentiality
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
The principal investigator is responsible for ensuring that s/he and any other co-investigators adhere to the principles and practices for the use of human subjects in research as set forth in Federal Regulation and this Guide including the reporting to the IRB of all know instances of non-compliance.
In the case of student research, it is the responsibility of the faculty advisor to ensure that the policies and procedures of this Guide are followed.
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
- abusive relationships,
- suicidal tendencies, and
- threats to harm others.
In such instances, the board will require that additional safeguards be put in place to protect vulnerable participants, such as:
- demonstrating ability to handle such situations,
- obtaining a Certificate of Confidentiality and
- providing specific plans for dealing with an incident.
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
- the signs of a harmful situation,
- your responsibilities for reporting a situation, and
- how to report.
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.
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:
- Persons licensed to practice medicine or any of the healing arts, hospital residents or interns, nurses, or duly accredited Christian Science practitioners
- Teachers or other persons employed in public or private schools, kindergartens, or nursery schools
- Persons providing childcare full-time or part-time for pay on a regularly planned basis
- Social workers, mental health professionals, or any person responsible for the care, custody, and control of children
- Probation officers, law enforcement officers, mediators, or court-appointed special advocates
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?
Any teacher or other person employed in a public or private school, kindergarten or nursery school is legally required to report child abuse. Beyond legal obligations, please consider your ethical obligation to protect your participants and protect children in general.
How do I report?
Each school district is responsible for developing protocol for reporting child abuse, so you should talk to the principal or school administrator about their policies. Albemarle County School District, for example, requires that the principal be notified about the incident. The principal will then contact the appropriate institutions, such as the Department of Social Services.
For more information about child abuse reporting requirements, please see the Code of Virginia.
Required template sections are built into Protocol Builder as applicable.
Domestic Abuse: Emotional, Physical, and Sexual Abuse of Adults
What is domestic abuse?
Domestic abuse can take many forms from the inward signs of emotional abuse and sexual abuse to the more obvious outward signs of physical abuse. As a researcher, you may encounter both the victim and the victimizer. The Women's Place at UVa has an excellent site that defines emotional, physical, and sexual abuse and provides information on the signs of abuse. This site can be a good resource to provide to your participants if you suspect they may be victims of 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.
Required template sections are built into Protocol Builder as applicable.
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: http://www.dss.virginia.gov/pub/pdf/aps_brochure.pdf
For more information, please see their website at http://www.dss.virginia.gov/family/aps.html .
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.
- Any person licensed, certified, or registered by health regulatory boards listed in § 54.1-2503, except persons licensed by the Board of Veterinary Medicine:
- Board of Nursing : Registered Nurse (RN); Licensed Nurse Practitioner (LNP); Licensed Practical Nurse (LPN); Clinical Nurse Specialist; Certified Massage Therapist; Certified Nurse Aide (CNA)
- Board of Medicine: Doctor of Medicine and Surgery, Doctor of Osteopathic Medicine; Doctor of Podiatry; Doctor of Chiropractic; Interns and Residents; University Limited Licensee; Physician Assistant; Respiratory Therapist; Occupational Therapist; Radiological Technologist; Radiological Technologist Limited; Licensed Acupuncturists; Certified Athletic Trainers
- Board of Pharmacy: Pharmacists; Pharmacy Interns; Permitted Physicians; Medical Equipment Suppliers; Restricted Manufacturers; Humane Societies; Physicians Selling Drugs; Wholesale Distributors; Warehousers, Pharmacy Technicians
- Board of Dentistry : Dentists and Dental Hygienists Holding a License, Certification, or Permit Issued by the Board
- Board of Funeral Directors and Embalmers: Funeral Establishments; Funeral Services Providers; Funeral Directors; Funeral Embalmers; Resident Trainees; Crematories; Surface Transportation and Removal Services; Courtesy Card Holders
- Board of Optometry: Optometrist
