Protocol Name: Principal Investigator




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Protocol Name:




Principal Investigator:




Primary Contact Name/Contact Info:




Date Revised:




Study Number:






PROTOCOL TEMPLATE INSTRUCTIONS HRP-503


  • These instructions accompany the MSSM “Template Protocol” document and are intended to assist you in developing a human research protocol.

  • Using the MSSM “Template Protocol” document, prepare a document with the following sections.

  • Note that, depending on the nature of your research, certain questions, directions, or entire sections below may not be applicable. Provide information if and when applicable, and in cases where an entire section is not applicable, indicate this by marking the section “N/A”. Do not delete any sections.

  • For any items below that are already described in the sponsor’s protocol or other documents submitted with the application, you may simply reference the title and page numbers of these documents in the sections below, rather than cutting and pasting into this document..

  • When you write a protocol, keep an electronic copy. You will need to modify this copy when making changes.



    Header:

  • Protocol Title

Include the full protocol title as listed on the application form.

  • Investigator

Include the principal investigator’s name as listed on the Human Research Application form.

  • Date Revised

Indicate the date at which the protocol was last revised.

  • Study Number

Indicate the study number, when known. This may not be known at the initial submission.

  1. Objectives

Describe the purpose, specific aims, or objectives of the Human Research. State the hypotheses to be tested.

  1. Background

Provide the scientific or scholarly background for, rationale for, and significance of the Human Research based on the existing literature.

Describe the relevant prior experience and gaps in current knowledge.

Describe any relevant preliminary data.

Explain the significance of the Human Research in terms of why this Human Research important and how will it add to existing knowledge.

Describe the importance of the knowledge expected to result.

  1. Setting of the Human Research

Describe the sites at which your research team will conduct the research. If applicable, describe:

  • At which institutions or sites the research procedures will be performed by your research team (MSSM; if offsite, please specify).

  • The location(s) where potential subjects may be identified and recruited (if different than the above).

  • Composition and involvement of any community advisory board for research conducted outside of MSSM.

  • For research conducted outside MSSM and its research affiliates:

Site-specific regulations or customs affecting research.

Local scientific and ethical review structure.

  1. Resources Available to Conduct the Human Research

Explain the feasibility of meeting the recruitment goals of this project, and demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period. (For example, how many potential subjects do you have access to? What percentage of those potential subjects do you need to recruit? If this has been reviewed by a committee for recruitment feasibility [e.g. PR&MC], please indicate so.)

Describe the number and qualifications of your staff, their experience in conducting research, their knowledge of the local study sites, culture, and society.

For research conducted outside MSSM and its research affiliates, describe the facilities used for conducting the research.

Describe your process to ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

  1. Study Design

    1. Recruitment Methods

Describe the source of potential subjects.

Describe the methods that will be used to identify potential subjects (e.g. ResearchMatch.org).

Describe materials that will be used to recruit subjects. Include copies of these documents with the application. For advertisements, submit the final copy of printed advertisements. When advertisements are taped for broadcast, provide 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.

    1. Inclusion and Exclusion Criteria

Describe how you will screen for eligibility.

Describe the criteria that define who will be included or excluded in your final study sample.

(NOTE: You may not include members of vulnerable populations as subjects in your research unless you indicate this in your inclusion criteria.).

    1. Number of Subjects

Indicate the total number of subjects to be accrued locally. If applicable, distinguish between the number of subjects who are expected to be pre-screened, enrolled (consent obtained), randomized, and complete the research procedures (i.e., numbers of subjects excluding screen failures) and between subgroups of subjects (e.g. healthy volunteer, disease cohort).

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

    1. Study Timelines

Describe:

  • The duration of an individual subject’s participation in the study (including follow-up).

  • The duration anticipated to enroll all study subjects.

  • The estimated date for the investigators to complete this study (complete primary analyses)

    1. Endpoints

[Note: Endpoints are results, conditions or events associated with individual study subjects that are used to assess study treatments. Not all study designs involve them.]

