Please Complete This Entire Form. If a Sponsor Protocol Will Also Be Submitted, Please

Please complete this entire form. If a sponsor protocol will also be submitted, please refer to the appropriate section of the sponsor protocol rather than cutting and pasting the information (with the exception of the Abstract which should be included in this form), and provide all site-specificdetails in this form. If you have any questions, please contact the IRB Office at 301-315-3400.

Date Form Completed
Title of Research Project:
Acronym/Short Name:
Protocol Number:
Sponsor Name: / Mark if investigator-initiated
Address:
Phone: / Fax: / Email:
Principal Investigator:
Status: / AHC Employee / Other
Affiliation(s):
Address:
Phone: / Fax: / Email:
Study Responsibilities:
Sub-Investigator 1:
Status: / AHC Employee / Other
Affiliation(s):
Address:
Phone: / Fax: / Email:
Include on correspondence
Study Responsibilities:
Study Coordinator:
Status: / AHC Employee / Other
Affiliation(s):
Address:
Phone: / Fax: / Email:
Include on correspondence
Study Responsibilities:
Other Key Personnel*:
Status: / AHC Employee / Other
Affiliation(s):
Address:
Phone: / Fax: / Email:
Study Responsibilities:

* Key personnel are individuals who have direct contact with subjects or their identifiable data or specimens for research purposes. [Copy and paste the above tables as many times as necessary]

