Revised on: 1/17/2023
This chapter defines the role of Principal Investigator, co-investigator, and student investigator in human subjects research. Additionally, it identifies the specific responsibilities, qualifications, and interactions of an investigator.
The term Principal Investigator (PI) implies specific responsibilities and interactions with subjects and staff in conducting research. Investigators have a responsibility to protect the rights and welfare of participants, and following applicable federal, state, and local regulations. Investigators are expected to follow ethical principles and standards appropriate for their discipline and research. Investigators are expected to follow Good Clinical Practice (GCP) guidelines in designing and conducting clinical trials. The PI bears ultimate responsibility for the scientific, technical, and administrative aspects of the research project, even when tasks have been delegated to co-investigators, sub- investigators, staff, or students. USC policies, procedures, and education programs are provided to help investigators carry out research studies ethically. Refer to Section12.3 – Educational Requirements for training requirements.
Who may be a Principal Investigator on an IRB Application
It is the responsibility of the individual investigator to know the requirements and limitations of the Principle Investigator role, set forth in both USC Policy and USC HRPP Policies and Procedures.
At USC, the following may be listed as Principal Investigator in iStar:
- Faculty that meet “Requirements of Principal Investigators for Grant Management” as stated below, may serve as PI for studies receiving external funding, such as support from the Department of Health and Human Services (including NIH) and awards granted from federal agencies.
- USC faculty and staff (excluding temporary personnel) may serve as PI for studies that are not funded, and do not require management of funds by the Department of Contracts Grants (DCG) or the Clinical Trials Office (CTO).
- For studies that are of greater than minimal risk or require full board review – the PI must hold a full time faculty position.
- “Students” may include undergraduates, master and doctoral students, medical students, residents/interns, clinical, research and postdoctoral fellows. Student investigators must designate a Faculty Advisor on the IRB application. Faculty Advisors are responsible for the scientific and ethical quality of student research projects. For more information, see Section 12.7 – Faculty Advisor’s Assurance for Student Investigators
Requirements of Principal Investigators for Grant Management
For grant management, principal investigators can only include:
Tenured, tenure track, and Research, Teaching, Practice, and Clinical (RTPC) faculty, and research scientists (with the exception of lecturers, adjunct, and part-time clinical faculty) may act as Principal Investigators. Voluntary faculty may not serve as Principal Investigators. Retired faculty may be called back and asked to serve as Principal Investigators as described in Section 10 of the Faculty Handbook. Postdoctoral Research Associates and Postdoctoral Teaching Associates, as defined by USC’s Postdoctoral Scholars Policy, may act as co-principal investigators on sponsored projects, but may not be principal investigators unless a specific waiver and approval is granted upon recommendation by the Department and approval of the appropriate Dean. To review the Postdoctoral Scholars Policy, please visit https://policy.usc.edu/postdoctoral-scholars/.
- All investigators must have current grants management training (verified at time of award)
- All investigators supported by Health and Human Services (including NIH) must have submitted a current conflict of interest disclosure and have current conflict of interest training (verified and required prior to proposal submission)
- All investigators supported by federal agencies must have a signed “present assignment” of intellectual property to USC and must have agreed in writing to promptly disclose inventions resulting from their research (verified at time of award).
For additional information search for the Guide to Research at USC and the Postdoctoral Scholars Policy on the Office of Research website.
Guidance_Who May Be A Primary Investigator 6.04.2020
IRB Review of Investigator Qualifications
One of the responsibilities of the IRB is to determine that the investigator is appropriately qualified to conduct and supervise the proposed research. In many cases, previous experience with an investigator allows the IRB to readily determine an investigator’s qualification. However, if the IRB has no knowledge about an investigator, the IRB may request additional documentation to evaluate an investigator’s qualifications (such as curriculum vitae, medical licensure or relevant publication). The IRB may also need to assess an investigator’s training specific to the proposed study, particularly if the research involves higher risk, vulnerable subjects or novel technologies.
USC investigators are hospital affiliated and credentialing is provided by the Office of Integrated Credentialing, Keck Medicine of USC. Investigator qualifications and research is reviewed and approved by the associated department chair.
Principal Investigator Responsibilities
The PI initiates the research proposal, defines the scope of the work, controls the conduct of research, and directly supervises any others (faculty, staff, or students) involved in the research. The PI is responsible for all expenditures under a grant (if applicable). The PI certifies the percentage of effort for other faculty and staff working on the project, certifies the accuracy of charges, notifies and communicates with sponsor personnel and collaborating organizations as needed, and manages the orderly execution and close out of the project.
