Study Title:
Principal Investigator:
Version Date:
LOCAL IMPLEMENTATION PLAN (LIP)
PART I
*Fill in header information.
Instructions:
· This form is required for new study submissions; it should be submitted with the Institutional Review Board (IRB) – Institute of Translational Health Sciences (ITHS) Application and any relevant Supplements.
· Answering the questions posed in this form, provide a summary of your Local Implementation Plan (LIP). The purpose of this document is to provide a summary of how your study will be implemented at Seattle Children’s.
· The LIP is considered a “living” document that should be updated and submitted to the IRB with each modification or renewal that involves change to the LIP.
Note: There are two (2) Parts to this form
· Part I must always be completed.
· Part II must be completed if there is no protocol provided. If a protocol is attached, then Part II may be skipped.
· Please note that protocol templates have been developed for optional use. These are available on the IRB Web site.
1. Summary of the Research (1 to 1 ½ pages or less)
1.1. Concise Description
Using lay language, please provide a concise summary outlining the purpose of the research, the rationale for this study and the general study design (how the aims of the study will be accomplished). The description should be detailed enough to allow someone who is not an expert in the field to understand the context of the research question(s) being asked.
Investigator Help: Why does the IRB request that I use lay language for this information? The IRB primarily asks this because by regulatory requirement the IRB must contain non-scientific members as well as members who are not affiliated with Seattle Children’s (i.e., community members). To facilitate the review of this study for such members, lay language should be used rather than the more scientific language found in protocols, etc.
2. Local Study Population
Investigator Help: State the total number of participants expected to enroll in relation to the number anticipated for screening (e.g. 100 participants will be screened / evaluated to randomize a total of 50 participants; if you will enroll all participants you screen or approach, the same number should be placed in both boxes). For multi-site studies, enter the number of participants to be screened and enrolled at Seattle Children’s, as well as the number of participants to be screened and enrolled at all Non-Children’s site(s) in the appropriate boxes. If this is not a multi-site study, then please place “N/A” in the boxes for Non-Children’s Sites.
2.1 Approximate Number and Ages of Study Population
Participant Group / Age at Enrollment*Children’s / Non-Children’s Sites
Screen / Enroll / Screen / Enroll / Entire Study
Healthy Participants/Controls
Patients/Cases
Other (specify, e.g., parents, other family members, school teachers)
*If participants will be greater than age 21 (not including parents participating with their children), institutional sign-off will be required.
Seattle Children’s Policy: More information on this policy can be found at http://child.childrens.sea.kids/Documents/Policies_and_Procedures/Administrative/10796.pdf
3. Recruitment: Screening and Approach of Local Study Population
Screening and Approach
Investigator Help:
In-person initial contact: When the researchers are not known to the research participants, the recruitment methods must take steps to protect the privacy and confidentiality of participants. So, when researchers propose to directly contact individual participants in person, by telephone or by letter or email, the approach to recruit must be done by an individual known to the participant or their legally authorized representatives or by an individual who would have access to the participant and their representatives by virtue of providing routine care and services.
Sample answer for screening: All potential participants are either existing Seattle Children’s patients who have relapsed or are patients that are referred here by their treating physician. Once a patient has relapsed or has been referred to Seattle Children’s, the Hematology/Oncology (Hem/Onc) treating physician will identify potential treatment options for the patient including open phase 1 studies. If there are any appropriate phase 1 studies, the physician will inform the Research Nurses and appropriate Clinical Research Associate that a patient may potentially be interested in participating in the study. The research nurses and clinical research associate will then review the patient’s medical records to help review and identify study specific eligibility requirements that will need to be verified if the patient chooses to enroll into the phase 1 study.
Advertisements: Please ensure that any recruitment ads inform participants of the following (for more information and templates):
A. The participant is being asked to take part in research.
B. The basic purpose of the research study.
C. The basic eligibility criteria for research participants.
D. A brief description of the project (e.g., whether it involves a blood draw, use of an investigational drug, or an interview).
