Program on Prevention Outcomes and Practices

IRB eProtocol for Regular Review: Blank Template

IRB eProtocol for Regular Review: Blank Template

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a)      Qualified Staff: Please state and justify the number and qualifications of your study staff.

b)      Training: Describe the training you will provide to ensure that all persons assisting with the research are informed about the protocol and their research-related duties and functions.          

c)      Facilities: Please describe and justify.

d)      Sufficient Time: Explain whether you will have sufficient time to conduct and complete the research. Include how much time is required.

e)      Access to Target Population: Explain and justify whether you will have access to a population that will allow recruitment of the required number of participants.

f)        Access to Resources: State whether you have medical or psychological resources available that participants might require as a consequence of the research when applicable. Please describe these resources.

g)      Lead Investigator: Please explain (i) your role in coordinating the studies, (ii) procedures for routine communication with other sites, (iii) documentation of routine communications with other sites, (iv) planned management of communication of adverse outcomes, unexpected problems involving risk to participants or others, protocol modifications or interim findings.

 Protocol Information

1)      Purpose

a)      In layperson’s language state the purpose of the study in 3-5 sentences.

b)      State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of this new knowledge. 

c)      Explain why human subjects must be used for this project. (i.e. purpose of study is to test efficacy of investigational device in individuals with specific condition; purpose of study is to examine specific behavioral traits in humans in classroom or other environment). 

2)      Study Procedures

a)      Describe all the procedures, from screening through closeout, which the human subject must undergo in the research project, including study visits, drug treatments, randomization and the procedures that are part of standard of care.

 b)      Explain how the above research procedures are the least risky that can be performed consistent with sound research design.

 c)      State if deception will be used. If so, provide the rationale and describe debriefing procedures. Since you will not be fully informing the participant in your consent process and form, complete an alteration of consent (in section 13). Submit a debriefing script (in section 16). 

d)      State if audio or video recording will occur. Describe what will become of the recording after use, e.g., shown at scientific meetings, erased. Describe the final disposition of the recordings. 

e)      Describe alternative procedures or courses of treatment, if any, that might be advantageous to the participant. Describe potential risks and benefits associated with these. Any standard treatment that is being withheld must be disclosed in the consent process and form. (i.e. standard-of-care drug, different interventional procedure, no procedure or treatment, palliative care, other research studies).

f)        Will it be possible to continue the more (most) appropriate therapy for the participant(s) after the conclusion of the study? 

g)      Study Endpoint. What are the guidelines or end points by which you can evaluate the different treatments (i.e. study drug, device, procedure) during the study? If one proves to be clearly more effective than another (or others) during the course of a study, will the study be terminated before the projected total participant population has been enrolled? When will the study end if no important differences are detected?

3)      Background

a)      Describe past experimental and/or clinical findings leading to the formulation of the study.

b)      Describe any animal experimentation and findings leading to the formulation of the study.

4)      Radioisotopes or Radiation Machines

5)      Devices

6)      Drugs, Reagents, or Chemicals

7)      Medical Equipment for Human Subjects and Laboratory Animals

8)      Participant Population

a)      State the following: (i) the number of participants expected to be enrolled at Stanford-affiliated site(s); (ii)the total number of participants expected to enroll at all sites; (iii) the type of participants (i.e. students, patients with certain cancer, patients with certain cardiac condition) and the reasons for using such participants.

b)      State the age range, gender, and ethnic background of the participant population being recruited.

c)      State the number and rationale for involvement of potentially vulnerable subjects in the study (including children, pregnant women, economically and educationally disadvantaged, decisionally impaired, homeless people, employees and students). Specify the measures being taken to minimize the risks and the chance of harm to the potentially vulnerable subjects and the additional safeguards that have been included in the protocol to protect their rights and welfare.

d)      If women, minorities, or children are not included, a clear compelling rationale must be provided (e.g., disease does not occur in children, drug or device would interfere with normal growth and development, etc.).

e)      State the number, if any, of participants who are laboratory personnel, employees, and/or students. They should render the same written informed consent. If payment is allowed, they should also receive it. Please see Stanford University policy at http://www.stanford.edu/dept/DoR/rph/7-5.html).

f)        State the number, if any, of participants who are healthy volunteers. Provide rationale for the inclusion of healthy volunteers in this study. Specify any risks to which participants may possibly be exposed. Specify the measures being taken to minimize the risks and the chance of harm to the volunteers and the additional safeguards that have been included in the protocol to protect their rights and welfare.

g)      Describe how potential participants will be identified for recruitment (e.g., chart review, referral from individual's treating physician, responses to an ad). Describe how participants will be recruited and how they will initially learn about the research (e.g., clinics, advertising). Attach recruitment materials in Section #16 (Attachments). You may not contact potential participants prior to IRB approval.

h)      Inclusion and Exclusion Criteria.