Investigator Responsibilities to IRB
PIs are responsible for ensuring that research is conducted according to valid research design and methods. PIs must adhere to an IRB approved study plan (protocol) and terms of the grant, contract and/or signed funding agreements as well as applicable laws, regulations, and institutional policies.
Investigators must provide in the IRB application that adequate facility, staffing and relevant resources are available for the research that is under review.
Initial Study Responsibilities
Prior to commencing research PIs must:
- Obtain approval from the appropriate department, institute and Dean or designee of the school for any proposal to be submitted to the IRB. Some schools (such as the Keck School of Medicine) require additional approvals, for example, from a Division Chief.
- Ensure appropriate research compliance/ancillary committee approvals as deemed necessary. Studies may require school or department approvals as determined by the particular school or department, or other committees as deemed necessary.
- Submit an application for IRB review and approval. All IRB applications must be submitted through the iStar system.
- Provide and maintain a current list of Key Personnel in the IRB submission application through the iStar system. Departments may not impose names of staff as “key personnel” unless it adheres to the following policy.Key Personnel“Key personnel” listed on an IRB application must include only the following individuals:
- Creating, contributing, or initiating, in a substantive, measurable way to a new research project whether or not they ultimately receive salaries or compensation from the study,
- conducting research through an interaction or intervention with human subjects for research purposes,
- participating in the consent process of a research study,
- directly recording or processing identifiable private information related to subjects for the purpose of conducting the research study
The following must not be listed on an IRB application as key personnel*:
- Individuals paid by the institution/department to perform a service, but are not part of, or paid by, the research project,
- individuals performing a service typically performed for non-research purposes,
- fee for service activities/functions
- an honest broker who provides IRB approved data or specimens to a
- pharmacy employees dispensing study drugs,
- hospital employees who routinely collect and provide specimens
- radiology clinic employees performing radiological imaging (x-rays, CT
scans, MRI’s, ultrasounds, PET Scans, etc.),
- laboratory employees providing routine laboratory analyses of blood samples for investigators as a commercial service,
- transcription service employees providing transcriptions as a commercial service,
- individuals not administering any study intervention being tested or evaluated under the protocol
*The IRB will remove those listed who do not meet submission requirements.
Note: If research initiated at another Institution will be continued at that Institution and/or transferred to USC, the investigator must contact the USC IRB for information and submission requirements.
Individuals paid by the institution/department to perform a service, but are not part of, or paid by, the research project, individuals performing a service typically performed for non-research purposesIndividuals paid by the institution/department to perform a service, but are not part of, or paid by, the research project,
Ongoing Study Responsibilities
PIs must keep the IRB informed about their study and are required to:
- Submit annual progress reports when required by the to the IRB. (see Section 8.2– Continuing Review)
- Submit an amendment to the IRB if a change to an IRB-approved study is necessary. The IRB must review and approve the changes before these are implemented unless the change to the study is initiated to prevent an immediate hazard to subjects (see Section 8.1 – Amendments – Changes to Research after Approval)
- Submit reportable events and reports to the IRB as applicable. Reportable events and reports include adverse events, unanticipated problems involving risks to subjects, protocol deviations, data safety monitoring reports, and protocol changes initiated to eliminate immediate hazard to subjects (see Section 6.12 – Reportable Events and Section 6.13 – Reports)
Close Out Study Responsibilities
PIs must submit a final progress report to close out a study when a study is completed or terminated (see Section 8.3 – Project Closure). PIs who plan to leave USC and have active studies are required to:
- Close the study/ies: investigators must submit a final progress report (Continuing Review in iStar) or complete the “Close Study” activity in iStar
- Transfer the study to another USC investigator: submit an amendment to change the Principal Investigator
- Transfer the study to another Institution: investigators must close the study at USC by submitting a final progress report (Continuing Review in iStar) or complete the “Close Study” activity in iStar
- Continue study at USC and at another site: investigator should contact the USC IRB for more information and guidance.
Investigator-Initiated research has many different meanings. The National Institute of Health (NIH) uses the term “investigator-initiated research” to describe an investigator submitting an application to the NIH on a topic of his or her choice. Investigator-initiated research differs from targeted research in which investigators respond to an institute’s call for applications in research topics specified in requests for applications (RFA) or requests for proposals (RFP).
