Johns Hopkins Bloomberg School of Public Health Committee on Human Research Office for Research Subjects Brown Bag Series A HANDS-ON WORKSHOP: How to Write

Johns Hopkins Bloomberg School of Public HealthCommittee on Human Research

Office for Research Subjects

Brown Bag SeriesA HANDS-ON WORKSHOP:

How to Write a Research Plan

April 19, 2006


• The purpose of the research plan is to describe what, why and how of the research proposal


• A research plan should answer the following questions:– What do you intend to do?– Why should it be done?– How will the research be accomplished?

Who? What? When? Where? Why?

Office for Research Subjects• Areas to address:

– Research Question– Rationale– Methods– Population– Procedures– Risk/Benefits– Compensation– Disclosure/Consent Process– Safety Monitoring (if applicable)– Confidentiality Assurances– Collaborative Agreements/Other IRB approvals


Research Question:

– Pose as a question– Not limited to one question

Does a mental health intervention integrated into an existing employment and training program improve the mental health of program participants?


• Rationale:

• Problem – Briefly describe relevant information that supports the research question

• Background – Provide a summary of related research

• Aim – Describe the importance of the proposed work


• RationaleProblem

It is estimated that almost 21% of children in the United States ages 9-17 had a diagnosable mental disorder associated with anxiety and mood disorders


• RationaleBackground

Twenty-two percent of adolescents ages 16-19 in the East Baltimore neighborhood surrounding Johns Hopkins University have left school are not attached to the labor force (Maryland Department of Planning, 2005)


• RationaleAim

1.To conduct an observational study that examines accessibility and quality of existing mental health services

2.To develop, pilot test, and refine a

community based case management

intervention to monitor adolescent mental

illness


• Methods:Study design and rationale - provide an overview of the study design with a description of the methods to be employed to accomplish the specific aims


• Methods

This study is a placebo-controlled, double-blind dose escalation study in normal healthy adult volunteers recruited from the Baltimore/Washington area. Volunteers will be recruited and screened. A placebo arm is included in the study as a control to better assess vaccine-associated versus non-vaccine associated adverse events. Those volunteers determined to be eligible based on the inclusion and exclusion criteria found in section 5.0 of this research plan will be enrolled


• Population:– Sample size – Indicate the size of the participant

sample needed to address your research question– Power Calculations – If applicable, provide a

statistical power analysis or justify your sample size– Inclusion/Exclusion criteria – Provide detailed

description of the inclusion and exclusion criteria used to determine eligibility

– Gender, Age and Locale – describe gender, age and location criteria for all study procedures


• PopulationSample size

We will recruit approximately 16 adolescents per month. We will recruit up to 160 adolescents; 96 who enroll in the program up to six months after study initiation and 64 who enrolled in the four months prior the study initiation.


• PopulationPower calculations (if not applicable)

Because this is a cross-sectional study to assess the prevalence of mental health concerns, power calculations are not applicable


• PopulationInclusion/Exclusion Criteria Adult males and non-pregnant females between 18 and 50 years of age who are in good general health as determined by means of screening procedures and availability for the duration of the study (26 weeks).Basic ineligibility criteria include: a clinically significant illness, a requirements to take a daily medication, pregnancy, or other condition that in the opinion of the Investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.


• PopulationGender, Age and Locale

Gender: Healthy male and non-pregnant females

Age: 18 to 50 years old

Location of the study: Center for Immunization

Research, Baltimore, Maryland

Office for Research Subjects• Procedures

– Recruitment process – How, where and when will subjects be recruited for participation

– Study Procedures (in sequential order) – describe all study procedures in sequential order

– Methods of Intervention – Describe any applicable plans for intervention

– Methods for Dealing with Adverse Events – how will adverse events be monitored and reported to IRB

– Methods for Dealing with Illegal Reportable Activities - if you are asking about these types of activities, indicate who you will report it to and how you will inform the participant

– Samples Stored Beyond the End of the Study – If applicable, indicate the types of samples to be stored and whether the storage of samples is a condition of study participation or the subject can opt-out


• ProceduresRecruitment Process A list of eligible children from immunization records will be sent local county/town health clinics. These organizations will hand-deliver invitations for participation to the households with eligible children. In the invitation, parents are invited to participate by attending a meeting at their local health clinic at a prearranged date and time. There, the consent form will be reviewed and signed by those agreeing to enroll, and the screener will be completed.


