NON-INTERVENTIONAL/METHODOLOGICAL

RESEARCH PROTOCOL TEMPLATE

(HRP-503b)

INSTRUCTIONS

This template should be used by social-behavioral and biomedical researchers to prepare a protocol document for any research involving various types of interactional or observational methodologies: observations, interviews, focus groups, surveys, program evaluations, quality of life or interactional research.

For red sections that may not be applicable to your research: replace the instructional text in blue with “N/A”

As you are writing the protocol, you may remove all blue instructions in italics so that they are not contained in the final version of your protocol.

NOTE:

  1. This protocol uses the term, “research” whereas some disciplines prefer and/or methodologies dictate other terms such as “pilot”, “evaluation”, “inquiry”, “methodologies”, “investigation”, “probing”, “examination”, “case study”, “ethnographic approach”, “planned methods”, etc.
  2. This protocol uses the term, “subjects” whereas some disciplines prefer and/or methodologies dictate other terms such as “participants”, “key informants”, “stakeholders”, “respondents”, “groups”, “individuals”, etc.
  3. This protocol uses the term, “data” whereas some disciplines prefer and/or methodologies dictate other terms as “observations”, “narratives”, “stories”, qualitative outcomes”, “content analysis”, “ideas/knowledge share”, “source documents”, “artifacts”, “findings”, etc.

STUDY INFORMATION

Title of Project:

Principal Investigator:

Name:

Department/School/Division

Contact Information: Telephone Number & Email Address

PROTOCOL VERSION NUMBER AND DATE:

Table of Contents
Skip To Section:Hold CTRL + Click (Below) To Follow Link in Blue
1.0 / Research Design
1.1 / Purpose/Specific Aims
1.2 / Research Significance
1.3 / Research Design and Methods
1.4 / Preliminary Data
1.5 / Sample Size Justification
1.6 / Study Variables
1.7 / Specimen Collection As A Primary Source
1.8 / Interviews, Focus Groups, or Surveysand/or Observations
2.0 / Project Management
2.1 / Research Staff and Qualifications
2.2 / Resources Available
2.3 / Research Sites
3.0 / Multi-Site Research Communication & Coordination
3.1 / Non-Rutgers Research Sites
4.0 / Research Data Source/s
4.1 / Primary Data – Subjects and Specimens
4.2 / Subject Selection and Enrollment Considerations
4.3 / Subject Randomization
4.4 / Secondary Subjects
4.5 / Number of Subjects
4.6 / Consent Procedures
4.7 / Special Consent Populations
4.8 / Economic Burden and/or Compensation
4.9 / Risks and Benefits to Subjects
4.10 / Secondary Data– Record/Chart Reviews, Databases, Tissue Banks, Etc.
4.11 / Chart/Record Review Selection
4.12 / Secondary Specimen Collection
5.0 / Special Considerations
5.1 / Health Insurance Portability and Accountability Act (HIPAA)
5.2 / Family Educational Rights and Privacy Act (FERPA)
5.3 / NJ Access to Medical Research Act
5.4 / Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
6.0 / Research Data Protection and Reporting
6.1 / Data Management and Confidentiality
6.2 / Data Security
6.3 / Data and Safety Monitoring
6.4 / Reporting Results
6.5 / Data Sharing
7.0 / Data and/or Specimen Banking
8.0 / Other Approvals/Authorizations
9.0 / Bibliography

1.0 Research Design

1.1 Purpose/Specific Aims

Clearly state the overall purpose of the study. [Note: IRB reviewers come from a diversity of backgrounds. Therefore, avoid the use of acronyms and highly technical language.]

A. Objectives

Create objectives—statements outlining specifically what will be achieved by the study—that derive directly from the overall purpose.

B. Hypotheses / Research Question(s)

Describe underlying reasons/motivations for this project and/or the research question (s) specific to the topic and/or populations being studied. ORExpress any scientific hypotheses—statements about expected relationships between variables—that are testable and that include measurable outcomes/endpoints as described in the Research Design and Methods section of the protocol. Hypotheses correspond directly to the objective(s).

