Johns Hopkins Bloomberg School of Public Health

1
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 a Research Plan
• April 19, 2006

2
Office for Research Subjects

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

3
Office for Research Subjects

• 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?

4
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

5
Office for Research Subjects

• 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?

6
Office for Research Subjects

• 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

7
Office for Research Subjects

• Rationale
• Problem
• 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

8
Office for Research Subjects

• Rationale
• Background
• 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)

9
Office for Research Subjects

• Rationale
• Aim
• 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

10
Office for Research Subjects

• 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

11
Office for Research Subjects

• 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

12
Office for Research Subjects

• 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

13
Office for Research Subjects

• Population
• Sample 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.

14
Office for Research Subjects

• Population
• Power calculations (if not applicable)
• Because this is a cross-sectional study to
  assess the prevalence of mental health concerns,
  power calculations are not applicable

15
Office for Research Subjects

• Population
• Inclusion/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.

16
Office for Research Subjects

• Population
• Gender, 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

17
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

18
Office for Research Subjects

• Procedures
• Recruitment 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.

19
Office for Research Subjects

• Procedures
• Methods 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

20
Office for Research Subjects

• Procedures
• Methods 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.

21
Office for Research Subjects

• Procedures
• Samples Stored Beyond the End of the Study
• All specimens will be stored with a unique study
  number. Samples will be stored in a Dr. Xs 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.

22
Office for Research Subjects

• 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

23
Office for Research Subjects

• Risk/Benefits
• Description 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.

24
Office for Research Subjects

• Risks/Benefits
• Description 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.

25
Office for Research Subjects

• Risk/Benefits
• Description 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.

26
Office for Research Subjects

• Risk/Benefits
• Description 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.

27
Office for Research Subjects

• 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?

28
Office for Research Subjects

• Compensation
• Type 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

29
Office for Research Subjects

• Compensation
• Amount 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.

30
Office for Research Subjects

• Compensation
• Schedule 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.

31
Office for Research Subjects

• 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?

32
Office for Research Subjects

• Disclosure/Consent Process
• Description of consent process
• Informed 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

33
Office for Research Subjects

• Disclosure/Consent Process
• Who 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.

34
Office for Research Subjects

• Disclosure/Consent Process
• Where 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.

35
Office for Research Subjects

• 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

36
Office for Research Subjects

• 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

37
Office for Research Subjects

• 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

38
Office for Research Subjects

• Confidentiality Assurances
• Certificate of Confidentiality
• Since this is a small pilot study we will not be
  applying for a certificate of confidentiality
• or
• We 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.

39
Office for Research Subjects

• Confidentiality Assurances
• Data 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.

40
Office for Research Subjects

• Confidentiality Assurances
• Plans 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.

41
Office for Research Subjects

• Confidentiality Assurances
• Plans for Disposition of Identifiers at End of
  Study
• Trial-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.

42
Office for Research Subjects

• Confidentiality Assurances
• Where 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.

43
Office for Research Subjects

• Confidentiality Assurances
• Who will have access to data
• Only research personnel involved with this study
  will
• have access to the data. The Investigator,
  Medical
• Monitor, and clinical staff will have access to
  all clinical
• and laboratory data. In addition, study monitors
  sent by
• the Sponsor to ensure compliance of the study
  with
• Good Clinical Practices will also have access to
• volunteers records. The Sponsor, members of the
• DSMB, and the FDA will receive a summary of the
• safety and immunogenicity data (as coded data
  only).

44
Office for Research Subjects

• 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

45
Office for Research Subjects

• 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

46
Office for Research Subjects

• 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

47
Office for Research Subjects

• Questions?
• Stephanie Gaudreau
• Office for Research Subjects
• sgaudrea_at_jhsph.edu
• http//www.jhsph.edu/chr
• 410-614-0346