E. The length of expected participation for individual participants.
F. Compensation, payment or incentive participants will receive.
G. Contact information to obtain more information about the research project such as the name and telephone number of the research study coordinator or the name and contact information for the Principal Investigator (PI). In some cases the research coordinator or PI may wish not to be named in the advertisement. In such cases, a title (e.g., research coordinator) will suffice.
H. The Department/Division of the PI and the PI’s institutional affiliation (e.g., Seattle Children’s; University of Washington). The Seattle Children’s logo should be used on all recruitment advertisements, and must adhere to the hospital graphic identity standards (typestyle and graphics). Questions about using the Children’s logo should be referred to Seattle Children’s Marketing & Communications Department.
Letters: When potential participants are recruited from Seattle Children’s via a letter to the participant or their legal representative (e.g., parent(s) of the child), the recruitment letter in addition to the elements described above for advertisements, should:
A. Be signed by a person who has clinical access to the participant’s/parent’s name, address and confidential information about the potential participant’s diagnosis or care. (If you are not recruiting from Seattle Children’s patient population, the letter should be signed by someone who is known to the participants, if possible.)
B. The letter should be written on Seattle Children’s letterhead if the patient is to be approached by a representative of the hospital. If another agency will make the approach, then it may be appropriate that letterhead from that organization be used instead.
C. Instructions for the participant/parent on what will happen if they do not respond to the letter (e.g., receive a follow-up telephone call in two weeks). In many cases, the IRB will require researchers to provide a return envelope with a form that families can indicate if they are interested in hearing more about the research and the best way and time to contact them as well as their contact information, or if they are not interested and to request no further contact. Return postcards should not be used as they do not allow participants to provide information to researchers in a manner that will guarantee their privacy.
D. Note: To protect the privacy of participants and families, the envelopes in which recruitment letters are sent, should not contain any specific department, program or center names (even if the actual letter should). This pertains to the outside, including front and back, of the envelope or mailer. No information should be used that could identify a patient’s condition, such as a department logo, type of current or past conditions, treatment procedures or tests, or any other similar information.
Telephone calls: In most cases, the IRB does not approve direct telephone calls as the first method to recruit participants. The IRB recommends that the first methods for recruitment utilize in person approaches, recruitment letters, or advertising. The IRB does allow follow-up telephone calls as a second method of recruitment after participants have been initially approached to take part in the research either in person or by letter. In general, the IRB allows no more than 2 follow-up telephone calls (a voice message on the answering machine or speaking directly to the potential participant or their legal representative).
Seattle Children’s Policy: The IRB will consider the following criteria from IRB Policy-024: Recruiting Potential Research Participants when evaluating your proposed recruitment methods.
3.1. Indicate how local team will advertise for/identify potential participants for approach (e.g., medical records, other studies, etc.). Please check all that apply & provide with application:
Web site Other studies
Flyer(s) Advertisement(s)
In person through clinic Medical records/Clinic schedules
Existing databases Other (please explain):
3.2. Once identified as possible participants, describe how individuals will be approached about the research (check all that apply):
In person (e.g., during clinic visit/hospital stay)
By letter
By telephone – investigator initiated (e.g., investigator makes first contact)
By telephone – participant initiated (e.g., potential participant makes first contact)
Other (please explain):
3.3. Describe who will approach potential participants about the research.
3.4. Describe where (e.g., sites, clinics, units, etc.) potential participants will be approached about the research.
3.5. If you are recruiting/approaching potential participants from more than one site/location, do your recruitment/approach strategies differ at each site/location?
Yes à Describe your recruitment practices at each site/location.
No
N/A
3.6. Describe when (the timing of) potential participants will be approached about the research.
3.7. Are recruitment/approach materials attached to the application (e.g., flyers, advertisements, approach letters, telephone script, etc.)?
Yes à Please list.
No à Please explain why.
Investigator Help:
Protections for Privacy and the Minimization of Possibility of Coercion and Undue Influence: The screening and approach of research participants must include regulatory protections afforded participants, including but not limited to privacy and minimization of the possibility of coercion and undue influence. The below questions ask you to describe the screening and approach of research participants for your study in light of this.