Describe the primary and secondary study endpoints (i.e. outcomes used to judge the effectiveness of a treatment).

Describe any primary or secondary safety endpoints (i.e. events/results that would cause a study subject’s participation to end due to safety).

    1. Procedures Involved in the Human Research

Describe and explain the study design.

Describe the procedures being performed, and when they are performed, including procedures being performed to monitor subjects for safety or minimize risks. Include procedures being performed already for diagnostic or treatment purposes and differentiate between these and the procedures performed solely for the research.

Describe procedures taken to lessen the probability or magnitude of risks.

Describe the source records that will be used to collect data about subjects.

Describe what data will be collected including long-term follow-up.

    1. Specimen Banking

If specimens will be banked for future use, describe where the specimens will be stored, how long they will be stored, how the specimens will be accessed, and who will have access to the specimens.

List the information to be stored or associated with each specimen (including how the specimens are labeled/coded).

Describe the procedures to release specimens, including: the process to request a release, approvals required for release, who can obtain specimens, and the information to be provided with specimens.

    1. Data Management and Confidentiality

Describe the data and specimens to be sent out or received. As applicable, describe:

  • What information will be included in that data or associated with the specimens?

  • Where and how data and specimens will be stored.

  • How long the data will be stored.

  • Who will have access to the data?

  • Who is responsible for receipt or transmission of the data and specimens?

Describe the steps that will be taken secure the data (e.g., training, authorization of access, password protection, encryption, physical controls, certificates of confidentiality, and separation of identifiers and data) during storage, use, and transmission.

Describe any procedures that will be used for quality control of collected data.

Describe the data analysis plan, including any statistical procedures. Provide a power analysis, if applicable (e.g. pilot study).

    1. Provisions to Monitor the Data to Ensure the Safety of Subjects

This information is only required when Human Research involves more than minimal risk to subjects.

Part I describes the safety monitoring activities that will be undertaken in during the study. This should be completed for all studies that require more than the basic minimum DSMP.

Part II describes Data and Safety Monitoring Committees or Boards and should be completed when one is needed for the DSMP
Part I: Elements of a Data and Safety Monitoring Plan

1. List the name(s) of the individual(s) at MSSM who will be responsible for data and safety monitoring of this study. For each individual, indicate their role, name, title, and department information. The Principal Investigator may be the only monitor of a study.

If the qualifications of an individual to serve as a monitor are not contained in the PPHS application, they must be added to the DSMP either as a narrative description or as a CV.
MSSM Principal Monitor:

Indicate whether this person is the PI, a Team Member, or is Independent:

Last Name:

First Name:

Academic Title:

Department:

Mailing Address:

Phone:

Fax:

E-mail:


MSSM Additional Monitor:

Indicate whether this person is the PI, a Team Member, or is Independent:

Last Name:

First Name:

Academic Title:

Department:

Mailing Address:

Phone:

Fax:

E-mail:


2. Justify your choice of principal monitor in terms of the assessed risk to the research subject‘s health and wellbeing. In high risk studies when the principal monitor is independent of the study staff, indicate the individual’s credentials, relationship to the PI, and the rationale for selection.

3. List the specific items that will be monitored for safety (e.g., adverse events, subject compliance with the protocol, drop outs, etc.).

4. Indicate the frequency at which ACCUMULATED safety and data information (items listed in number 3 above and interim analysis of efficacy outcomes) will be reviewed by the monitor(s) or the Data Monitoring Committee (DMC). Although this information must be reviewed at least annually, the higher the study risks, the more frequently reviews must be scheduled.

5. Where applicable, describe rules which will guide interruption or alteration of the study design.

6. Where applicable, indicate dose selection procedures that will be used to minimize toxicity.

7. List any specialized grading system that will be used to evaluate adverse events (e.g., National Cancer Institute Common Toxicity Criteria).

