HHPR Research Guidelines

Student & Faculty Research Guidelines

Students and faculty are encouraged to actively participate in research conducted within the Department of HHPR and/or in collaboration with researchers at various institutions. However, there are a number of university and federal guidelines that dictate how to conduct research particularly when dealing with human subjects that must be adhered to in order to ensure the safe and appropriate protection of human subjects. The following represents the Department of HHPR guidelines for conducting research with human subjects. They are designed to ensure the safety of study participants as well as to ensure that students and faculty adhere to well established guidelines for the conduct of research with human subjects.

I. Educational Preparation

Complete the National Institutes for Health (NIH) course on Human Participant Protection Education for Research Teams. Upon successful completion of the course, print out three copies of the certificate. Keep one for your records, provide one copy to the research supervisor (if applicable), and submit one copy to the Chair of the Department of HHPR. Note that all students, faculty, and/or research collaborators (on and off campus) should complete this course (or similar course from their institution's Internal Review Board [IRB]) and submit copies to appropriate personnel in HHPR in order to document that research team members have been trained in the proper procedures in conducting research on human participants.

II. Develop a Proposal

Discuss the research idea or grant proposal with the Department of HHPR Research Coordinator (Dr. Mike Greenwood), a faculty supervisor, and/or colleagues. Develop a thorough and descriptive proposal that includes the following:

• Rationale and literature review

• Subject population proposed to be studied

• Detailed description of methods and procedures to be employed

• Description of all equipment to be used in the study

• The research team proposed to conduct the study

• Anticipated budget

• Proposed research timeline

For students, the proposal may take the form of the first three chapters of their thesis. For faculty, use of a 5-10 page proposal format is suggested unless designated by the grant sponsor. Copies of proposal formats may be obtained in the Chair's office.

III. Obtain Approval to Submit the Proposal as a Thesis or Grant Proposal

Once a proposal has been developed, it should be submitted for comments to all members of the research team. Proposals involving non-invasive and/or invasive assessment of human subjects must include Ronald Wilson, MD, medical director for the Department of HHPR, as part of the research team. Once all team members approve the protocol, the proposal will be ready for review by a student's research committee and/or submission to a potential grant sponsor (with approval of Dr. Lutz). Note that some grant submissions require IRB approval at the time of submission while others do not. Additionally, some grant sponsors request submission of drafts of research proposals prior to finalizing and/or approving funding a study. These factors must be considered when planning and organizing a study.

IV. Organize and Obtain Approval from the Thesis Committee

Students proposing research for a thesis should identify a research advisor and form a research committee as early as possible during the research planning process. The committee should be comprised of at least two graduate faculty professors within the students major within the Department of HHPR and one member from another department at the university and/or adjunct teaching professor. It is also recommended that the student invite interested researchers from the community and/or collaborative universities to participate as a non-voting participant on the thesis committee in order to provide additional expertise if necessary. The student should then formally present their thesis proposal to the committee for approval. Ideally, thesis committee approval should be obtained prior to beginning the study. However, at times theses may include retrospective analysis of data previously collected. Note that no student or faculty member can be involved in collecting any data on human subjects at Baylor University or at another institution without prior approval from Baylor Universities Human Subjects Protection Committee (see below).

V. Prepare IRB Materials

All studies involving use of animal and human subjects must be approved by the Department of HHPR's Human Subject Protection Committee as then by Baylor University's Human Subject committee. Forms for HHPR IRB and University IRB submission are available on the student and faculty form pages of the HHPR web site. Examples of IRB documents may be obtained from Dr. Mike Greenwood. IRB documents must comply with Baylor University's IRB format. Each IRB submission should include the following components:

Part 1: Signature Page (include Expedited Review Form, if applicable)

Part 2: Introduction and Rationale

Part 3: Methodology

• Study Site(s)

• Overview of Experimental Design (include study design and
list of independent and dependent variables)

• Procedures (All Research Methods)

• Instruments/Equipment to Be Used

• Subjects

Recruitment Methods

Selection Criteria (Inclusion/Exclusion Criteria)

Compensation/Incentives

• Potential Risks

• Potential Benefits

• Assessment of Risks

• Confidentiality

• Data Analysis, Presentation, Publication

• Storage and eventual disposal of data

• Statement of Conflict of Interest

Part 4: Informed Consent Form

• Title of Investigation

• Principal Investigator(s)

• Coinvestigator(s)

• Sponsors

• Rationale

• Description of the Study:

• Exclusionary Criteria

• Risks and Benefits

• Alternative Treatments

• Costs and Payments

• New Information

• Confidentiality

• Data Storage and Eventual disposal of data

• Right to Withdrawal

• Compensation for Illness or Injury

• Statement on Conflict of Interest

• Voluntary Consent

Part 5: Checklist for the Informed Consent (includes examples of informed consent, statement of parental consent, and disclaimer for internet use)

Part 6: Research Instrument(s) (such as surveys, interview questions, etc.)