• ProceduresMethods for dealing with adverse events

We do not anticipate any adverse events given the nature of the study. Should any participant contact the study investigators with concerns about their mental health, the study investigators will refer participants mental health specialists with confidential and timely procedures


• ProceduresMethods for Dealing with Illegal Reportable Activities

State law requires that we report sexually transmitted diseases, evidence of child abuse if we find it, as well as information that a volunteer plans to harm themselves or others. We will report this information to the appropriate authorities and we inform the volunteer of this in the consent form.

Office for Research Subjects• Procedures

Samples Stored Beyond the End of the StudyAll specimens will be stored with a unique study number. Samples will be stored in a Dr. X’s lab in the Johns Hopkins Department of Pathology under the supervision of Dr. Y. Electronic data associated with these specimens will be kept on password-protected databases in personal computers and/or servers located at the Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins School of Medicine. Access to the samples and the database is restricted to the PI and study staff designated by the PI.


• Risk/Benefits– Description of Risks – describe risks associated with study

(social and physical)– Description of Measures to Minimize Risks – what will be done

to minimize the magnitude and prospect of risks– Description of Potential Benefits – a description of how subjects

may benefit from participation as well as the significance and likelihood of benefit to others (societal benefits)

– Description of Level of Research Burden – how long will the study take and how might it affect the participants day-to-day activities, including inconvenience


• Risk/BenefitsDescription of Risks

Risks to volunteers are associated with venipuncture, skin biopsy, and with immunization. These risks are outlined below. Female participants will be cautioned of the unknown risks of the study vaccines to the fetus and will be advised to use effective birth control methods for the duration of the study.


• Risks/BenefitsDescription of Measures to Minimize Risks

Volunteers will be vaccinated in a step-wise manner and stopping criteria have been delineated in the protocol. In this way, we hope to minimize the risks associated with the study. Risks and adverse events will also be reported and monitored by a Medical Monitor and a DSMB.


• Risk/BenefitsDescription of Potential Benefits

Volunteers will not receive any direct benefit from participation in this study. It is hoped that information gained in this study will contribute to the development of a safe and effective vaccine.


• Risk/BenefitsDescription of Level of Research Burden

Volunteers will be required to come to the clinic for 14 visits (including screening). Blood will be drawn at each visit (a total of approximately 500ml over a 6 month period) and each visit will last approximately 30 minutes.


• Compensation– Type of Compensation – cash, gift card, debit

card?– Amount of Compensation – describe amount

and breakdown into amount received for each visit and total amount at completion of study

– Schedule of Compensation – when will compensation be provided – at the end of each visit or at completion of study – or both?


• CompensationType of Compensation

Study participants will be given a MasterCard debit card for participating in the baseline study and another card if they participate in the follow-up study


• CompensationAmount of Compensation

Participants will be given a $20 Master Card debit card at completion of the baseline study and another $20 debit card at the completion of the follow-up study.


• CompensationSchedule of Compensation

Compensation will be provided at the end of each study visit. Debit cards will be sent to participants’ home address via US mail after each visit.


• Disclosure/Consent Process– Description of consent process – describe how

consent will be obtained – written, oral, via phone, mail? How will understanding be assessed?

– Who will obtain consent – study staff, principal investigator? Are they qualified to obtain consent – are they aware of regulatory requirements, Good Clinical Practices (GCP)

– Where and when will consent be obtained – participants home, clinicians office, school?

Office for Research Subjects• Disclosure/Consent Process

Description of consent processInformed consent will be obtained prior to enrollment in the study. Volunteers will be allowed as much time as they need to review the consent document and will be encouraged to ask any questions they have regarding the study. Volunteers will be given a comprehension examination regarding the consent prior to their signing the consent document. The volunteer must pass the questionnaire prior to being eligible for enrollment. Study staff will review incorrect answers with the volunteer. The volunteer may either sign the consent at the screening visit, or return after further consideration


• Disclosure/Consent ProcessWho will obtain consent

Consent will be obtained by study staff designated by the PI. In obtaining and documenting informed consent, the Investigator and study staff will comply with the applicable regulatory requirements, current Good Clinical Practice (GCP) guidelines, and ethical principles.