8. Describe procedures that will be used to assure data accuracy and completeness.

9. Should a temporary or permanent suspension of your study occur, in addition to the

PPHS, indicate to whom (NIH, FDA, sponsor, IRB) will you report the occurrence.
Part II. Data Monitoring Committee/Data Safety Monitoring Board (DMC/DSMB)

When appropriate, attach a description of the DMC. Provide the number of members of the DMC, their names and area of professional expertise. DMC reports must be made available to the local PI and the MSSM PPHS. The report need not contain specifics of the study or data, but there must be assurance that subject safety is not being compromised and that the results of treatment do not warrant early termination of the study.

    1. Withdrawal of Subjects

Describe anticipated circumstances under which subjects will be withdrawn from the research without their consent.

Describe any procedures for orderly termination.

Describe procedures that will be followed when subjects withdraw from the research, including partial withdrawal from procedures with continued data collection.

  1. Risks to Subjects

Describe the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related to the subjects’ participation into the research. Do not only refer to the drug/device insert or investigational brochure. As relevant for the IRB’s consideration, describe the probability, magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, legal, and economic risks.

If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable.

If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become pregnant. Include risks to others (e.g. sexual partners) if applicable.

  1. Provisions for Research Related Harm/Injury

Describe the availability of medical or psychological resources that subjects might need as a result of any anticipated adverse events that may be known to be associated with the Human Research.

If the research involves more than minimal risk to subjects, explain any medical treatments that are available if research-related injury occurs, who will provide it, what will be provided, and who will pay for it.

  1. Potential Benefits to Subjects

Describe the potential benefits that individual subjects may experience from taking part in the research. Include, as may be useful for the IRB’s consideration, the probability, magnitude, and duration of the potential benefits.

Indicate if there is no direct benefit. Do not include benefits to society or others (this is already described in the Study Objectives above).

  1. Provisions to Protect the Privacy Interests of Subjects

[Note: This section is soliciting different information than the confidentiality information solicited in section #5h.]

Describe the steps that will be taken to protect subjects’ privacy interests, particularly a person’s desire to control how, and with whom, they interact and communicate, especially on issues that prospective research participants may deem sensitive or private. Consider privacy interests that may arise from the time participants are identified for recruitment until they complete study participation. Consider privacy interests that may arise in communications with the study subjects (e.g. phone messages, mail, etc), including through long-term follow-up.

Describe what steps you will take to make the subjects feel at ease with the research situation in terms of the questions being asked and the procedures being performed. “At ease” does not refer to physical discomfort, but the sense of intrusiveness a subject might experience in response to questions, examinations, and procedures.

Describe why it is acceptable and appropriate for members of the research team to approach the prospective participant about the research.

  1. Economic Impact on Subjects

Describe any foreseeable costs that subjects may incur through participation in the research (exclude billing for procedures that are part of clinical care e.g. copayments for studies that involve an overlap of clinical care & research).

In answering this question, the Office of Clinical Research must be consulted in determining the appropriate responsible party for subject care costs incurred as part of the clinical research study. Additional information can be found on the Mount Sinai Intranet “Manuals & Documents” for the Office of Clinical Research. http://intranet1.mountsinai.org/office_of_clinical_research/


  1. Payments to Subjects

Describe the amount and timing of any payments to subjects.

  1. Consent Process

Indicate whether you will you be obtaining consent. (If not, proceed to the Waiver or Alteration of the Consent Process section below). If you will be obtaining consent, describe:

  • The setting of the consent process.

  • Describe any waiting period available between informing the prospective subject and obtaining the consent.

  • If you will be following “SOP HRP-090 Informed Consent Process for Research”, simply indicate this. Otherwise, describe:

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

The time that will be devoted to the consent discussion.

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

Steps that will be taken to ensure the subjects’ understanding.

