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Investigator-Initiated Research Early Assessment Program

1. General Information

Investigator-initiated research involving interventional treatment on human subjects is a valuable component to the academic and research initiatives of the Drexel University College of Medicine (DrexelMed). This research is unique in that the investigator serves not only as the principal investigator but also the sponsor. Thus, the researcher can expect a higher level of preparation, consideration, and responsibilities. In addition, DrexelMed must also assume a higher level of responsibility and risk as the institution housing such research. Researchers should also expect to meet additional institutional requirements based on the nature of the research.

Substantial time and resources are spent in developing, preparing, and conducting investigator initiated research involving interventional treatment on human subjects. Researchers can expect committing additional time and resources in such research. Researchers often experience delays in starting investigator-initiated research due to unanticipated regulatory and institutional requirements. Below are examples of such additional requirements:

  • Securing an IND
  • Designing protocol and other documentation necessary to memorialize and record research data and events
  • IRB requiring a data safety monitoring board or other additional monitoring
  • Securing facilities, services, equipment
  • Involving additional investigators
  • Obtaining additional staff such as a research nurse or lab personnel
  • Obtaining funding for research costs (i.e. non-standard of care procedures)
  • Obtaining the necessary patents or licenses to conduct research
  • Resolving and/or managing any conflict of interest

Many times researchers only consider these requirements after spending substantial time and resources designing the study and preparing documentation – only to realize later that meeting such requirements would involve redesigning the protocol or obtaining additional resources or funding.

Investigator-Initiated Study Advisory Committee (IISA Committee) and Early Assessment Program

The Investigator-Initiated Study Advisory Committee (IISA Committee) is a group consisting of DrexelMed members from various administrative departments (i.e. Clinical Research Group, Office of Regulatory Research Compliance, Office of General Counsel) . The IISA Committee was established to provide researchers an early assessment of their research to identify additional regulatory and institutional requirements imposed on such research. The early assessment will allow researchers to plan for these additional requirements. In addition, the early assessment will also allow DrexelMed, as the research institution, to conduct a risk and cost analysis. Such early assessment is aimed to reduce the delays in initiating such research.

In order to conduct a thorough assessment, the IISA Committee may involve other DrexelMed members based on the unique characteristics of the study and expertise of members in relation to a proposed study. In order to assess the above considerations, the following members may be involved in the assessment:

  • Vice Dean for Research
  • Office of Technology Commercialization
  • Office of the General Counsel
  • Office of Risk Management
  • Researchers with similar expertise

The IISA Committee pre-review applies to any interventional research involving human subjects where the investigator serves as sponsor for use of a drug, biological or device regardless of whether such research receives external funding. If the following applies, IISA Committee Pre-review is required:

  • Investigator partially or completely developed protocol and
  • Research involves human subjects and
  • Research involves any type of intervention (e.g. use of a drug, device, procedure)
  • Whether or not such research receives external funding (e.g. private foundation or company)

Serving as Sponsor and Investigator

In addition to fulfilling the responsibilities as an investigator, the research must also fulfill responsibilities as the sponsor of the research and meet certain College requirements. This includes:

  • Securing an IND
  • Securing patents and/or licenses to use any drug, device, or other patentable material
  • Developing and drafting the protocol
  • Designing case report forms and other documentation necessary to memorialize and record research data and events
  • Drug Accountability
  • Submitting Safety Reports to the FDA
  • Complying with all applicable FDA regulations

Additional Requirements for Human Subject Protection

The IRB may impose additional requirements based on study design and the risk to human subjects. Such requirements may include a higher level of oversight, shorter reporting time periods, radiation and biosafety committee review. The IRB is an independent review board and the IISA Committee has no authority in restricting the requirements of the IRB. However, the IISA Committee can advise researchers on anticipated requirements that may be imposed by the IRB. This will allow the researcher to develop and prepare the study to meet such potential requirements. In addition, the IISA Committee can also advise the researcher on which IRB the researcher should submit the research for review. This will avoid submitting research to an inappropriate IRB.

Facilities and Services

In order to ensure compliance with the protocol, the researcher must also assess and obtain the appropriate services, equipment, and facilities. The following facilities or equipment may be needed. Even if such facilities or equipment exist, researchers should ensure that access to such facilities and equipment can be obtained.

  • Medical Records (e.g. medical records maintained by DrexelMed, Hahnemann University Hospital, St. Christopher’s Hospital for Children). Researchers are expected to comply with DrexelMed policies and procedures to access to such records.
  • Radiology facilities
  • Clinical Laboratory
  • Specific diagnostic or therapeutics instruments
  • Nursing services

Additional Researchers and Support Personnel

Researchers should consider involving additional investigator(s) and support staff needed to conduct the research. Additional investigators should be considered for the following reasons.
  • Identification of potential study subjects
  • Medical responsibility for study subjects
  • Accurate reporting of data
  • Expertise
  • Amount of investigator time required to conduct the research.