- Board of Counseling: Licensed Professional Counselors; Certified Substance Abuse Counselors; Certified Substance Abuse Counseling Assistants; Certified Rehabilitation Providers; Marriage and Family Therapists; Licensed Substance Abuse Treatment Practitioners
- Board of Psychology: School Psychologist; Clinical Psychologist; Applied Psychologist; Sex Offender Treatment Provider; School Psychologist - Limited
- Board of Social Work: Registered Social Worker; Associate Social Worker; Licensed Social Worker; Licensed Clinical Social Worker
- Board of Nursing Home Administrators: Nursing Home Administrator
- Board of Audiology and Speech Pathology: Audiologists; Speech-Language Pathologists; School Speech Language Pathologists
- Board of Physical Therapy: Physical Therapist; Physical Therapist Assistant
- Any mental health services provider as defined in § 54.1-2400.1;
- Any emergency medical services personnel certified by the Board of Health pursuant to § 32.1-111.5;
- Any guardian or conservator of an adult ;
- Any person employed by or contracted with a public or private agency or facility and working with adults in an administrative, supportive or direct care capacity;
- Any person providing full, intermittent, or occasional care to an adult for compensation, including but not limited to companion, chore, homemaker, and personal care workers; and
- Any law-enforcement officer .
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 diminshed 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.virginia.gov/pub/pdf/reporting_aps.pdf
Required template sections are built into Protocol Builder as applicable.
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:
- certified substance abuse counselor
- clinical psychologist
- clinical social worker
- licensed practical nurse
- licensed substance abuse treatment practitioner
- marriage and family therapist
- mental health professional
- mental health service provider
- professional counselor
- registered nurse
- school psychologist
- social worker
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:
- Breaching confidentiality with the limited purpose of protecting third parties by communicating the threats made by your client to potential third party victims or law-enforcement agencies or by taking any of the actions below.
- Failing to predict, in the absence of a threat, that the client would cause the third party serious physical harm.
- Failing to take precautions other than those described below to protect a potential third party victim from the client's violent behavior.
How do I report a threat?
The Code of Virginia states that doing one of the following actions will satisfy your duty to report:
- Seek involuntary admission of the client under Chapter 8 (§ 37.2-800 et seq.) of Title 37.2.
- Make reasonable attempt to warn the potential victims or the parent or guardian of the potential victim if the potential victim is under the age of 18.
- Make reasonable effort to notify a law-enforcement official having jurisdiction in the client's or potential victim's place of residence or place of work, or place of work of the parent or guardian if the potential victim is under age 18, or both.
- Takes steps reasonably available to the provider to prevent the client from using physical violence or other means of harm to others until the appropriate law-enforcement agency can be summoned and takes custody of the client.
- Provide therapy or counseling to the client or patient in the session in which the threat has been communicated until the mental health service provider reasonably believes that the client no longer has the intent or the ability to carry out the threat.
Required template sections are built into Protocol Builder as applicable.
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:
- Previous suicide attempt
- Mental disorders-particularly mood disorders such as
depression and bipolar disorder
- Co-occurring mental and alcohol and substance abuse disorders
- Family history of suicide
- Impulsive and/or aggressive tendencies
- Barriers to accessing mental health treatment
- Relational, social, work, or financial loss
- Physical illness
- Easy access to lethal methods, especially guns
- Unwillingness to seek help because of stigma attached to mental and substance abuse disorders and/or suicidal thoughts
- Influence of significant people-family members, celebrities, peers who have died by suicide-both through direct personal contact or inappropriate media representations
- Cultural and religious beliefs-for instance, the belief that suicide is a noble resolution of a personal dilemma
- Local epidemics of suicide that have a contagious influence
- Isolation, a feeling of being cut off from other people
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 Elson Student Health Center provides counseling and emergency care.
Required template sections are built into Protocol Builder as applicable.
Principal investigators have the responsibility of informing the IRB when a study has been completed.
A study is considered to be open and active until the investigator has submitted a Closure Form to the IRB.