Investigator-initiated research, in the context of clinical trials with an IND or IDE, is when an investigator is also considered the sponsor (sponsor-investigator) and must fulfill all regulatory requirements, FDA expectations, and monitoring expectations of a sponsor. This differs from studies initiated and funded by a sponsor in which the sponsor provides the protocol. In addition to FDA regulations, sponsor-investigators must comply with California laws that affect research sponsors, such as manufacturing regulations for experimental drugs and devices. For additional information, refer to the California Health and Safety Code Sections 111515-111545 and 111550-111610.
The iStar application requires investigators to indicate when the IND/IDE is held by USC faculty or investigator. Sponsor-investigators must also complete the Sponsor- Investigator attestation in iStar when submitting their study to the IRB. Investigators who plan to conduct sponsor-investigator research should contact the IRB Chair for assistance. For more information refer to Section 16.4 – Sponsor-Investigators.
Certification Requirements for USC IRB Submission
The USC IRB requires that applicable certifications for Good Clinical Practice (GCP), Human Subjects Research Protections, and Research HIPAA courses must be current and not due to expire within 30 days from the IRB submission. If certification will expire within 30 days, iStar will automatically indicate an expiration warning for personnel added or presently on a study when a new submission, amendment, or continuing review is being prepared and prohibit submission.
All human subjects applications (exempt, expedited and full board) require all study personnel listed in section 2.1 to have current human subjects certificates; all studies that meet NIH’s definition of a clinical trial require all study personnel to have current Good Clinical Practice certificates and all studies that accessing protected health information (PHI) require all study personnel to have successfully completed USC’s Research HIPAA certification course.
Human Subjects Protections Training
To obtain IRB approval for human subject research protocols, all study personnel must complete human subjects training. The online course used is provided by the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org, providing a certificate of completion valid for three years.
Prior to a certificate expiring, a notification is sent from iStar to the researcher. Study personnel who have completed the human subjects basic course must renew their certification every three years. A refresher course is provided on www.citiprogram.org.
Human subjects training is not required for studies that are considered Not Human Subjects Research (NHSR). Grant/Contract Only (CG) submissions and Coded Specimens/Data are not considered human subjects research.
Requests to transfer GCP, and/or Human Subjects training certifications from outside Institutions or vendors will be evaluated to determine that course content is equivalent to USC CITI course requirements prior to being accepted.
For CITI educational requirements, refer to the OPRS website.
Good Clinical Practice (GCP) Training
Good Clinical Practice (GCP) represents the international ethical and scientific standard
expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
GCP training is required for all PIs and staff on studies meeting the NIH definition* of clinical trials (as of 2015). GCP “refresher training”, mandated in 2016 regulations, must be completed every three years after completion of the initial training. Sponsors of research may require additional GCP training.
GCP training is intended for study staff who collect data through intervention or interaction with a subject, or have access to private identifiable information however, anyone on the study team may be asked to take it at the request of the IRB.
USC provides GCP online courses for initial and refresher training through CITI. For more information, contact the OPRS at (213) 821-1154 or visit the OPRS website.
*A clinical trial means a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. (46.102)
Research HIPAA Course
The “Privacy Rule” also known as the Health Insurance Portability and Accountability Act (HIPAA) establishes minimum Federal standards for safeguarding the privacy of individual identifiable health information.
USC researchers and staff who use or access protected health information are required to complete the Research HIPAA course offered online through CITI. A refresher course is required every three years.
Responsible Conduct of Research
Training courses in the Responsible Conduct of Research are offer various entities. Funding agencies may require specific training course. All students (including undergraduates, graduate students, and postdoctoral scholars) supported by the National Science Foundation are required to complete an approved course in Responsible Conduct of Research. Students supported on certain NIH programs, including training grants, are also required to complete RCR training.
Information regarding, funding agency requirements for completion of Responsible Conduct Research courses and training resources can be found at the following website:
No person is allowed to perform medical procedures at USC without being properly credentialed /licensed and have the required hospital privileges. Persons with a foreign medical degree/license are not credentialed /licensed to perform medical procedures in California.
Credentialing for licensure is the responsibility of the Office of Compliance.
The IRBs may require new PIs (first time submitters) to provide a copy of their curriculum vitae and medical license, and if necessary, additional supporting information to document that the investigator is qualified to conduct the research activity.
Procedures for USC Investigators conducting multi-site research at USC as well as non- USC sites are described below. This only applies to full board and expedited studies. See also Responsibilities Defined under the FWA.
The following procedures are for review and oversight of multi-site, non-exempt research.