Seattle Children’s Policy: See IRB Policy-024: Recruiting Potential Research Participants for additional guidance regarding approach.
3.8. How will the approach protect the privacy of research participants and their families?
Use of a private room to discuss potential participation.
Use of an intermediary known to potential participant if s/he does not know researcher (usually required).
Other (please explain):
3.9. What steps will be taken to avoid coercion or undue influence in the approach/recruitment process? Please check all that apply:
Sufficient time will be allowed to consider participation. Please describe amount of time allowed and rationale.
Investigator Help: Examples of situations where timing considerations for direct approaches need to be considered include approaches to newly diagnosed patients, patients diagnosed with a terminal illness, patients in emergency or critical care situations, family members of a recently deceased patient, and patients scheduled for same day surgery.
Sample answer: Participants are never asked to consent on the same day they are approached. Families are encouraged to take as much time as they need to reach a decision. However, Children’s Oncology Group (COG) will reserve a spot on this study for only 7 days and some eligibility screening may be required so families are required to reach decisions fairly quickly. It is possible that families know about this study prior to spots opening, but that is not always the case.
No individual in a position of authority/influence (e.g., treating physician) will approach potential participants for participation in the study.
Individual(s) in a position of authority/influence (e.g., treating physician) will approach potential participants but there will be steps taken to avoid coercion/undue influence. Please describe those steps and rationale.
Emphasis on concept that deciding not to participate will not impact patient’s care.
Other (please explain).
4. Study Incentives
Investigator Help: (Relevant definitions):
Reimbursement is a form of payment to research participants that is intended to pay for actual, out-of-pocket expenses directly related to taking part in a research activity. Typical out-of pocket expenses are transportation, food, childcare, lodging, and transportation. These out-of-pocket expenses must be supported by documentation – usually an original, itemized receipt. Reimbursing for mileage is allowable while reimbursing for gas is not. Reimbursement payments are ONLY made by check.
Incentive (also known as inducement or compensation) is a form of payment to research participants that is typically intended to pay generally for a participant’s time and effort, as a general thank you for taking part in research. These forms of payment are considered income to the research participant by the Internal Revenue Service (IRS).
Seattle Children’s Policy: For more information, refer to the Office of Research Finance Policy-004: Research Participant Payment Tracking as well as IRB Policy-036: Payments to Take Part in Research.
4.1 Will research participants receive an incentive to take part in the research activity (e.g., gifts, payments, services without charge)?
Yes à Answer the following questions 4.2 – 4.5.
No à Skip to section 4.5.
4.2 Describe the incentive and the reason for this incentive.
Investigator Help:
Sample answer: Participants who agree to optional pharmacokinetic (PK) and correlative studies blood draws will receive a monetary incentive of $25 via check or gift card to acknowledge the extra time commitment and discomfort involved.
4.3 Describe who will receive the incentive payment (child, parent, etc.).
4.4 Describe the amount, method (check or gift cards), and timing (schedule) of the incentive payments.
Investigator Help:
Sample answer: Participants will receive $50 for their participation in serial Pharmacokinetics on day 1 and $25 for their return visits on day 2 to acknowledge the extra time commitment, for a maximum incentive of $75. Participants need not complete all serial draws on day 1 to receive the $50 payment for that day. The preferred method of payment will be via check to maximize flexibility for the recipients and for tracking purposes. The identifying information that will be collected solely for payment purposes (name, address, Social Security Number) will be kept separate from research data and will not be retained for research purposes. This information will be sent directly to the Finance Department as soon as possible and all copies of it will be destroyed upon confirmation that the Finance Department has received the information needed/participants have received their payment. If a participant refuses to provide any of the required information for payment purposes (e.g., Social Security Number), then there will be two options for them: 1) forego the research payment; or 2) a gift card for a local store will be offered instead, with the understanding that the research team needs to submit a written explanation of the situation to Research Finance in accordance with Office of Research Finance Policy-004: Research Participant Payment Tracking.