Research Affairs / 
Human Studies Life Cycle: Get Started


Develop the Study Idea (for PI-initiated clinical studies)

Activities Preparatory to Research

Determine Feasibility

Prepare the IRB Protocol


Grant Applications

Prepare Recruitment Materials and Informed Consent Documents


Complete Confidential Disclosure Agreement (for industry-sponsored trials)

Plan for IRB Review


Choose the Appropriate IRB Application

Identify Study Personnel

Consider Special Study Requirements

 


Activities Preparatory to Research

 

Reviewing patient records in order to design a research study, or to determine the feasibility of a research study, is considered “preparatory to research” under the Privacy Rule.  See instructions for Preparatory Research in the LLU Investigator's Guide to HIPAA and Data Request Form (see also Data Request Instructions).

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Determine Feasibility

 

Industry-sponsored

PI-Initiated

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Prepare the IRB Protocol

 

To make sure the IRB has adequate information to complete its review expediently, be sure the following questions and topics are addressed in the protocol.  Assure that the content of the protocol is consistent all other materials submitted to the IRB, especially the consent documents.  The IRB frequently asks for corrections of inconsistencies in such areas as number of subjects to be enrolled, number of study groups, or dosages. 

 

Completeness of Presentation

The IRB protocol is different from the information contained in a dissertation or funding proposal.   Provide a summary of the research design, highlighting techniques used, data analysis, and statistical methods (see Protocol Outline).  If lengthy documents such as the Investigator’s Brochure or grant application are involved, they should be provided as an attachment for reference purposes only, as a supplement to, NOT replacement for, the IRB’s required protocol (see Applicant Checklist for Convened IRB Review).

 

Ethical Concerns

As the expert in the field, your insights are helpful.  Be open about your concerns, sharing your methods for preventing or managing ethical dilemmas.  For example, if deception is required, justify the need and describe any possibility for debriefing.  If you anticipate concerns about the social impact of the research or its associated technologies, you are invited to consult the LLU Bioethics Center for counsel.

 

Review for Scientific/Scholarly Validity

In most cases, a statistician should be consulted as part of the initial design of the study to help determine how many subjects should be enrolled.

For biostatistical analysis support, contact the Research Consulting Group or for student projects contact Research Affairs for recommendations.

 

Subject Selection

The design of the study should reflect the ethical principle of justice, fairness in distribution in its selection of potential participants, i.e., who will receive the benefits of research and bear its burdens.  The systematic selection of some classes of individuals simply because of their easy availability, their compromised position, or manipulability, rather than for reasons directly related to the problem being studied must be avoided.

What are your inclusion/exclusion criteria? Don’t forget the obvious, like disease state, contraindicated medications, sex, or age of subject.  Reflect on psychosocial variables that may impact subject risk and study compliance.  Don’t list exclusion criteria that are merely stating the opposite of the inclusion criteria.

Does the selection of subjects demonstrate an awareness of possible use of populations already being studied at LLU? Be alert to the pitfall of selecting a population just because they are easily available: students, patients, school groups, Seventh-day Adventist members (see Special Populations).

 

Subject Recruitment

If advertising is needed for subject recruitment, describe your plan for using media, and provide a copy of any advertising (ads, posters, hand-outs), wording of public service announcements.  If access to subjects is by way of an institutional relationship (i.e., clients or patients of another facility), obtain a letter of cooperation from the “gatekeeper” for that facility.  Note that an amendment may be submitted to request extending recruitment to additional sites after initial IRB approval.

Describe step-by-step how the subject will be approached/solicited, who will do the informing and consenting, the conditions under which the subject will be approached, exactly what they will be told, etc.  Be frank about potential for coercion and present a plan for managing such possibilities. 

 

Subject Incentives/Reimbursement

Describe any plan for offering payment to subjects, specifying what the incentive is (gift certificate, cash, check, gift items).  Financial incentives are often used when benefit to subjects is remote or non-existent, especially if research participation is extensive and time consuming. The amount of remuneration should be reasonable and commensurate with the expected contribution of the subject and should not constitute undue pressure to volunteer for the research project. Amount of remuneration should include consideration of travel and parking expenses, time commitment, etc. 

