Completing the Annual Principal Investigator Worksheet
OVERVIEW
This Quickguide provides instructions for completing the Annual Principal Investigator Worksheet.
BEFORE YOU BEGIN
- Consider printing a copy of the Worksheet by clicking here to use as reference as you complete the Worksheet in IRBManager.
- The Worksheet should be completed by the Principal Investigator (PI) or PI’s designee.
- You will use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to make any changes to the auto-populated information relating to the person submitting and the PI. For more information, go to Updating Your CIRB Person Roster.
- If you are an NCI Division of Cancer Prevention (DCP) Consortia or CP-CTNet site, go to Navigating The CIRB For NCI Division of Cancer Prevention Consortia Sites And Cancer Prevention Clinical Trial Network (CP-CTNet) Organizations for information on how processes vary for you.
INSTRUCTIONS
The PI or designee should answer all the questions on the Annual Principal Investigator Worksheet found in IRBManager.
The first time you complete the Worksheet, check the box indicating that this is a first submission. You’ll indicate revised submission in subsequent Worksheets submitted after initial approval.
COMPLETE THE SIGNATORY INSTITUTION INFORMATION QUESTIONS
- Question 1: This field indicates the PI associated with this Worksheet. The email address entered must be the one associated with the PI in RUMS.
- Question 2: Select the institution associated with this submission. In most cases, only one is available in the dropdown selection for the PI. If a PI is associated with more than one institution, be sure to select the one associated with this submission.
COMPLETE THE RESEARCH STAFF QUESTIONS
- Question 3: Select the number of sub-investigators who will be enrolling participants in the studies opened by this PI.
- Question 4: Select the number of research nurses or Clinical Research Associates who will be supporting the PI in the studies opened by this PI with the CIRB.
- Question 5: Assess the financial conflict of interest. PIs are responsible for reporting any financial conflict of interest for themselves and for any member of their research team to the CIRB with an appropriate management plan.
COMPLETE THE PRINCIPAL INVESTIGATOR RESOURCES QUESTIONS
- Question 6: This is an auto-populated listing of CIRB approved studies open with this particular PI.
- Question 7: Select the number of study participants currently receiving study intervention on all studies the PI has opened with the CIRB. This number should not include study participants who are in long-term follow-up. It should pertain only to the participants actively receiving study intervention.
COMPLETE THE RECRUITMENT QUESTIONS
- Question 8: Select all the different recruitment methods used by this PI.
NOTE: Any recruitment materials developed locally must be submitted to the CIRB for approval prior to use. Network-supplied recruitment materials are approved by the CIRB and posted to CTSU. Only if changes are made to the content of these materials do sites need to submit to the CIRB for approval via a Study-Specific Worksheet.
- Question 9: For CIRB-studies, select how study participants are being identified.
COMPLETE THE COMPENSATION TO STUDY PARTICIPANTS QUESTION
- Question 10: Indicate whether there are any local forms of compensation provided for study participants that are NOT being offered to non-study participants. Examples of compensation include free parking or lunch vouchers.
COMPLETE THE INFORMED CONSENT PROCESS QUESTIONS
- Question 11: The discussion with the potential study participant should take place in a private location. Select and/or describe the private location where the potential study participant is approached to discuss the study.
- Question 12: Per FDA guidance, if a PI delegates the responsibility of the consent interview, then the individuals should be qualified by education, training, and experience to perform this activity. Select each person permitted to obtain consent.
- Question 13: Select each person who is available to answer the potential study participant’s questions.
- Question 14: Confirm that each potential study participant has as much time as needed to review the consent document before a response is required, including time to take the consent document home to review and discuss with others. Potential study participants should not feel pressured to sign the consent form.
- Question 15a: Indicate how the assessment of an individual’s understanding and competence is made by the PI or research team. It is important that the individual who provides consent is able to understand the study that is being presented to them.