Describe any tools that will be utilized during the consent process

Children

Federal regulations define “children” as persons who have not attained the legal age for consent to treatments or procedures involved in the research [clinical investigation] under the applicable law of the jurisdiction in which the research [clinical investigation] will be conducted (45 CFR 46.402(a) and [21 CFR 50(o)]). If the Human Research involves children:

  • We recommend that you review the “CHECKLIST HRP-421 Criteria for Research Involving Children” to ensure that your protocol has sufficiently addressed these additional regulatory criteria for approval.

  • 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 Human Research under the applicable law of the jurisdiction in which the Human Research will be conducted (e.g., individuals under the age of 18 years).

NOTE: For research conducted in New York State, review “SOP HRP-013- Legally Authorized Representatives, Children, and Guardians” to be aware of which individuals in the state meet the DHHS and FDA definition of “children” in New York State.

NOTE: For research conducted outside of New York State, obtain consultation from Mount Sinai legal counsel as to the definition of “minor” in the jurisdiction(s) where you are performing your research, given the treatments and procedures involved in the Human Research. [Contact the PPHS Office regarding how to obtain a Legal consultation.] After receiving consultation with Legal, provide an explanation in this section about whether you will be enrolling subjects who are defined as minors in other jurisdictions and the basis for your conclusion that they are not legally capable of consenting to the treatments or procedures involved in the research.

  • Describe whether parental permission will be obtained from:

Both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

One parent even if the other parent is alive, known, competent, reasonably available, and shares legal responsibility for the care and custody of the child.

  • Describe whether permission will be obtained from individuals other than parents, and if so, who will be allowed to provide permission. Describe the process used to determine these individuals’ authority to consent to each child’s general medical care.

  • Indicate whether assent will be obtained from all, some, or none of the children. If assent will be obtained from some children, indicate which children will be required to assent.

  • When assent of children is obtained describe whether and how it will be documented.

  • Describe whether child subjects may be expected to attain legal age to consent to the procedures of the research prior to the completion of their participation in the research (including storage of samples). If so, describe the process that will be used to obtain their legal consent to continue participation in the study. Describe the timing of this process, and what will occur if consent is not obtained from the now-adult subjects.

Cognitively Impaired Adults

If the Human Research involves adults who may be unable to consent, describe the process to determine whether an individual is capable of consent.

If the Human Research involves cognitively impaired adults:

  • If permission of a legally authorized representative will be obtained:

List the individuals from whom permission will be obtained in order of priority. (E.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.)

For research conducted in New York State, review “SOP HRP-013 Legally Authorized Representatives, Children, and Guardians” to be aware of which individuals in the state meet the DHHS and FDA definition of “legally authorized representative.”

For research conducted outside of New York State, obtain consultation from Mount Sinai legal counsel as to the definition of “legally authorized representative” in the jurisdiction(s) where you are performing your research. [Contact the PPHS Office regarding how to obtain a Legal consultation.] After receiving consultation with Legal, provide an explanation in this section about which individuals are authorized under applicable law to consent on behalf of a prospective subject to their participation in the procedure(s) involved in this Human Research.

  • Describe the process for assent of the subjects. Indicate whether:

Assent will be required of all, some, or none of the subjects. If some, indicated, which subjects will be required to assent and which will not.

If assent will not be obtained from some or all subjects, an explanation of why not.

Describe whether assent of the subjects will be documented and the process to document assent.

Non-English Speaking Subjects

Indicate what language(s) other than English are understood by prospective subjects or representatives. If subjects who do not speak English will be enrolled, describe the process to ensure that the oral and written information provided to those subjects will be in that language. If you intend to exclude potential participants who do not speak English, provide a justification for doing so.

Waiver or Alteration of the Consent Process

If the Human Research involves a request for a waiver or alteration of the consent process, review the “CHECKLIST HRP-415 Criteria for Waiver or Alteration of the Consent Process” and make sure your submission provides adequate information for the IRB to assess the criteria for approval. It is highly recommended that you provide additional information here to address each of the criteria for approval (e.g. impracticability).