 

Identify inclusion criteria.

 

 

 

Identify exclusion criteria.

 

 

i)        Describe your screening procedures, including how qualifying laboratory values will be obtained. If you are collecting personal health information prior to enrollment (e.g., telephone screening), please request a limited waiver of authorization (in section 15).

j)        Describe how you will be cognizant of other protocols in which participants might be enrolled. Please explain if participants will be enrolled in more than one study.

k)      Payment. Explain the amount and schedule of payment, if any, that will be paid for participation in the study. Substantiate that proposed payments are reasonable and commensurate with the expected contributions of participant and that they do not constitute undue pressure on the participant to volunteer for the research study. Include provisions for prorating payment.

l)        Costs. Please explain any costs that will be charged to the participant.

m)    Estimate the probable duration of the entire study. Also estimate the total time per participant for: (i) screening of participant; (ii) active participation in study; (iii) analysis of participant data.

9)      Risks

a)      For the following categories include a scientific estimate of the frequency, severity, and reversibility of potential risks. Wherever possible, include statistical incidence of complications and the mortality rate of proposed procedures. Where there has been insufficient time to accumulate significant data on risk, a statement to this effect should be included. (In describing these risks in the consent form to the subject it is helpful to use comparisons which are meaningful to persons unfamiliar with medical terminology.)

·              Investigational devices. –

·              Investigational drugs. Information about risks can often be found in the Investigator's brochure. –         

·              Commercially available drugs, reagents or chemicals. Information about risks can often be found            in the package insert. –

·              Procedures to be performed. Include all investigational, non-investigational and non-invasive      procedures (e.g., surgery, blood draws, treadmill tests). -

·              Radioisotopes/radiation-producing machines (e.g., X-rays, CT scans, fluoroscopy) and             associated risks. -

·              Physical well-being. -

·              Psychological well-being. -

·              Economic well-being. -

·              Social well-being. -

b)      In case of overseas research, describe qualifications/preparations that enable you to both estimate and minimize risks to participants.

c)      Describe the planned procedures for protecting against and minimizing all potential risks. Include the means for monitoring to detect hazards to the participant (and/or to a potential fetus if applicable). Include steps to minimize risks to the confidentiality of identifiable information.

d)      Explain the point at which the experiment will terminate. If appropriate, include the standards for the termination of the participation of the individual participant Also discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the participants.

e)      Data Safety and Monitoring Plan (DSMP).  See guidance on Data Safety and Monitoring.

Describe the following:

The type of data or events that are to be captured under the monitoring plan.

The Monitoring Entity (ME) that will be responsible for monitoring and the data collected, including data related to unanticipated problems and adverse events, and their respective roles (e.g., Stanford Cancer Center, GCRC, investigator, sponsor, coordinating or statistical center, independent medical monitor, DSMB/DSMC, or some other entity).  If there is no ME, then the Protocol Director (PD) is responsible for this function.

If the ME is not the Stanford Cancer Center or GCRC, provide information about the ME’s members (e.g., name, credentials, title, organization, contact information). 

The time frames for reporting adverse events and unanticipated problems to the ME. 

The frequency of assessments of data or events captured by the monitoring plan. 

Specific triggers or stopping rules that will dictate when some action is required.             

As appropriate, procedures for communicating to the IRB, the study sponsor, and other appropriate entities the outcome of the reviews by the ME. 