Just as the size of payment can put inappropriate pressure on subjects, so can the schedule of payment.  Holding payment until the subject has completed every procedure in a long, multi-week, multi-visit study is inappropriate.  For studies with more than two or three visits, payment should be prorated, that is, based on the amount of time subjects have spent participating so far. Any departure from this guideline should be justified to the IRB. 

Remuneration for participation in research must be described in the Consent Form and approved by the IRB. In order to receive such payments, subjects may be asked to provide their home address and/or Social Security number.  If they receive $600 or more from Loma Linda University for taking part in this research study or a combination of studies in one tax year, they will be sent a 1099 form as required by IRS.  Payment to research subjects for participation in studies is not considered a benefit, it is a recruitment incentive.

 

Respect for Confidentiality and Privacy

Describe the setting for each stage of research consenting and subject intervention with regard to physical comfort, privacy, convenience, travel required.  Demonstrate consideration for subject’s ability (mental, physical, developmental), environment, educational level, geographical location, and social context (especially for children and teens, and other vulnerable populations).

 

Deception or Withholding Information from Subjects

There are times, especially in behavioral research, when investigators plan to withhold information about the real purpose of the study or purposely give subjects false information about some aspect of the research. The use of deception or incomplete disclosure imposes special responsibilities on the investigator and the IRB.

The IRB will NOT approve a study that presents more than minimal risk where subjects are deceived or not given complete information that they would consider material to the decision to participate.  However, minor deception, such as withholding specific points of interest in an attempt to prevent a bias in the results, can be acceptable, provided the subject is fully debriefed after participation. Risks stemming from major deception, such as leading a subject to believe that s/he has committed a crime or has a disease, must be clearly counterbalanced by the benefits of the research.

The IRB may require debriefing when it contributes to the subject’s welfare to more fully disclose the purpose of the study, correct painful or stressful mis-perceptions, or reduce pain, stress, or anxiety concerning the subject’s performance.

Investigators should justify, in detail, in the protocol, the reasons for deceiving or withholding information from subjects, including an explanation of: a) the necessity for deceiving subjects; b) how the potential benefits of the research justify the use of deception; and c) how the investigators will conduct the debriefing.

 

Resources from Medical Center or Department other than the PI's

Describe specifically those interdepartmental resources required to conduct a study.  Examples of departments frequently providing services for clinical research include: nursing service, hospital pharmacists, surgical pathology, laboratory technologists, radiology technologists, operating room site. The authorized administrator of that department should be contacted to determine feasibility of making such resources available in the manner required by the protocol.   An agreement confirming such arrangements should be documented by a letter of agreement for the IRB file or by  completion of the Clinical Trial Center Feasibility process (for industry-sponsored or PI-initiated studies), to be added as appendices to the IRB application.

 

Literature Cited

The protocol should reference only key literature.  Such references might provide background information on related in vitro studies, animal and/or human studies, as well as documentation of the rationale and of methods selected.

 

Helpful Links

 

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Grant Applications

 

Involving human subjects in research requires a carefully thought-out, detailed plan.  Grant applications to Federal sponsors require a complete description of such a plan as illustrated in the guidelines for Public Health Service Grants application.

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Prepare Recruitment Materials and Informed Consent Documents

 

Prepare recruitment materials (including phone scripts, posters, and advertisements) as needed, and informed consent documents (including assents for minors and decisionally impaired adults).  To avoid excessive translation costs, translated consent documents may wait until the English version has been approved.

 

Study Advertisement Materials

Since advertising (classified, display, posters, videos, television/radio commercials, etc.) is a method of recruitment and an extension of the informed consent process, the IRB reviews the information contained in the advertisement to determine that adequate protection is afforded in recruiting subjects.

In general, advertising to recruit subjects should be limited to:

  1. The purpose of the research
  2. Briefly stated eligibility requirements
  3. Straightforward and truthful description of benefits to subjects
  4. Location of the research and how to obtain further information.
  5. Name and address of principal investigator.

 

No claims should be made, either explicitly or implicitly, that the study treatment is safe, effective, or superior. Advertising should not use terms such as "new treatment," "new medication," or "new drug" without explaining that the test article is investigational. Advertisements should not promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation.