IRB Review of Resource Adequacy
Once an investigator submits a new IRB application, it undergoes an administrative review by an IRB staff reviewer to ensure the application is complete. Upon initial review of the application, the staff reviewer ensures that the PI has listed any organizational units/departments/committees that are involved in the conduct of the research and that the investigator has secured approval from each department. If there are any organizational units that have not been listed, or the PI has not secured appropriate approval, the staff reviewer will send correspondence via iStar to the PI informing them that approval from the organizational units/departments/committee must be obtained prior to IRB approval.
Once a new study is submitted to the Full Board for review, it is the IRB committee’s responsibility to ensure that the Investigator has listed the organizational units/departments/committees that are involved in research and have secured their approval. If during the IRB’s consideration of the study the investigator has not obtained approval, the IRB must stipulate that such approval be obtained prior to IRB approval. Additionally, the IRB considers whether resources are adequate to conduct proposed research. For example, if the research involves specialized medical equipment or staff, the IRB may ask the investigator to confirm that such resources are available to conduct the research.
Site Permission in Multi-Site Research
A USC investigator who conduct non-exempt research at non-USC sites and is engaged in research is required to obtain permission to conduct research when the site itself is not “engaged” (refer to Section 3.1 – Engagement in Research). All sites must be listed in the iStar application. The investigator is responsible for obtaining and maintaining a copy of a letter of permission for each site in the study. The addition of a site after initial approval must be submitted in an amendment.
A permission letter is necessary to ensure that relevant information regarding the proposed research has been shared with, and agreed to, by the appropriate agency/institutional authority. The institutional authority is someone who has signatory authority (such as a Principal, clinic Director, school board Chair, or superintendent) for the organization. The investigator is responsible for obtaining and maintaining a copy of the letter of permission for each site in the study. A template letter is available on the OPRS website: Research Site Permission Template.
Waivers may be granted for minimal risk research and certain social behavioral studies.
Common Reasons for Waiving the Site Permission Requirement:
- Obtaining site permission is not practicable
- The research is being conducted at a large number of sites
- The data being collected is anonymous
- The behavior studied is not related to site/place
- The study involves less than minimal risk
Common Reasons for NOT Waiving the Site Permission Requirement:
- Research involves greater than minimal risk
- Safety concerns for participants or researchers
- Permission is required by the site (such as LAUSD, health clinics, hospitals)
- Amount of time and effort required to obtain permission is minimal, and a courtesy
- Subjects are vulnerable and permission letters are usually required (children, cognitively impaired populations) (See Chapter 13 – Vulnerable Subject Populations)
Multicenter Clinical Trials and Centralized IRB Review Process
A centralized IRB review process involves an agreement under which multiple study sites in a multicenter trial rely in whole or in part on the review of an IRB other than the IRB affiliated with the research site.
21 CFR 56.114, Cooperative Research – provides that, “institutions involved in multi- institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.”
NIH Single IRB (sIRB) for Multi-Site Research
The single IRB (sIRB) mandate is an NIH policy that requires certain types of NIH- supported studies involving multiple sites where each site will conduct the same protocol involving non-exempt human subjects research to use a single IRB to accomplish IRB review and approval for all domestic participating sites.
The NIH policy applies to grant applications received on or after January 25, 2018.
- NIH Policy on the Use of a Single IRB (sIRB)
- Requisites for Single IRB
HHS and NIH policies requires documentation in the form of an agreement which may be an MOU, Master Reliance Agreement, Authorization Agreement or similarly named.
USC as Coordinating Center for Multi-Site Research
When USC is the coordinating center for a multi-site study, an adequate plan for the management of information from all sites relevant to the protection of participants is required. This plan should include:
- A description of the types of events to be reported (such as unanticipated problems involving risks to subjects or others, adverse events, noncompliance, significant new information or findings, required protocol modifications)
- When the reports must be made and sent to the coordinating center
- How to make the reports to the coordinating center (specific forms, IRB
- To whom the reports should be made (such as lead investigator, other)
- The process for disseminating these reports to the non-USC sites
- A description of how the coordinating center will ensure that each participating non-USC site has obtained IRB approval before initiating research activities
- A description of the types of events to be reported (such as unanticipated problems involving risks to subjects or others, adverse events, noncompliance, significant new information or findings, required protocol modifications)
It is the Lead PI’s responsibility to submit an adequate management and communication plan in iStar for research being conducted at multiple sites.
Data Coordinating or Statistical Center Responsibilities
This type of application places emphasis on how the Lead PI will assume responsibility for collection, storage, management and statistical analysis of data collected.