Investigators will be notified by the IRB at least annually following the initial approval of the research. At these notification intervals, investigators are to submit either a continuation request or a Closure Form.
Faculty advisors for student research have the obligation to ensure that the Closure Form is filed with the IRB in a timely fashion.
When a principal investigator terminates employment or other association with UVA, he or she is obligated to submit a Closure Form to the IRB or formally transfer the protocol to another principal investigator via a modification which is reviewed and approved by the IRB. In very rare cases, the IRB may grant special permission for the departing individual to remain as principal investigator on the project. Cases are reviewed on a case by case basis.
A study may be closed when all of the following apply:
- All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing)
- All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained)
- No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary)
- Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors.
Please complete the Study Closure Form and submit it to the IRB within 30 days of closure of the study.
In order to close your IRB protocol officially, submission of Closure Form is required.
If you are leaving UVa, you are strongly encouraged to utilize the Exit Checklist.
The IRB maintains an official protocol file for each study to meet the University's regulatory obligations for record keeping. The IRB staff is not responsible for maintaining study documents for the researchers, or for providing copies of official documents to research staff. Keeping accurate and complete protocol records is the responsibility of the study team.
Record Retention by Study Teams at UVa
DHHS Regulated Studies
Requirements for record retention vary with
- the type of research conducted,
- provisions of the investigators funding source, and
- the requirements of the investigators professional association.
DHHS regulations do not clearly address the issue of the length of time a principal investigator should maintain research records after completion of all research activities related to a study.
Records should be kept a minimum of two (2) years after submission or publication of the final project report for which the data were collected, whichever is longer.
The guidance states that records should be kept a minimum of two (2) years after submission or publication of the final project report for which the data were collected, whichever is longer.
If a research study involves health information that was not de-identified, the records must be kept for six (6) years from the date the study was closed with the IRB.
If retention requirements specified in a funding agency's regulations are longer, the agency requirements will apply.
In addition, at the discretion of the investigator, some data may be retained longer for use in subsequent projects.
All records must be accessible for inspection and copying by authorized representatives of the IRB, regulatory agencies and sponsor.
FDA Regulated Studies
For studies regulated by the FDA, the investigator or sponsor shall maintain the records during the investigation and for a period of 2 years after the latter of the following dates:
- the date on which the investigation is terminated or completed, or
- the date that the records are no longer required for purposes of supporting a pre-market approval application or
- a notice of completion of a product development protocol.
An investigator or sponsor may withdraw from the responsibility to maintain records for the period required and transfer custody of the records to any other person who will accept responsibility for them including the requirements of 21CFR812.145. Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.
The following guidelines are provided to assist investigators and research staff with recordkeeping of approved IRB protocols documents and to facilitate submissions of correct versions of protocol documents for the life of the study.
Records to Keep While a New Study is Being Reviewed by the IRB
The study team should keep electronic files of all study documents (e.g., protocol, informed consents etc.) in order to make requested revisions that may be required for IRB approval.
Records to Keep Once a Study is Approved by the IRB
If applicable: Consent(s) with Approval Stamp. All copies of approved consents must be kept, however, only the most current approved version of the stamped consent form should be used to make copies of the consent for enrolling research participants.
All documents previously submitted to the IRB.
All documents received from the IRB.
The electronic file of the currently approved protocol and consent form(s) if applicable should be retained for future IRB submissions such as modifications or continuations.
Protocol Modification Submissions
- The study team must incorporate revisions into the most recently approved electronic file version of the protocol and consent form(s), and other protocol documents, as applicable.
- Note that some studies are modified frequently and the most recent approved version must always be used for each modification request.
- Versions checks of protocols and consent forms are performed routinely by the IRB staff. Revisions submitted on older versions of the protocol or consent cannot be reviewed by the IRB and will be returned for correction.
Continuing Renewal Submissions
- The study team must keep copies of all documents, including the Status Forms, submitted to the IRB at the time of the continuation review.
*Taken from UVa IRB-HSR Research Guidance