Location of Study: Please identify all location(s) where research activities may take place.
Shady Grove Medical Center / Washington Adventist Hospital
Behavioral Health & Wellness Services / The Lourie Center
Adventist HealthCare Rehabilitation Hospital / Other: ______
Departments/Labs: Please identify all locations within the selected entity where research activities will occur.
Operating Room / Emergency Department
Cardiac Catheterization Lab / Physician Office
Other (Please List):
Funding Source: Please detail how this study will be funded.
Not Funded (Please explain):
Internally Funded (Please indicate internal funding source):
Externally Funded
Industry Sponsored
Federally Funded (Please include a copy of the grant application.)
General Information
1. What documents are included with this research protocol?
Research Operations Evaluation (ROE) Study Feasibility Decision Form and Checklist
Sponsor Protocol: Date and Version #
Copy of Complete Grant (if applicable)
Informed Consent Form(s):Date and Version #
Request for Waiver of Informed Consent (Complete the Request for Waiver Form)
Assent Form(s):Date and Version #
Short Form Consent(s) and Written Summary:Date and Version #
HIPAA Information
Incorporated into the Consent Form OR Stand-Alone Document
Request for Waiver of HIPAA Authorization Form (Complete the Request for Waiver Form)
For All Trials involving Investigational Drugs:
Investigational Drug Form
Investigator’s Brochure
FDA Form 1572
Drug Insert(s)
FDA Correspondence if applicable
For All Trials involving Investigational Devices:
Investigational Device Form
Instructions for Use
Device Manuals
FDA Correspondence if applicable
Verification of Clinical Trial Registration on website
Required documents for all Research Team Members
Signed/Dated CVs
Appropriate Collaborative Institutional Training Initiative (CITI) training
Research Conflict of Interest Disclosure Form
Delegation of Authority Form
Required documents for all Principal and Sub-Investigators
Signed/Dated Certification Forms
Unaffiliated Investigator Agreement(s) required for all investigators not employed by AHC
Subject Recruitment Materials
Questionnaires/Surveys/SubjectDiaries
Other (describe)
2. If the research involves any of the following, check the appropriate boxes:
Radiation / Biological Agents
HIV/AIDS / Study using only Existing Data and/or Specimens
Post – Market Studies / Other List Type:
3. Abstract: Summarize the proposed research to include the purpose, the subject population, the study’s design type and the procedures:
4. Objectives/Specific Aims: Describe the scientific aims of the study, including the objectives of the study and/or the hypotheses to be tested and statistical methodology.
5. Background Information and Rationale: Include any information that led you to develop this study.
6. Subject Population
Inclusion/Exclusion Criteria:Describe the characteristics of the subject population, including age range and health status.
Inclusion Criteria:
Exclusion Criteria:
Total Number of Subjects, Records, and/or Specimens.
At this site:
At all sites: N/A
(c)Vulnerable Populations: Will the research involve any of the following types of vulnerable subjects? (If it is possible that a particular category of subjects would be involved in this research, please check the box.)
Children (under 18)
Students of PI or study staff
Students to be recruited in their educational setting
Employees directly supervised by investigators
Employees of Research Site or Sponsor
“Healthy” Volunteers (i.e., study subjects who are not being diagnosed or treated for a medical or psychological illness or disorder)
Pregnant Women
Prisoners
Institutionalized Persons / Fetuses
Mentally/Emotionally/Developmentally Impaired Persons
Seniors (over 65)
Nursing Home residents recruited in the nursing home
Educationally Disadvantaged Persons
Economically Disadvantaged Persons
Physically Disabled/Handicapped Persons
Other Vulnerable Populations
If the research involves other “vulnerable” populations, (i.e., those who “are likely to be vulnerable to coercion or undue influence”), describe below.
When research involves “vulnerable” populations, additional safeguards must be included in the study to protect the rights and welfare of these subjects. If any vulnerable populations were identified above, describe any additional safeguards utilized to protect the rights and welfare of these subjects and provide a justification for involvement of these populations.
(d) Will non-English speaking individuals be included in this research?
YES. A copy of any translated consent materials, along with documentation of certification of the translated materials, must be provided to the IRB for review and approval prior to the enrollment of any non-English speaking individuals.
NO. If non-English speaking persons are later identified for the study, translated documents must be submitted to the IRB for review prior to consenting subjects.
How will non-English speaking individuals be consented?
Using an accurate (certified) translation of the IRB-approved English consent form.
Orally, using a qualified translator to interpret the English IRB-approved consent form, and using an IRB-approved translated short form in a language understandable to the subject.
How will you communicate with the subject throughout the duration of the research? (For example, how will tests and procedures be described so the subject will know what to expect and how will the results of tests and procedures be communicated?)
7. Study Duration and Expected Subject Commitment:
Anticipated study start date:
Anticipated study completion date:
Expected duration of individual study subject’s commitment:
8. Study Design: Describe the study design (e.g., randomized, blinded, placebo controlled, control group used, etc.).
9. Study Procedures: Describe all study procedures. Distinguish between procedures that are consistent with the subject’s standard clinical care and those that are performed solely for research purposes.
10. Data Collection: Describe all data variables, information to be collected, and the source of the data. Attach any data collection forms or complete the table below adding as many lines as necessary.
Data Element/Variable / Source
11. Statistical Analysis
Sample Size Estimation: Provide the statistical justification for the number of subjects. Account for attrition, withdrawals, and dropouts in the sample size, as applicable.
Data Analysis: Outline the plan for analyzing the data and ensure the analysis plan is consistent with the research objective and methods. Include any sub-group analyses (e.g., gender or age group).
Risks/Benefits
12. Risk Classification:In your opinion, what is the overall risk of the research? (According to federal regulations, “minimal risk” means “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”)
Please note that it is ultimately the responsibility of the IRB to assign the risk level to research studies and this determination may differ from your classification.
Minimal Risk / Greater than Minimal Risk
13. Identification of Risks: What risks may result from participating in this research study?
14. Minimizing Risks: What procedure(s) will be utilized to prevent/minimize any potential risks and discomfort?
15. Incidental or Unexpected Findings: Describe the plan to address incidental or unexpected findings about individuals identified during their participation in the research, as appropriate.
16. Potential Benefits
(a)What potential benefits to the enrolled subjects may result from this research?
(b) What potential benefits to society may be expected from this research?