- Designing data forms
- Providing instruction on use of the forms
- Managing data and statistical analysis
- Overseeing secure data transmission and storage
- Protecting confidentiality of data and ensuring its integrity
- OHRP: “Guidance on Engagement of Institutions in Human Subjects Research”
- Using a Centralized IRB Review Process in Multicenter Trials
- OHRP: “Guidance on Engagement of Institutions in Human Subjects Research”
The term “conflict of interest” in this policy refers to situations in which financial, or other personal considerations compromise, or have the appearance of compromising, an individual’s professional judgments in proposing, conducting, supervising or reporting research. Conflicts of interest include non-financial as well as financial.
(See “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought”)
Conflicts of Interest may include but are not limited to the following:
- Equity (stocks or options, do not include mutual funds)
- Recruitment incentives, bonus payments, (these are prohibited)
- Consulting Fees
- Speaking Fees
- Travel Reimbursement
- Corporate Officer or Board of Directors
- Other Employment Relationship
- Licensing Agreements
- Royalty Payments
- Patent Holdings
Conflicts of interest must be declared in the IRB application when the study investigators, research personnel, or their immediate family/domestic partner have a financial interest, and/or intellectual property interest in the sponsor or products used with the project, equal to or exceeding $5,000 per year. Investigators must also inform the IRB of relationships with the sponsor or party with economic interests in the research such as consultation agreements, speaker services or management roles. When these relationships exist, the potential conflict of interest is reviewed by the Office of Compliance.
HSS requires an annual financial disclosure for researchers who are proposing or have received HHS funds (including NIH, CDC, HRSA, and AHRQ) regardless of whether any of these interests give rise to a conflict of interest related to their research. The annual disclosure must be completed before a proposal can be submitted to HHS, and any identified conflicts must be managed before an account can be established. In addition, all HHS-funded investigators must complete training on conflicts of interest once every four years.
All potential or actual conflicts of interest must be disclosed online using the diSClose system.
The Conflict of Interest in Research Committee (CIRC) evaluates disclosed, or (knowingly or unknowingly) withheld, conflicts of interest.
For additional information regarding Conflict of Interest, refer to the USC Office of Culture, Ethics and Compliance website.
When a student investigator is listed as the PI on the IRB application, a full-time faculty member must also be listed as the faculty advisor.
It is the responsibility of the individual investigator to know the requirements and limitations of the Principle Investigator role, set forth in both USC Policy and USC HRPP Policies and Procedures. Refer student investigators to: 12.1 Who may be a Principal Investigator on an IRB Application.
Visiting faculty (e.g., professor, researcher) may not serve as faculty advisor.
The faculty advisor electronically approves/ signs-off on the IRB application to indicate they have reviewed the submission, it is ready for IRB review, and the faculty advisor assumes responsibility for oversight of the student’s research.
The faculty advisor certifies that the student investigator is knowledgeable about IRB policies, and applicable federal regulations governing research with human subjects, and has sufficient training and experience to conduct the study in accordance with the approved protocol.
Waiver of Full-Time Faculty Status to Serve as Advisor for Research
Generally, only those who have a full-time academic appointment may serve as Faculty Advisor. However, there may be circumstances when individuals who do not have an academic appointment or full-time status may be the best person to oversee a student’s research. In such cases, a Waiver of Full-Time Faculty Status to Serve as Advisor for Research Proposal must be requested. The waiver is limited to studies that are no greater than minimal risk; any studies that are greater than minimal risk, and require Full Board Review, will require a full-time academic appointment at USC.
All personnel listed in the iStar application must adhere to USC requirements for iStar accounts and educational certificates (Human Subjects, Good Clinical Practice and Research HIPAA).
If the candidates FA does not have a full-time academic appointment with USC, the candidates FA must request an iStar account and submit the fully executed waiver to the iStar tech support (email@example.com) with the request to assign the FA role in iStar.
Once the function has been activated, and all current certificates have been uploaded into their iStar profile, the candidates FA can be listed in Section 2.1.
The candidate is required to upload the fully executed waiver into Section 40.1 of the iStar application, prior to submitting the application to the IRB.
The Human Research Protection Program (HRPP) has implemented a mandatory human subjects education program for all investigators, including students. Faculty advisors are considered key personnel and are required to complete Human Subjects Training and Good Clinical Practice Training and Research HIPAA (if applicable). Courses are available at CITI (citiprogram.org). Faculty advisors must ensure that student investigators and all other key personnel have completed the required training. The faculty member is also responsible for the scientific quality of the student research project submitted to the IRB.