 

Recruitment Script

Investigators involved in recruitment should be thoroughly familiar with the study’s consent document which is the basis for introducing the study to prospective subjects.  If initial contact is by phone or by a delegated individual, a script of what will be said to introduce the study should be submitted for IRB review and approval.  Identify, if applicable, any individuals other than a study investigator who will assist with recruiting or consenting and provide a script for that individual to follow. 

Helpful Links

Telephone Script Recruitment Template (download)

 

California Experimental Subject Bill of Rights

Before consenting and enrolling individuals in a medical experiment (as defined in California Health and Safety code section 24174 , investigators must provide them with the California Experimental Subjects Bill of Rights. This document is to be signed and a copy provided to the subject.  For non-English speaking persons, provision should be made for discussion in a language they understand and a translated version of the document


 

Informed Consent

Provide a consent document following appropriate consent templates to help assure the content follows ethical and regulatory requirements, modifying as instructed to reflect the specific study.  The study design and populations involved may require that more than one consent be prepared and/or assent documents for minors and decisionally impaired.  See institutional policy and procedure H-30:  Informed Consent in Human Studies Research and H-30a: Procedures for Informed Consent in Human Studies Research.

Helpful Links


 

Debriefing Statement for Deception

If the study warrants use of deception or withholding of information during the consent process, subject to IRB concurrence, investigators should include a debriefing script or statement that indicates the information subjects will receive regarding their participation in the research.

 

HIPAA Privacy Authorization

If a research study is subject to the Privacy Rule and the investigator uses Protected Health Information (PHI) for research purposes,  an authorization document for this use must be prepared and submitted to the IRB (serving in its capacity as the institution’s Privacy Board).  In accord with State of California requirements, the PHI Authorization must be separate from the informed consent document. 

See LLU’s Privacy in Research page for more information.

Helpful Links

 

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Plan for IRB Review

 

Full Board or Administrative Review?

Before preparing an application, the PI should know whether the proposed research will receive Convened Board or administrative (Expedited or Exempt) review, in order to plan for related deadlines and submission mechanisms.   IRB staff may be consulted for guidance.

Helpful Links

 

 

How long does IRB Review Take?

IRB review takes 1-4 weeks depending on the nature of the study and the quality of the submission to the IRB. The process could be longer during months with fewer IRB meetings.  IRB review time can also be greatly affected by the length of time it takes investigators to respond to the IRB’s requests for clarification and corrections, so it's best to address these promptly.

Full Board Review.  The convened, Full Board meets twice monthly January through October, and monthly in November and December (see IRB Calendar for deadlines and meeting dates).  Results of Full Board review are usually made available to the Principal Investigator within 3 working days after the meeting.  

Exempt/Expedited Review.  Administrative reviews are conducted either by a single IRB member (usually the IRB Administrator on a first-come, first-served basis) or by a small review panel, depending on the study’s content.  (See list of panels and schedule of review.) 

Requests to accommodate deadlines not amenable to these time frames will be considered by exception.

 

How to Facilitate IRB Review

To minimize the time required to obtain IRB approval, investigators are strongly encouraged to follow these steps:

  1. Maintain active, current Human Studies Education certification. For convenience, this can be started prior to and maintained independent of IRB submission.

  2. Complete and submit the Research Conflict of Interest disclosures  for significant personnel listed in the study prior to IRB submission.

  3. Familiarize yourself with IRB guidance pertaining to Special Study Requirements prior to submission. If in doubt, contact the IRB office  for a consult.

  4. Complete the IRB Application carefully and completely. Principal investigators should review thoroughly all submissions prepared on their behalf. Most delays in IRB review result from incomplete or conflicting responses.

  5. Develop a time line for submission that allows adequate time for pertinent scientific review in accord with departmental policies as well as other related institutional reviews.


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Choose Appropriate IRB Application

 

Depending on the type of research conducted, the PI completes one of the following:


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Identify Study Personnel

 

Identify all individuals who will participate in the design, conduct, or reporting of any portion of this research project and assure that each is committed to the assigned role and:


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Consider Special Study Requirements

 

Special Populations

Review and adopt pertinent guidance regarding special populations such as:

 

Genetic Research

Human Stem Cell Research

Controlled Substances

Placebo Use in Psychopharmacology