• Disclosure/Consent ProcessWhere and when will consent be obtained

Consent will be obtained at the Center for Immunization Research

OR

Youth consent will be obtained at the school program office. Parental permission will be signed at home and returned to school case advocates via US Mail.


• Safety Monitoring– Who will perform safety monitoring, their affiliation

and expertise– Safety endpoints (AEs or SAEs) to be monitored– Frequency of review by the safety monitor or DSMB

of aggregate summaries or expected AEs or SAEs, and

– The plan for reporting to CHR expected AEs or SAEs that occur more frequently or are more severe than described in the risk section of the research plan or consent form


• Safety Monitoring (for DSMBs)– DSMB Membership, clearly specifying voting

and non-voting members, their affiliation and expertise;

– DSMB Meeting schedule, including a provision for emergency meetings, if required;

– Timing of any proposed interim analysis;– Stopping rules; and– Plans for promptly reporting all DSMB reports

to the CHR


• Confidentiality Assurances:– Certificate of Confidentiality (if applicable)– Data Security– Plans for Record Keeping– Person Responsible & Telephone Number– Plans for Disposition of Identifiers at End of

Study– Where Data will be stored – Who will have access to data


• Confidentiality AssurancesCertificate of Confidentiality

Since this is a small pilot study we will not be applying for a certificate of confidentiality orWe have obtained a Certificate of Confidentiality from the National Institutes of Health – National Institute on Drug Abuse. This information is included in the consent form.


• Confidentiality AssurancesData Security

All study related documents will be kept in locked cabinets in locked rooms with limited access. Information in the electronic database is password-protected and access is available only to authorized research team members. Additionally, each authorized research team member is assigned a level of security clearance (also password-protected) with mandatory password changes every 90 days) for the purpose of limiting access to certain areas or functions of the database. Any information printed from this database is stored in locked files until its use is complete and then shredded.


• Confidentiality AssurancesPlans for Record Keeping

Complete source documentation (study visits, laboratory reports, etc) is kept for each volunteer in his/her individual study chart. All laboratory specimens, reports, study data collection, and administrative forms will be identified by coded number only to maintain participant confidentiality. Case Report Forms using coded identifiers will be used to record data for subjects enrolled in the study. Forms, lists, logbooks, appointment books, and any other listings that link participant ID numbers to other identifying information will be stored in a separate, locked file in an area with limited access.


• Confidentiality AssurancesPlans for Disposition of Identifiers at End of StudyTrial-related documents will be maintained by the Investigator for a period of 2 years after final marketing approval of the vaccine, or if 2 years have elapsed since the formal discontinuation of clinical development of the product. The Sponsor is required to inform the Investigator as to when such documents need no longer be retained. After we receive this notification, all study related documents will be shredded.


• Confidentiality AssurancesWhere Data will be stored

All data will be stored in locked file cabinets and password protected computers. Only study personnel will have access to the data.

Office for Research Subjects• Confidentiality Assurances

Who will have access to dataOnly research personnel involved with this study willhave access to the data. The Investigator, MedicalMonitor, and clinical staff will have access to all clinicaland laboratory data. In addition, study monitors sent bythe Sponsor to ensure compliance of the study withGood Clinical Practices will also have access tovolunteers’ records. The Sponsor, members of theDSMB, and the FDA will receive a summary of thesafety and immunogenicity data (as coded data only).


• Collaborative Agreements/Other IRB Approvals– Description of the Collaboration– Indicate whether letters of collaboration/Local

IRB approvals are pending or have been included for review

– Provide name of Institution – if the collaborating institution is engaged in the research, provide their FWA number

– Describe roles


• TIPS Describe the proposed research in sufficient

detail to eliminate questions from the committee. Do not assume that reviewers know how you intend to proceed

A concise, focused research plan of 3-5 pages is preferable to one made longer be overly elaborate or unimportant details

A projected sequence or timetable is helpful if several methods or procedures will be used


• Instructions– Font size of 11-point type – Presented in consecutive order– Bold headings (all points within heading must

be addressed , even if the answer is N/A)– Each page must include the date and study

title and all pages should be numbered


Questions?

Stephanie Gaudreau


[email protected]

http://www.jhsph.edu/chr

410-614-0346

mailto:[email protected]

http://www.jhsph.edu/chr

Documents

Johns Hopkins Bloomberg School of Public Health Committee on Human Research Office for Research Subjects Brown Bag Series A HANDS-ON WORKSHOP: How to Write