A student investigator must electronically sign the IRB application. This means they agree to meet with their faculty sponsor on a regular basis to monitor study progress. If the faculty advisor is away, the student investigator will meet with the arranged alternate faculty advisor who will assume responsibilities.
The student investigator is expected to be familiar with the policies contained in USC’s Federalwide Assurance(s). Prior to initiating research activities, student investigators must complete the Human Subjects Education Program (CITI).
IRB approval must be obtained before conducting human subjects research, publishing or presenting the data. Undergraduate honors papers, master’s theses, and dissertations that are human subjects research require IRB review.
The IRB may not approve applications where an investigator circumvents IRB policies and procedures by collecting data as a “non-research” activity, and then subsequently applying for IRB approval to analyze the data as existing data. It is in the investigator’s best interest to carefully consider the likelihood of the data being used for future research purposes and err on the side of caution in seeking IRB approval prior to commencing the work. The IRB does not grant retroactive approval.
The University of Southern California is committed to maintaining an environment that promotes high ethical standards in the conduct of research. The University does not tolerate misconduct in any aspect of research and will deal with misconduct associated with research forthrightly in accordance with academic due process, and with respect for practices commonly accepted within the scientific community.
Scientific misconduct is defined by the federal government as the fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Human subjects review does not include evaluation of possible scientific misconduct. Other university committees make these determinations. If there is reason to believe scientific misconduct has occurred in a human subject research project, the IRB will report it to the appropriate official.
At USC, allegations of research misconduct, involving human subjects, are reported by the IRB to the Vice President of Research, the Director of the Office for the Protection of Research Subjects (OPRS), and the Senior Associate Vice President of the Office of Compliance, and General Counsel Office for further action (scientific misconduct is not the purview of the IRB).
If a USC investigator does not conduct research responsibly, according to federal regulations or University policy, the investigator is subject to both federal and USC oversight. USC is committed to fairly and uniformly investigating and reporting all instances of alleged or apparent misconduct involving research by members of the University community, regardless of the funding source. For information on how these issues are handled by the University, refer to the USC Policy on Scientific Misconduct.
The Responsible Conduct of Research section of the OPRS websites contains links to information on the responsible conduct of research and tutorials on how to conduct research responsibly and ethically.
The investigator is required to document that adequate resources have been allocated for the research. In addition, the department head must indicate that the submission has been reviewed to assure that the investigator has the necessary knowledge and privileges to perform the study, and that sufficient resources and adequate funds are available to perform the study as described in the submission. The IRB may not grant approval of the research until this documentation is complete.
It is the investigator’s responsibility to identify all departments and organizational units that will be involved in the conduct of the research. The IRB may require ancillary approvals in addition to those identified by the investigator. Ancillary approvals are authorizations from units/departments/committees whose services are critical to implementation of the research.
All investigators who intend to publish in an International Committee of Medical Journal Editors (ICMJE) journal must register their study in ClinicalTrials.gov., regardless of whether the study is a clinical trial or social behavioral study. The registration requirement applies to “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”
The FDA / NIH and CMS (Center for Medicare and Medicaid Services) require study registration for all “applicable clinical trials”.
You must register in clinicaltrials.gov before study begins. All researchers doing health outcome studies must register in clinicaltrials.gov. For additional information about study registration for clinical trials, refer to Section 16.12 – Registration of Clinical Trials and Other Types of Research.
Mandated reporters are individuals who are obligated by law to report suspected cases of child and/or elder abuse and neglect. In general, any person who has contact with children or the elderly in a professional capacity is a mandated reporter, although laws vary from state to state, as does the legal entity to which reports must be made. USC policies and procedures covering mandated reporters and the reporting of abuse/neglect can be found at the following site. Appendix A of the above policy provides a list indicating who are considered mandated reporters. See also USC policy on Protecting Minors.
For the California Penal Code definition of mandated reporter see Elder Abuse and Dependent Adult Civil Protection Act Section 15630 (a) and Child Abuse and Neglect Reporting Act Section 11165.7.
Abuse Disclosure Notification in Consent Documents
Disclosing the obligation to report certain types of neglect and abuse in the informed consent process is only required for research projects involving mandated reporters. However, even though the requirement to report only applies to mandated reporters, Section 11166.05 broadens the scope of possible reporting beyond the mandated areas by allowing (not requiring) mandated reporters to make reports regarding children suffering from “serious emotional damage or… at a substantial risk of suffering serious emotional damage, evidenced by states of being or behavior, including, but not limited to, severe anxiety, depression, withdrawal, or untoward aggressive behavior toward self or others”. This should be addressed in the informed consent process.
