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Homewood Institutional Review Board (HIRB)

The Research Protocol

The main body of the HIRB Application for Exemption and HIRB Application for Expedited/Full

Board Review consists of the research protocol. The items below appear in the Application for

Expedited/Full Board Review, and most of them also appear in the Application for Exemption.

Some of the information in the research protocol will also appear in the informed consent

documents (unless there is an application for a waiver of informed consent). The information

provided in the protocol and consent forms should be consistent.

Principal Investigator. If the PI’s primary association is with the Homewood Schools, she or he

must be a JHU faculty or senior staff member, and this individual must sign the application. If the

PI is outside the Homewood Schools and individuals employed by the Homewood Schools are

engaged in the research (see Sections 4.2 & 4.3), those individuals must submit the application and  note that the PI is outside Homewood.

Student Investigator/Co-Investigator. If the study is an independent student research project

(e.g., independent study project, honors thesis, graduate thesis, or dissertation study), the student should provide contact information and sign the document along with the PI. Student investigators cannot be the PI; a JHU faculty or senior staff member must be the PI and supervise the research. If the study is not an independent student research project and there is a co-investigator, the information for the co-investigator should be provided and she or he should co-sign the document.  Information for additional investigators should be provided in attached Research Team Member forms.

Additional Research Team Members. Report each additional research team member by attaching a Research Team Member form. Research team members include anyone — whether employed by JHU or not — who (a) interacts with research participants (e.g., in recruiting, obtaining informed consent, collecting data, or debriefing), (b) prepares materials for use with participants (e.g., letters to potential participants, interview protocols), or (c) has access to participants’ identifiable data.

Study Title. Use the same study title in all documents submitted to HIRB. PIs can later change the title if they first submit an Application for Amendments and Changes and obtain HIRB approval.

Study Sites. Note all locations where data will be collected and/or analyzed. For each non-JHU site, provide the name of the site, its address, and the name and phone number of a contact person associated with that site. At a minimum, evidence of permission to conduct research at non-JHU sites must be provided. If the sites are engaged in research (see Section 4.2), proof of IRB approval must be submitted or other suitable arrangements must be made before HIRB grants final approval of the research.

Funding Status. Note any funding applications or awards. Attach all grant proposals and funding applications that have been submitted for which funding has been obtained or a score in the fundable range has been awarded. Investigators can also apply for funding following HIRB’s initial approval. They should file an Application for Amendments and Changes notifying HIRB of any funded grant and contract proposals.

Purpose of the Study. Clearly and simply state why the study is being conducted (i.e., goals of the study) and the expected findings (i.e., hypotheses).

Design & Methodology. Clearly describe the study’s design and methodology in terms that

someone not familiar with the design or methodology can understand.

Procedures & Activities. In detail, describe the study’s procedures and all activities participants will be asked to perform. Attach all surveys; interview questions, guidelines, or protocols; and other relevant study materials.

Expedited Review Category. If applicable, specify the expedited review category or categories in which research fits.

Data Access. If the study makes use of materials (e.g., data, documents, records, or specimens) that were or will be collected for nonresearch purposes (e.g., medical diagnoses, employment records), describe how authorization for access to these materials has been or will be obtained.

Participants. Provide the number, sex, race/ethnicity, and age range of the targeted participant

group(s) to be included in the sample. Describe the characteristics of the larger population(s) from which participants will be recruited. Explain how the population(s) are appropriate for the purpose of the research.

Special Categories of Participants. Note any special categories of participants. If children are to be included in the study, complete and attach the Child Checklist and the Assent Checklist along with the assent form or assent script, if appropriate. HIRB regards the special categories of participants listed in the application and others (e.g., economically disadvantaged people, terminally ill individuals) as vulnerable and likely in need of special safeguards. Investigators should describe their safeguards and the rationale for them in the Minimization of Risks section of the protocol.

Inclusion Criteria. Specify the criteria participants must meet to be included in the study and

justify these criteria on scientific and ethical grounds.

Exclusion Criteria. Specify the criteria that will be used to exclude individuals from the study and justify these criteria on scientific and ethical grounds.

Participant Recruitment. Describe how potential participants will be identified and invited to join

the study. Explain how the recruitment methods will yield the targeted sample. Attach all

recruitment materials (e.g., advertisements, e-mail messages, bulletin board notices, phone scripts).

Compensation. Outline the amount, schedule, and procedures for any payments. If payments will be prorated, explain how this will be done. Stipulate any bonuses for completion. Specify any other incentives (i.e., in-kind compensation) and the schedule and procedures for their allocation. If relevant, include the provision of free medical care, such as medical tests, as an incentive.

Risks. Describe all risks that the research reasonably poses to participants. Be sure to consider

physical, psychological, and social (including economic) risks. If the study poses no risks to potential participants, state this.

Minimization of Risks. Explain the procedures for minimizing any risks to participants, including any additional safeguards for vulnerable participants. Include procedures for protecting the anonymity of participants and the confidentiality of data.

Benefits. Describe potential direct benefits to participants and/or benefits to specific others or

society in general. Be realistic. Payments and other incentives are not benefits and should be listed under compensation.

Informed Consent. Provide the required information and attach the requisite consent documents.

Supporting Documents and Checklists

Supporting documents and checklists that may be required for new research applications are located on the HIRB Web site []. Those most frequently required are:

Assent Checklist — Must be submitted with all applications for nonexempt new research

involving children.

Assent Template — Can be used for oral or written assent of children.

Certificate of Translation — For translated consent documents.

Child Checklist — Must be submitted with all applications for nonexempt new research.

Informed Consent Documentation Waiver — For waiver of informed consent


Informed Consent Requirements Waiver/Alteration — For waiver or alteration of the

informed consent process.

Informed Consent Template — For adults. Oral scripts can be based on this document.

Parental Permission Template — Can be modified and used simultaneously for assent of

older children.

Research Team Member Form — For all research team members not listed directly in the

application for new research.

Short Informed Consent Template — Typically for illiterate individuals. A summary

document must accompany this form.

Schedule of Review

HIRB usually meets the first Tuesday of every month. Most applications are reviewed within two to six weeks after HIRB receives a complete application.

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