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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