Reporting of Positive Results of Communicable Disease Testing
Any individual having knowledge of a person who is suspected to be suffering from one of the diseases or conditions (link to Title 17, Section 2500) may make such a report to the local health officer for the jurisdiction where the patient resides.
The manner and timing of reporting obligations varies depending on the communicable disease to be reported. In the event a report may be necessary; the investigator must immediately contact the IRB or the Office of Compliance for further guidance.
The following link provide specific reporting information:
Reporting Observed/Suspected Injuries in Research
California Penal Code 11160
Child Abuse and Neglect Reporting Act
California Penal Code 11165
Elder Abuse and Dependent Adult Civil Protection Act
California Welfare and Institutions Code 15601
Elder Abuse and Dependent Adult Civil Protection Act Section 15630 (a)
If research involves a study population where there is an established risk of suicidal ideation there is need for identification and management of the potential for suicide. Study participants who express suicidal intentions present a delicate situation that requires attention and referral to a qualified clinician. The wellbeing and best interests of the research participant must always be maintained throughout a study.
Participants and the Potential for Suicidal Risk
The possibility of suicidal ideation or risk for suicide in an individual participant may not always be known in advance. For this reason, guidance is offered for assuring safety for both unexpected suicide risk and suspected suicide risk among research participants. In such circumstances standard mental health measures should be used in research to evaluate suicide risk.
The research team may receive information that suggests that a participant might be suicidal. If a participant reports that he/she is considering suicide, the research team is then responsible for timely and appropriate follow-up to assure the safety of that participant. It is essential that a plan to ensure that timely and appropriate follow-up of research participants who are at increased risk for potential suicide is included in the research protocol and or IRB application. Researchers are encouraged to develop procedures, using the general guidelines, applicable to their particular research protocols.
Protocols that include the following elements require a management plan in the event suicidal ideation is identified:
- Questions regarding suicide as part of the testing, interview, or assessment protocol.
- Subject sample or research procedures that involve elements of depression or suicide risk, such as research on mood disorders, severe mental disorders, self- mutilation, debilitating illnesses, or use of a chemotherapy agent that is known to be associated with an increase of depression.
Assessment of Suicidal Ideation
- Intentional assessment of suicidal ideation, through questions posed during an interview, assessment, or administration of a measurement instrument, such as the Beck Depression Inventory, due to the nature of the research. If the question is posed, either by interview or questionnaire item, be prepared to quickly review and further evaluate a positive response. The suicide question or positive response should be reviewed immediately or as soon as possible, rather than weeks or months after the data collection. This is not applicable in cases of collecting anonymous data when there is no direct subject contact, such as anonymous web-based questionnaires or questionnaires returned by mail without identifying information.
- Unintentional assessment of suicidal ideation may be revealed through disclosure on the part of subjects in those research projects involving subject populations or procedures that may be associated with mood disorders or in populations where it is not expected.
Elements of Assessment
Have clinicians or trained interview/data collection staff gather additional information1 to evaluate lethality or imminent danger to self and guide intervention.
- If the person collecting the data or conducting the interview is a trained clinician, that is, a psychologist, nurse practitioner, psychiatrist, clinical social worker, or the like, then the clinician gathers his or her own information and can act on the information as clinically indicated, (assuming the clinician has experience with managing suicide risk).
- If the person is not a clinician or is not familiar with suicide risk management, then a system, (including a list of readily available trained clinicians) should be in place to gather the necessary information about lethality and/or contact the appropriate clinician or make an appropriate referral for further evaluation and treatment.
An adequate assessment of lethality or imminent danger to self should, at minimum, include gathering information about the specific thoughts of suicide, whether or not the person has a plan, determine if the person has the means to carry out the plan, history of suicide attempts, family history of suicide; the person’s mental health history, history of use of medication, alcohol or illicit substances that may lead to lowering of inhibitions, and the person’s family or community support system.2,3,4
1 Information collected to evaluate lethality or imminent danger should not be included in research records.
2Bongar, Bruce (2002). The Suicidal Patient: Clinical and Legal Standards of Care. Washington D.C.: American Psychological Association.
3Jacobs, Douglas G., M.D., Editor (1999). The Harvard Medical School Guide to Suicide Assessment and Intervention. San Francisco, California: Jossey-Bass Publishers.
