Adventist HealthCare



Please complete this entire 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:       |

|Name of Relying IRB: |      |

|Reviewing IRB Contact Information: |Name/Title:      /      |

| |Address:       |

| |City, State, Zip Code:      ,      ,       |

| |Telephone:       |

| |Email:       |

|Reviewing IRB Registration Number: |      |

|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 |

| Study Protocol |

| Relying IRB Approved Informed Consent Form(s) inclusive of required AHC wording |

| Subject Recruitment Materials |

| Reviewing IRB study approval letter |

| Reliance Agreement signed by the Reviewing IRB’s Institutional Official (if available) |

|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 |

|2. Total Number of Subjects, Records, and/or Specimens. |

|At this site:       |

|At all sites:       N/A |

|3. 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) | Fetuses |

|Students of PI or study staff |Mentally/Emotionally/Developmentally Impaired Persons |

|Students to be recruited in their educational setting |Seniors (over 65) |

|Employees directly supervised by investigators |Nursing Home residents recruited in the nursing home |

|Employees of Research Site or Sponsor |Educationally Disadvantaged Persons |

|“Healthy” Volunteers (i.e., study subjects who are not being diagnosed or |Economically Disadvantaged Persons |

|treated for a medical or psychological illness or disorder) |Physically Disabled/Handicapped Persons |

|Pregnant Women |Other Vulnerable Populations |

|Prisoners |If the research involves other “vulnerable” populations, (i.e., those who “are |

|Institutionalized Persons |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. |

|      |

|4. 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?) |

|      |

|Recruitment of Subjects |

|5. 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? |

|      |

|6. Avoiding Coercion or Undue 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 |

|7. 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. |

|      |

|8. 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? |

|      |

|9. 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 |

|10. 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? |

|      |

| |

|(b) 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.) |

|      |

|Research Related Injuries: |

|11. 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?       |

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