1.2 Research Significance(Briefly describe the following in 500 words or less):

Provide the scholarly or scientific background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. Describe the relevant current context of the study and gaps in current knowledge.

***Do NOT include your full Dissertation/Grant/Thesis section here.

1.3 Research Design and Methods

This section should describe how you would accomplish the goals and objectives of the study, and the means by which the data will be collected. Identify and justify the type of research proposed: qualitative, quantitative or mixed method approach (e.g. experimental, correlational, survey, qualitative). Describe and explainthe study design (cross sectional, descriptive, case/control, cohort, observations, program evaluations, surveys, focus groups, interviews, quality of life/quality improvement, case/control, retrospective chart/record/secondary data review/ (e.g. pre-test /post / test control group design; prospective longitudinal cohort design)

A.Describe in order of occurrenceall researchproceduresbeing performed, when and where they are performed, and by whom. As applicable, include procedures being performed to monitor subjects for safety or minimize risks.

B.Define the duration of the study and the length of time each subject will participate in the study.

1.4 Preliminary Data

Describe any relevant preliminary data.

1.5Sample Size Justification

Projects using quantitative strategies should describe total sample size (including gender and minority considerations), expected accrual rates and sampling strategy (justified for testing the primary and/or secondary hypothesis). For project using qualitative strategies should describe the target rates.

1.6 Study Variables

(If this section does not apply to your research, replace the instructions below with “N/A”)

A. Independent Variables, Interventions, or Predictor Variables

An independent variable is the factor over which the researcher has control and is manipulating or is a variable used to predict outcomes. Describe any treatments or interventions to be compared for their effects on participants. Clearly differentiate interventions or procedures that are a part of standard of care from those that are experimental. In the case of chart reviews, indicate if you will be comparing specific treatments or other interventions performed in the past. For correlational studies, indicate what variables you will be using to predict outcomes or performance.

B. Dependent Variables or Outcome Measures

Dependent variable(s) are measurements you expect to change as a result of an intervention or a predictor variable. List and describe all outcome measures that “depend on” your treatment, manipulation, or predictor variables.

1.7 Specimen Collection as a Primary Source

(If this section does not apply to your research, replace the instructions below with “N/A”)

***This section should be completed if subject will be providing specimens/sample directly to the researcher e.g. biopsy, blood drawn, etc.

***Note any personnel transporting biological materials will need to provide documentation of the appropriate biosafety training.

A.What types of Specimen/Sample will be collected, where, and by whom?

B.How will the Specimen/Sample be transported and by whom?

C.Who will process the Specimen/Sample?

D.How long will the Specimen/Sample be kept?

E.How will the Specimen/Sample be destroyed upon study completion?

F.If Specimen/Sample will be banked for future use, what will be the process for providing investigators with access to the bank and how will this be tracked?

1.8Interviews, Focus Groups, Surveys, and/or Observations

(If this section does not apply to your research, replace the instructions below with “N/A”)

A. Administration

(For surveys, questionnaires and evaluations presented to groups and in settings such as high schools, focus group sessions or community treatment centers).Explain how the process will be administered, by whom, and who will oversee the process.

  • Timing and Frequency

Describe the approximate time and frequency for administering interviews, focus groups, surveys, evaluations and/or observations

  • Location

Specify where the Interviews, Focus Groups, Surveysand/or Observations will occur

  • Procedures For Audio And Visual Recording

Describe the procedure for audio and videotaping individual interviews and/or focus groups and the storage of the tapes.

  • Person Identifiers

Explain if the research involves the review of records (including public databases or registries) with identifiable private information. If so, describe the type of information gathered from the records and if identifiers will be collected and retained with the data after it is retrieved. Describe the kinds of identifiers to be obtained, (i.e. names, addresses) and how long the identifiers will be retained and justification for use.