4Simpson, Skip, J.D. and Stacey, Michael, J.D. (May 2004). Avoiding the malpractice snare: documenting suicide risk assessment. Journal of Psychiatric Practice, 10(3), 1-5.
- All staff should be trained on how to assess for suicide risk and the emergency procedures to follow in the event someone is deemed at imminent risk of suicide. Giving research subjects a list of referrals or telling the subject to go to a hospital after disclosure or endorsement of seriously thinking about suicide would not be considered sufficient standards.
- If the interview or data collection is conducted by non-clinicians or research assistants, clinical research staff should be readily available either in person, by phone, or pager response.
- If the person is evaluated as high risk for suicide, the research staff should act quickly to protect the safety of the subject. This may mean staying with the subject until assistance arrives or the person is transported to a hospital.
For non-clinicians, the emergency system should outline procedures for contacting research clinicians for guidance, or in the event that clinicians are not available or cannot be contacted, the services of LAC+USC Medical Center Emergency Psychiatric Evaluation – 24-hour clinic and 911 are both available for response.
- For any results less than imminent risk, research clinicians should be available to assist in developing a plan for safety with the subject. The plan for safety will depend on the level of risk and available resources.
It may include contacting the person’s personal physician, making sure the subject has appropriate referrals with a plan to contact subjects as a means to evaluate the subject following through with the referrals, encouraging the person to talk to trusted family members or other community support resources, or giving the subject suicide hotline information.
For example, the clinician decides that although the subject has endorsed suicide ideation, there is no intent or plan, nor history of suicide attempts, but the subject does have bouts of depression. The clinician or clinician representative may provide the subject with referrals for treatment and the Suicide Prevention Hotline number or discuss contacting the subject’s primary physician or trusted family member to garner support or assistance.
Documentation of the assessment and procedures ultimately followed is important.
Informed Consent Language
Inform the subjects about what will happen if they express suicidal ideation and, in particular, if they are deemed to be an imminent danger to self by way of the research informed consent process. This information would ordinarily go in the confidentiality section of the consent form or information sheet. Below is sample wording regarding the issue.
The research team may not be able to keep confidential any disclosure or endorsement of thoughts to harm yourself. In the event that you tell the research staff that you are thinking about killing yourself or you answer yes to a question about having thoughts about suicide, the research staff will ask you more questions about the thoughts. Depending on how intense your thoughts are or how much you feel like hurting yourself, the research staff may provide you with referrals for treatment, work with you to contact your personal physician, trusted family member, or therapist to discuss your thoughts of harming yourself; or work with you on a plan that may include getting you to a hospital for safety.
Adverse Event Reporting and suicidal ideation
Adverse event reporting in research on suicide or depressed individuals needs to be tailored to the individual study. If the study involves individuals with a high risk of suicide, then a suicide would not be an “unexpected” event. Other criteria may exist, such as a hospitalization – which may require the need for IRB submission in such a case. In a study without inherent need for monitoring for depression or mood changes, a suicidal event would be unexpected, and therefore potentially reportable. Do not hesitate to contact the IRB for guidance on this issue.
Helpful Information and Links
- L.A. County/USC Medical Center, 1-323-226-5581: Full service psychiatric medical center. Outreach team gives referrals and evaluations for hospitalization and provides other mental health services.
- Suicide Prevention Hotline, 1-877-727-4747 or 1-877-7-CRISIS or 1-310- 391- 1253: operates 24hrs a day 7 days a week. Part of Didi Hirsch Community Mental Health Center which includes adult, family, emergency, and substance abuse services. For more information follow: http://www.suicidepreventioncenter.org/
Investigators are ultimately responsible for the conduct and safety of their research staff (including themselves). Faculty members are also responsible for safety of student researchers. Therefore, guidance for what constitutes appropriate and professional behavior must be provided before research begins. To reduce the likelihood of risks to their research team, investigators should provide training and a written management plan for staff who work in environments presenting high risk for injury. A good safety plan will include rules for behavior, safety and emergency situations.
Investigators are required by regulation to report “unanticipated problems involving risks to subjects or others” to the IRB (see Section 18.2 – Unanticipated Problems Involving Risks to Subjects or Others). “Others” is widely interpreted to include members of the research team; thus, IRBs must evaluate risks to study staff as well as to subjects when approving a study.
The IRB may also require safety plans/guidelines be submitted and will review the adequacy of such plans before approving the research.