Research support staff may include:

  • Research Coordinators or Clinical Research Nurse Coordinators
  • Laboratory Personnel
  • Data Analysts

Research Coordinators / Clinical Research Nurse Coordinators are usually staffed in order to fulfill the following responsibilities:

  • Preparing IRB documents
  • Subject Recruitment
  • Drug Management (i.e. storage, dispensing, inventory, disposal)
  • Consenting subjects
  • Completion of Case Report Forms
  • Preparing Adverse Event Reports
  • Data collection with detail orientation
  • Day-to-day problem solving
  • Reporting Non-compliance

Conflict of Interest

Due to the nature of IIS research, conflict of interests may arise. The IISA Committee Pre-review will allow for an early assessment of conflict of interest. Thus, the institution will be able to start assessing any conflicts before IRB submission. This will allow the researcher to arrange for additional institutional requirements (e.g. change of facility, change of IRB, additional/removal of researchers, arranging a biosafety/monitoring committee) prior to preparing regulatory and study documentation and prior to IRB submission. Note that such review is restricted to the institution’s assessment and management of the conflict and that the IRB may require additional requirements.

Funding and Cost Analysis

The researcher must ensure funding is available to support the necessary facilities, equipment and staffing necessary to conduct the research. In addition, researchers will be expected to provide the IISA Committee with a research cost analysis. Such analysis should provide the following:

  • Identify additional facilities, equipment and staffing necessary for the research and source of funding
  • Identify treatment procedures (i.e. standard of care) and the payee for such procedure (e.g. DrexelMed, Hahnemann, St. Christopher’s Hospital for Children, Medical Practice)
  • Identify research procedures (e.g. non-standard of care) and the source of funding
  • Identify Subject stipends (if applicable) and the source of funding
  • IRB or regulatory committee fees if the local IRB is unable to review

Researchers are not expected to initially submit this analysis for the IISA Committee since the pre-review may be used as an opportunity to conduct this analysis. However, researchers should provide as much of the above information to expedite the pre-review.

2. Instructions for IISA Committee Pre-Review

The following is a step-by-step instruction on the Pre-Review process.

Step 1: Researcher Submits Pre-Review Questionnaire and Required Information.

The following documentation should be provided:

  1. Copy of the protocol or protocol summary (only if fully developed protocol is not available yet).
  2. Copy of case report forms.
  3. IRB Application Form (Full-Review). In the interest of reducing the efforts and resources in preparing documentation for the IISA Committee Pre-review and avoiding multiple forms requiring the same information, the IISA Committee will utilize this form for the Pre-Review. Each IRB has its own IRB Application form. Note that the IISA Committee may determine that the study should be submitted to an alternative IRB such as WIRB.
    4. Once completed, the researchers should sign the IRB Application form in the designated areas and obtain the signature of any personnel disclosing a conflict of interest. In addition, the researcher should obtain the signature of the Department Chair. No other signatures are required for this Pre-review.
  4. Cost Analysis Form. This form should be signed by the investigator and the Department Chair. In the interest of avoiding any delays and assure an efficient pre-review, researchers should provide any additional information not contained in the above documentation that s/he believes is important in assessing the research.

Step 2: Pre-Review Meeting

After the submission, IISA committee members will review the submission. If necessary, the IISA members may involve other Institution personnel as described above to assess the study and may ask the researcher for additional information. The IISA Committee will then meet with the researcher and review the documentation. The IISA Committee can make the following recommendations:

  1. Recommend that the researcher fulfill any of the responsibilities described above and provide supporting documentation before advancing the study.
  2. Recommend that the researcher submit the study to a particular IRB (e.g. Local IRB, WIRB).
  3. Recommend additional monitoring such as a data safety monitoring board.
  4. Recommend that a researcher (e.g. principal investigator, sub-investigator) eliminate, limit, or expand their responsibilities in the conduct of the research.
  5. Recommend any other action necessary to conduct the research at the Institution.
  6. Recommend that the research not be conducted at the Institution.

Step 3: Institution Determination

The IISA Committee recommendations will then be submitted to the Vice Dean for Research. The Vice Dean for Research will make a final determination on any Institution requirements. Researchers should realize that the Institution and the IRB are independent bodies and both have authority to require actions be taken prior to initiating the study.

In the event both bodies require similar action, the stricter action should be followed.

Researchers will be notified of the Institution’s determination and shall take any required action before submitting the study to the designated IRB. Researchers are required to follow all Institutional guidelines in implementing approved protocols.

3. Forms