17. Alternatives to Research: What alternatives are available for this population should they choose not to participate?
18. Data and Safety Monitoring: Does the study have an independent Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC)?
YES Provide a description of the monitoring plan.
NO Describe the procedures for monitoring the ongoing progress of the research and reporting adverse events.
Recruitment of Subjects
19. Recruitment Procedures: Describe how potential subjects will be identified, contacted and recruited for the research study. Attach copies of any materials that will be used for recruiting purposes, including any talking points or advertisements.
(a) How and by whom will potential subjects be identified?
(b) How and by whom will potential subjects be contacted and/or recruited?
(c) How and by whom will eligibility (i.e., inclusion/exclusion) be determined?
20. Avoiding Coercion orUndue Influence: Describe how you will ensure that subjects are not potentially coerced into study participation and that they understand this is research and not standard of care treatment.
Will potential subjects be introduced to the research study on the same day research interventions will commence?
NO Provide details regarding the time window between the day of study introduction and the first day of study intervention.
YES Justify your plans for introducing the research study to subjects on the same day research interventions will commence.
Informed Consent (If no consenting will be done, please skip to item 28.)
21. Personnel Conducting the Consent Process: Who will be conducting the consent process? Identify by name and training the individual(s) authorized to consent potential subjects.
22. Process of Consent: Describe the environment and location where informed consent will be solicited, the timing of the process (e.g., in relation to hospital admission, surgery, medication, stressful events), the involvement of someone other than the investigator(s) to help explain the research, and the opportunity for the prospective subjects to discuss participation in the research with family, friends or other advisors before signing the consent form. If the research involves children, describe the process for obtaining assent (and submit the assent form), if applicable, and parental permission/consent.
(a) How, when and where will the consent process take place?
(b) How long will the potential subject have to make a decision regarding participation? How will the consent process be structured to enhance independent and thoughtful decision-making?
23. Capacity to Consent
(a) How will the subject’s capacity to consent be determined and by whom?
(b) Will the research involve subjects without the capacity to give informed consent and thus require that consent be obtained from a legally authorized representative?
YES NO
24. Comprehension of the Information Provided: The principal investigator (or approved designee) is responsible for assuring that prospective subjects or their legally authorized representatives have sufficient understanding of the research to make an informed decision about participation. The principal investigator (or approved designee) must ensure that prospective subjects understand that participation is entirely voluntary and that refusing to participate in this study will not preclude alternative medical treatment. It is important that the prospective subjects or their legally authorized representatives understand the purpose of the research, the nature and duration of the procedures, any risks and discomforts involved, the possible benefits to the subjects and others, and their right to withdraw consent at any time without penalty. Willingness to sign the consent form is not an adequate demonstration of their understanding.
(a)Who will determine that the subjects’ or their legally authorized representatives’ understand the research prior to obtaining signature?
(a)How will it be determined that the subjects’ or their legally authorized representatives’ understand the research prior to obtaining signature? (i.e. asking questions, teach-back method, etc.)
25. Withholding of Information/Placebos
(a)Will the study involve withholding of information (other than treatment group in a blinded study)?
NO YES
(b) For a study involving a placebo-controlled trial, will the subject be informed that he or she may receive a placebo?
NO YES N/A (not a placebo-controlled trial)
(c) If the study involves either withholding of information (other than treatment group in a blinded study) or placebos about which the subject will not be informed, explain and justify your strategy and describe your plans for a post-study debriefing (or explain why there should be no post-study debriefing).
Financial Considerations
26. Remuneration/Compensation: Will the subjects be compensated in any form (i.e., cash or check, gift cards, gift items) for their participation in the research?
NO YES Describe the form of compensation and the compensation schedule, including whether or not the compensation will be pro-rated.
27. Financial Obligations of Subjects
(a) Will the subject be charged for any procedures, tests or supplies that are for research purposes only and/or not considered standard clinical care (i.e., data gathering and tests performed to support FDA filings, which would not normally be done for patient care)?
NO YES Provide an explanation.
(b) Are there any additional costs to the subject that may result from participation in the protocol?
NO YES Provide an explanation.
(c) Will the institution or the study sponsor compensate the investigator or the investigator’s practice for his/her/its involvement in the study? A Research Conflict of Interest Disclosure Form must be completed and submitted for each investigator.
NO YES Is the compensation consistent with the following statement from the AMA Code of Ethics?
“Any financial compensation received from trial sponsors must be commensurate with theefforts of the physician performing the research. Financial compensation should be at fair market value and the rate of compensation per patient should not vary according to the volume of subjects enrolled by the physician.”
YES NO Provide a justification.
(d) If the investigator or the investigator’s practice receives payment as set forth above in 29(c), is this information included in the Informed Consent Form?
YES NO Provide a justification.
Research Related Injuries:
28. In the event of research related injuries, will the sponsor pay for the subject’s medical care and/or hospitalization?
YES Under what conditions?
NO Who will be responsible for such care?
Data Collection, Storage, and Confidentiality
29. How will data be collected and recorded? Will data be associated with personal identifiers, or will it be coded to protect personal privacy?
30. What methods and procedures will be used to safeguard the confidentiality of subjects and their data and to prevent unauthorized access to the data?
31. Will data with subject identifiers be released? If so, specify the persons, entities, and/or agencies to whom this information will be released.
32. What will happen to the data when the research is completed (i.e., will the information be maintained or destroyed)?
Equipment/ Support/Special Arrangements
33. Special Arrangements: Are special arrangements necessary or is any special equipment required for the study to proceed (e.g., certain type of refrigerator, radiology equipment, etc.) or personnel (e.g., someone certified and skilled in using a certain type of equipment)?
NO
YES Provide details and any correspondence with applicable departments (e.g., pharmacy, radiology)

AHC Site Protocol ApplicationPage 1 of 10
Version 8, August 25, 2017