B. Study Instruments

  • Discuss the particulars of the research instruments, questionnaires and other evaluation instruments in detail. Identify the variables of interest and study endpoints (where applicable). Provide validity and reliability data for selected measures. For well-known and generally accepted test instruments, these can be provided as a list with references; for a novel or newly developed instrument, Include the instrument, including all questions, with your application. Make sure the language in the study instruments is appropriate for the population and that the questions are appropriate for the research question.
  • For ethnographic studies, identify any study instruments to be used and describe in detail where, when and how the study will be conducted and who or what are the subjects of study. Detail whether the location is a public setting and what type of data will be observed.
  • For oral histories or interviews, provide the general framework for questioning and means of data collection. Interview procedures should be laid out in writing (interview guide) and clearly explained to subjects before interviews proceed.
  • If applicable, include any referral information in the event that a participant reveals that imminent danger, reports suicidal ideation and/or scores high on a depression or suicide scale.

2.0 Project Management

2.1 Research Staff and Qualifications

(Preliminary information about research staff will be provided in your eIRB Application)

Waiver Describe the qualifications (e.g., training, experience, oversight) of the study team to perform their role. When applicable describe their knowledge of the local study sites, culture, and society. Provide enough information to assure the IRB that you have qualified staff for the proposed research.

2.2 Resources Available

Describe other resources available to conduct the research: For example, as appropriate:

A. Facilities

Describe your lab facilities or office where the research will commence.

B. Medical or Psychological Resources

Describe the availability of medical or psychological resources that subjects might need as a result of an anticipated consequences of the human research.

C. Research Staff Training

Describe your process to ensure that all persons assisting with the research are adequately informed about the protocol, the research procedures, and their duties and functions.

2.3 Research Sites

List the sites where research activities will be conducted.

3.0 Multi-Site Research Communication & Coordination

(If this section does not apply to your research, replace the instructions below with “N/A”)

(To be completed when PI Is the Lead Investigator)

If this is a multi-site study describe the processes to ensure communication among sites, such as:

  1. All sites have the most current version of the protocol, consent document, and HIPAA authorization.
  2. All required approvals (initial, continuing review and modifications) have been obtained at each site (including approval by the site’s IRB of record).
  3. All modifications have been communicated to sites, and approved (including approval by the site’s IRB of record) before the modification is implemented.
  4. All engaged participating sites will safeguard data, including secure transmission of data, as required by local information security policies.
  5. All local site investigators conduct the study in accordance with applicable federal regulations and local laws.
  6. All non-compliance with the study protocol or applicable requirements will be reported in accordance with local policy.

3.1 Non-Rutgers Site Research

For research conducted outside of the organization and its affiliates describe: Site-specific regulations or customs affecting the research for research outside the organization and Local scientific and ethical review structure outside the organization.

4.0 Research Data Source/s

4.1 Primary Data: Subjects and Specimens

(If this section does not apply to your research, replace the instructions below with “N/A”)

(If your study will only contain secondary data sources, skip this section and go to: (Secondary Data-Section 4.10)

4.2 Subject Selection and Enrollment Considerations

A. Recruitment Details

Describe when, where, how and by whom potential subjects will be recruited.

B. Source of Subjects

Describe the source of subjects.

C. Method to Identify Potential Subjects

Describe the methods that will be used to identify potential subjects.

D. Subject Screening

Describe how individuals will be screened for eligibility and by whom.

  • Inclusion Criteria

Describe the target subject population. Provide all relevant demographic (e.g., age, ethnicity), biomedical (e.g., disease status, laboratory values, pregnancy) and behavioral characteristics (e.g., cognitive abilities, mood) relevant for inclusion and exclusion.

  • Exclusion Criteria

Describe what relevant demographic, biomedical or behavioral characteristics exclude persons from participating in your research. Provide clear justification(s) for exclusions. Note any efforts you will take to overcome any anticipated barriers to participation.