Examples of when a waiver or alteration of the consent process may be applicable:

  • Research that does not obtain consent from subjects

  • Research that omits some information that is required in the consent template

  • Research that involves deception

  • Research that involves obtaining private information about third parties who have not provided consent

  • Research that requests a waiver of the consent process for planned emergency research. Please review the “CHECKLIST HRP-424 Criteria for Waiver of the Consent Process for Planned Emergency Research” to ensure you have provided sufficient information for the IRB to make these determinations.




  1. Process to Document Consent in Writing

Describe whether and how consent of the subject will be documented in writing. If using the standard PPHS consent template, simply indicate this.

If the consent process will not be documented in writing (consent will be obtained but the subject or representative will not sign a consent document) review the “CHECKLIST HRP-416 Criteria for Waiver of Written Documentation of Consent” and address each of the criteria for approval. Describe whether you will be using a consent document without a signature page, some other kind of script, etc.

  1. Vulnerable Populations

Indicate specifically whether you will include or exclude each of the following populations:

Include

Exclude

Vulnerable Population Type







Adults unable to consent







Individuals who are not yet adults (e.g. infants, children, teenagers)







Wards of the State (e.g. foster children)







Pregnant women







Prisoners



  • If the Human Research involves cognitively impaired adults, review the “CHECKLIST HRP-422 Criteria for Research Involving Cognitively Impaired Adults” to ensure that your protocol has sufficiently addressed these additional regulatory criteria for approval.

  • If the Human Research involves persons who have not attained the legal age for consent to treatments or procedures involved in the research (“children”), review the “CHECKLIST HRP-421 Criteria for Research Involving Children” to ensure that your protocol has sufficiently addressed these additional regulatory criteria for approval.

  • If the Human Research involves pregnant women, review the “CHECKLISTHRP-418 Criteria for Research Involving Pregnant Women” to ensure that your protocol has sufficiently addressed these additional regulatory criteria for approval.

  • If the Human Research involves non-viable neonates or neonates of uncertain viability, review the “CHECKLIST HRP-419 Criteria for Research Involving Non-Viable Neonates” “CHECKLIST HRP-420 Criteria for Research Involving Neonates of Uncertain Viability” to ensure that your protocol has sufficiently addressed these additional regulatory criteria for approval.

  • If the Human Research involves Prisoners, review the “CHECKLIST HRP-417HHRPHRP Research Involving Prisoners” to ensure that your protocol has sufficiently addressed these additional regulatory criteria for approval

  • Describe other aspects of the subject population that may increase their vulnerability (home/institution-bound individuals; students participating in their professor’s research, cognitively-impaired minors, etc)

If the Human Research involves individuals who are vulnerable to coercion or undue influence, describe additional safeguards included to protect their rights and welfare.

  1. Multi-Site Human Research (Coordinating Center)

If this is a multi-site study where you are the lead investigator, describe the management of information (e.g., results, new information, unanticipated problems involving risk to subjects or others, or protocol modifications) among sites to protect subjects.

  1. Community-Based Participatory Research

(Note: “Community-based Participatory Research” is a collaborative approach to research that involves the community in all aspects of research process. Community-based Participatory Research begins with a research topic of importance to the community and has the aim of combining knowledge with action and achieving social change to improve health outcomes and eliminate health disparities. Simply recruiting participants from the community is not CBPR. If your research does not involve the community in all aspects of the research process, mark N/A)

Describe involvement of the community in the design and conduct of the research.

  1. Sharing of Results with Subjects

Describe whether results will be shared with subjects or others (e.g., the subject’s. their primary care physicians)), and if so, describe how it will be shared. As applicable, this may include individual patient results (genetic testing), incidental findings, or overall study findings.

  1. External IRB Review History

If you have previously submitted this protocol for review by an external IRB, provide the name of the reviewing IRB and the associated project identification number. Indicate whether this protocol was found to be “not approvable” by the external IRB. If so, provide details of the review including the date of review and the IRB contact information.


Revised 8/16/10




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