- Question 15b: It is important that the individual who provides consent is assessed to determine if they are impaired and if they have the capacity to make a fully informed decision about participant in the study or if they require the assistance of a legally authorized representative (LAR). The potential participant should be assessed for alertness, memory, language, visual-spatial skills, and whether the potential participant can distinguish between past and present.
- Question 16: If an individual does not speak English, select and/or provide the process for determining whether or not to approach the individual about participating in a study and how the consent process will be conducted with that individual. Select the short forms that may be used at your Institution.
- Question 17: Consent should always be obtained by the potential study participant. Some studies allow a legally authorized representative (LAR) of an adult to consent for them or a parent of a child to consent. If your PI will enroll impaired adults or children, select the individuals who will be able to consent. The answer to this question affects the information needed for Questions 19, 24, and 26.
- Question 18: Some PIs have a patient population who do not speak English. If the PI enrolls study participants who do not speak English, select those languages that are used frequently enough to require translated consent forms. Provide the process for obtaining those translations.
- Question 19: Select if this PI enrolls impaired adult study participants, pediatric study participants, both or neither. If Question 17 indicated that the PI will allow legally authorized representatives and parents of potential pediatric study participants, describe how assent is obtained from the adult or minor study participant.
NOTE: The CIRB makes a determination regarding the requirement for assent and the age determination. Institutions enrolling children must obtain assent from any child in the age range determined by the CIRB. Local policy determines the documentation of the assent and should be described here. If a child in the age range determined by the CIRB cannot provide assent, an Assent Waiver must be requested from the CIRB and obtained prior to enrollment of the child.
- Question 20: Study participants need a pathway to provide feedback about their experience and express concerns. Describe the pathway the PI provides to study participants and how answers to feedback and concerns are provided based on the questions listed.
COMPLETE THE MEASURES TO PROTECT CONFIDENTIALITY QUESTION
- Question 21: Select all measures used by the PI and research team to protect the confidentiality of study participants.
COMPLETE THE MEASURES TO PROTECT PRIVACY QUESTION
- Question 22: Select all measures used by the PI and research team to protect the privacy of study participants.
COMPLETE THE EMERGENCY RESOURCE QUESTION
- Question 23: Select all resources available to the PI and research team to treat any emergencies resulting from study-related procedures.
COMPLETE THE USE OF LEGALLY AUTHORIZED REPRESENTATIVE (LAR) QUESTIONS
- Question 24: If Question 17 indicates that a LAR could provide consent, select “Yes” for this question.
NOTE: If a LAR is not selected for Question 17 and this question is answered “No,” a study participant cannot be enrolled on a study until this Worksheet is updated to revise these questions and approved by the CIRB.
- Question 25: Select who may serve as a LAR and attach the appropriate Standard Operating Procedures (SOPs).
COMPLETE VULNERABLE POPULATIONS QUESTIONS
- Question 26: The CIRB needs to know whether there are vulnerable populations that could be enrolled into studies and any associated protections. Select the safeguards that the PI and research team may use for each vulnerable population or select “not enrolled” if that population will never be enrolled for that PI.
COMPLETE ADDITIONAL CONFIRMATIONS WHEN INVESTIGATORS ENROLL PREGNANT WOMEN OR WOMEN WHO MAY BECOME PREGNANT ON STUDY
- Question 27: Relates to additional confirmations that need to be made when a PI intends to enroll pregnant women in a study or women who may become pregnant on study.
NOTE: Even though it is unlikely that the PI will enroll a pregnant woman, there are certain confirmations that PIs must make if a participant becomes pregnant. In this case, all three parts of question 27 must be answered “Yes.”
Check selection of “Yes,” to confirm that no inducements will be made to terminate a pregnancy.
Check selection of “Yes,” to confirm that the research team will have no part in decisions related to the timing, method, or procedures used to terminate the pregnancy. Check selection of “Yes,” to confirm that the research team will have no part in determining the viability of a neonate.