Select One:

            q This protocol will not utilize a Monitoring Entity.  I understand that as PD, it is my                                          responsibility to assess events and new information, and to report to the IRB as specified                                   in the guidance/research/documents/GuidanceUnanticipatedProblems.pdf Events and                             Information that Require Prompt Reporting to the IRB. 

            q This protocol will utilize a Monitoring Entity.  I understand as Protocol Director, it is my                                 responsibility to review reports from the Monitoring Entity and to report to the IRB those                       identified as unanticipated problems involving risks to participants or others according to                                    the criteria of being unexpected, related, and harmful, as specified in the guidance Events and Information that Require Prompt Reporting to the IRB. 

f)        Special Participant Populations – Children & Pregnant Women/Fetuses

10)  Benefits

a)      Describe the potential benefit(s) to be gained by the participants or by the acquisition of important knowledge which may benefit future participants, etc.

11)  Procedures to Maintain Confidentiality

a)      Describe procedures for protecting the privacy interests of participants. Additionally, include whether the conditions affecting interaction with the participants and data collection are adequate to protect privacy (e.g., recording physical measurements of pre-teens in a school-setting, eliciting private medical or financial information in a quasi-public setting).

 

b)      Describe how you will maintain the confidentiality of research records in a secure manner. Include (i) where and under what conditions study data will be kept; (ii) how samples and records will be labeled; (iii) who has access to data, and whether there are levels of access (e.g., restricted access to sensitive information); (iv) what security measures will be used for private information and sensitive information (e.g., locked file cabinet, safe transmittal and storage, protection against loss, theft, or access by unauthorized persons, statistical techniques, encryption); and (v) if a code is used, what measures will be taken to protect against deciphering?

c)      How will you educate research staff to ensure they appreciate the importance of confidentiality including being conscious of their oral and written communications in such situations as workplace conversation, insurance billing, lost or misplaced papers, and unsecured electronic documents?

d)      For this study, is it feasible to not collect and record protected health information (PHI) or other individually identifiable information (e.g., use anonymous data)?

e)      If you are using de-identified data or specimens, will you receive the data or specimens without identifiers? Who will be responsible for the de-identification? If x-rays or other digital images are used, explain how the images will be de-identified.

f)        Are the data coded in such a manner that you would be re-identify the participant if you needed to? Who maintains the key to this code? Does anyone on your research team have access to this code?

g)      If PHI or other individually identifiable information is needed, explain at what stage of the research you will collect and record it (e.g., screening and recruitment, or actual enrollment, before or after obtaining informed consent). Describe what PHI or other individually identifiable information you will need.

h)      Explain whether you will code or destroy PHI or other individually identifiable information at some stage of the research.

i)        List any outside parties to whom you may need to disclose PHI or other individually identifiable information collected in or derived from the study. Include, for example, a participant's personal physician(s), other participating study sites and research teams, insurer(s), the sponsor, government agency(ies) (including FDA if this is FDA-regulated research), the institutional review board or other oversight bodies, or any other person or group. Include the nature of the PHI or other individually identifiable information that may be disclosed.

12)  Potential Conflict of Interest – answer questions directly in eProtocol

13)  Consent Background – attach appropriate consent forms

a) Describe the informed consent process.  Include the following.

      (i) Who is obtaining the consent?

      (ii) When and where will consent be obtained?

      (iii) How much time will be devoted to consent discussion?

      (iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to                              participate and sign the written consent?

      (v) What steps are you taking to minimize the possibility of coercion and undue influence?

      (vi) If consent relates to children and if you have a reason for only one parent signing, provide that                                  rationale for IRB consideration.

b) What is the Procedure to assess understanding of the information contained in the consent? How will the information be provided to participants if they do not understand English or if they have a hearing impairment? See HRPP Chapter14.5 for guidance.

c) What steps are you taking to determine that potential participants are competent to participate in the decision-making process? If your study may enroll adults who are unable to consent, describe (i) how you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains the capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what provisions will be made for the assent of the participant.

14)  Assent Background (less than 18 years of age)

15)  HIPAA Background – attach any HIPAA waivers required

Limited Waiver of Authorization

a)      Please describe the protected health information needed to conduct screening or recruitment.

b)      Answer questions in eProtocol accordingly

c)      Please describe an adequate plan to protect any identifiers from improper use and disclosure.

d)      Please describe an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law.

16)  Attachments – attach all supporting documents (e.g., recruitment materials, assessment questionnaires, scripts, screens, etc.)

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