E. Recruitment Materials

Describe materials that will be used to recruit subjects through the use of snowball sampling, electronic or posted means (e.g., posting throughout the campus), oral announcements, etc.

(Attach copies of these documents with the application. For advertisements, attach the final copy of printed advertisements. When advertisements are taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape.)

  • Lead Site Recruitment Methods

If this is a multicenter study and subjects will be recruited by methods not under the control of the local site (e.g., call centers, national advertisements) describe those methods.

4.3 Subject Randomization

(If this section does not apply to your research, delete this section)

Describe how subjects will be randomized to groups.

4.4 Secondary Subjects

(If this section does not apply to your research, delete this section)

If others (e.g., family members) become secondary subjects as a result of the information provided by the primary subjects describe how such persons will be protected.(Provide details regarding how these subjects will be consented in Consent Procedures section of this document)

4.5 Number of Subjects

A. Total Number of Subjects

Indicate the total number of subjects to be accrued.

B. Total Number of Subjects If Multicenter Study

If this is a multicenter study, indicate the total study-wide number of subjects to be accrued across all sites.

4.6 Consent Procedures

A.Consent

  • Documenting Consent

If you will document consent in writing, provide a list of each document here and upload your consent document(s) in eIRB. For guidance see HRP-091.

  • Waiver of Documentation Of Consent

If you will obtain consent, but not document consent in writing, describe your process for ensuring informed consent. Attach a Consent Information Sheet. Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” to ensure that you have provided sufficient information.

  • Waiver or Alteration of Consent Process

(If this section does not apply to your research, replace the instructions below with “N/A”)

Confirm if you wish to request waiver or alteration of Consent Process. If yes, describe the process for situation when consent will not be obtained or certain required elements of consent are being altered. Summarize the key elements of the justification for a request for the waiver. (Review HRP-410 to ensure you have provided sufficient information for the IRB to make their determinations.)

  • Destruction of Identifiers

If a waiver of consent is granted, identifiers should be destroyed with no possibility of linking the data with these identifiers as soon as possible. Please explain your procedures for this task.

  • Use of Deception/Concealment

(If this section does not apply to your research, replace the instructions below with “N/A”)

For studies involving deception, a waiver/alteration of informed consent is being sought because subjects are either not informed of research participation or one of the elements of consent is not present (i.e. description of the purpose of the study). Deception/incomplete (concealment) disclosure are typically only acceptable in studies with no more than minimal risk.

  1. Please detail why this study is minimal risk and outline the reason (scientific validity) for using deception in this instance.
  2. Indicate if there is not any alternative to address the scientific question in a valid manner but to use deception/incomplete disclosure and state why other effective, non-deceptive approaches are not feasible.
  3. Please detail if you are debriefing participants, and if not, indicate why not.

B. Consent Process

  • Location of Consent Process

Indicate where the consent process will take place (e.g. research site, online, Skype, phone, etc.).

  • Roles for Individuals Involved in Consent

The role of the individuals listed in the application as being involved in the consent process.

  • Coercion or Undue Influence

Steps that will be taken to minimize the possibility of coercion or undue influence.

4.7 Special Consent Populations

(If this section does not apply to your research, replace the instructions below with “N/A”)

A. Minors-Subjects Who Are Not yet Adults

  • Criteria for Consent of Minors

Describe the criteria that will be used to determine whether a prospective subject has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (E.g., individuals under the age of 18 years).

  1. Wards of the State

For wards of the state, please see Toolkit HRP-416 for additional guidance and requirements.

  1. Research in NJ Involving Minors

For research conducted in the state of NJ, see guidance (HRP-013).

  1. Research Outside of NJ Involving Minors

For research conducted outside of the state, provide information that describes which persons have not attained the legal age for consent to treatments or procedures involved the research, under the applicable law of the jurisdiction in which research will be conducted. (HRP-013)