Appendices (other information pertinent to the proposal, such as consent letters already received from participating agencies, etc.)

VI. Submit Materials to the Department IRB Committee

Once the IRB materials have been prepared, they must be submitted to the Department of HHPR IRB committee for review. Please submit these materials no later than one week prior to IRB submission deadline to Dr. Mike Greenwood, Chair, HHPR IRB Committee. The Department IRB committee serves as an initial evaluator of the proposed study. The committee is designed to provide feedback to the student/faculty member regarding any possible problems that may be seen by the University's IRB Committee in reviewing the proposal. Most submissions will require some minor editing and/or changes prior to approval by the Department IRB committee. After the Department IRB committee has approved the protocol, it will be submitted to Dr. Lutz for final review and approval.

* No IRB protocols, including expedited protocols, should be submitted to the University's IRB committee until after it has been approved by the Department IRB Committee and Dr. Lutz.

Policy on Research Collaborators

Each university may differ on the requirement of collaborating researchers to have approval at Baylor or their institution prior to being involved in a research study. Baylor University requires submission of IRB materials for any student and faculty member participating in a study on human subjects whether conducted at Baylor or another institution. This is true regardless of whether a collaborating investigator has IRB approval at their institution. If you list a collaborator on your IRB submitted to Baylor, it is your responsibility to contact the collaborator and have them determine whether their university requires dual submission prior to them becoming involved in the study.

VII. Submit Application to University IRB Committee

After the Department IRB Committee and Chair have approved the protocol, it may be submitted to the Universities IRB Committee. No research involving human subjects can begin until after the University IRB Committee has reviewed the protocol, approved it, and you receive written documentation from the committee that your protocol has been approved. You will receive a form with a seal of approval that must be used on all informed consent statements used by subjects in your study.

VIII. Conduct the Study

Once IRB approval has been obtained from the University Committee, you are now ready to conduct the study.

IX. Notify IRB Committee of Any Change in Protocol

It is not unusual that, no matter how well planned a study may be, minor or major modifications may be needed to be made to the protocol once a study begins. Any change in location, methods, procedures, and/or experimental design of an approved study must be submitted to the University IRB Committee for approval. Making significant changes to an existing IRB is not permitted unless it is performed in order to reduce the immediate risk to the study participant and/or has been approved by the IRB committee. The general rule is that if the change in protocol significantly alters the methods of the study and/or increases the risk to the subject, IRB approval must be obtained before such a change is made unless the change was implemented in order to reduce risk to the subject during the protocol.

X. Report New Findings & Adverse Events

The Principal Investigator is responsible for reporting any new finding and/or significant adverse event associated with a subject's direct involvement in an approved study. New findings are "unexpected problems whose nature, severity, and frequency are not described in the information provided to the IRB or to participants." Examples include unexpected complications in a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events should be reported to the Chair of the Department and IRB within 10 working days. The report of the event should discuss:

• the facts of the case, including the date and a description of the subject;

• whether the event is related to the study's procedures or drugs or to the subject's underlying disease or condition;

• the steps that have been taken to address the problem;

• whether the event is likely to recur; and whether the event provides new information about the study's risks that should be conveyed to participants, in a revised consent form.

The Department's policies on adverse events are based on Food and Drug Administration regulations. According to the FDA, a "serious adverse drug experience" with respect to human clinical experience includes "any experience that suggests a significant hazard, contraindication, side effect, or precaution," including "any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose." An "unexpected adverse experience" is any adverse experience whose nature, severity, and frequency of risk are not described in the information provided for IRB review or in the consent form. (See 21 CFR 312.32 [4-1-92]). See Beth Davis for copies of the ESNL's Adverse Event Documentation Forms.

XI. Analyze Data

After data has been collected, the next step is to analyze data collected. See Chris Rasmussen about efficient ways to enter and organize data for statistical analysis.

XII. Publish Thesis, Abstract, and/or Article

A general principle of research is that "its not research unless it has been published and referenced by other scholars". Therefore, the research process is not done until papers are prepared and published. If you are conducting a thesis, your goal is to prepare the study in thesis format and present it to your committee for approval. Once approved, you should work with your thesis advisor to submit the paper for presentation and publication. If you are a faculty member, your goal is to present the paper at an appropriate professional conference and then publish the results in a reputable journal. Presentation of research findings at national and international meetings as well as publication of original research, insightful reviews, and relevant books are primary ways the Department can distinguish itself among its peers.

Summary

The Department of HHPR encourages students and faculty to conduct high quality funded and non-funded research trials. The Department has significant expertise in conducting human subject's research. However, the approval of conducting research must adhere to appropriate safeguards and guidelines. Adhering to these protocols will help ensure that the research experience within the Department is safe, relevant, and highly productive.