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Doc of Guidelines for �鶹ɫ��Ƭ Initial Application via Etrieve

Steps for Initial HSRB Application Submission via Etrieve

1. Review the HSRB website to confirm that you have all the documentation needed for your submission.
   1. It may be helpful to use the Word document (link on website) to type out your application that you can then copy and paste into the Etrieve form
   2. All supplemental documentation should be in PDF format. 
2. 2. Once ready to fill out the Initial HSRB Application, you will click on the application button on our website (or get into Etrieve via the �鶹ɫ��Ƭ Etrieve link)
3. This will take you to the Etrieve portal. You will not log in on this page but rather click the icon. 
4. This will take you to the log in page for �鶹ɫ��Ƭ Etrieve. You will enter your username and password here and this will take you into Etrieve.
5. You will then select “Forms”
6. And then click on HSRB application under the Research Tab
7. This will generate the HSRB Application form.  The form comes pre-populated with your name and some contact information.
8. If you are a student, your information will also be pre-populated, and you will be asked to provide your faculty PI information (don’t forget you will need to attach a letter of support!)
9. You will be asked to provide the same information that was previously part of the Qualtrics application. 
   1. Some buttons ask you to check what is relevant to your study.  These may expand to obtain more information
   2. There are also fields in which you can directly type (or copy from a word document).  If these are required, this will be noted.  
10. Once you have completed all the fields, you will be asked to check off all of the forms that you will submit as supplemental materials for your application.  Please select all that apply.
11. Please submit all supplemental materials using the attachment button.            
12. You will be able to submit multiple documents from your computer.  These documents should be in PDF format. 
13. Once this is complete. You will be prompted to sign the statement of ethics and the submission certification.  
14. You can now press submit.  If you have not checked all of the required boxes, the Etrieve system will alert you to the question that needs to be answered.  Once complete, the system will allow you to submit. 
15. Once submitted, HSRB will begin our review process.  If we have any questions, we will use the Etrieve system to ask and you can provide clarification, upload new documents, and respond to questions from the board.  
16. Once submitted, you can see where your submission is in the HSRB process by clicking on the History tab. 
17. Once approved (or if you chose to withdraw your application), you will be asked to sign a certification. You will receive an email notification in your �鶹ɫ��Ƭ email (or the email that you used in the application), indicating that you need to sign this document.  If your study is approved, this will be your approval letter.  
18. You will receive a final email to your �鶹ɫ��Ƭ email closing the application and indicating that your approval status. 

Other important features of the new application.

1. You can download your application or print using the buttons at the bottom of the screen.  This will be true at each stage of submission so once approved you can download and/or print the documents associated with the project – including the approval letter.  If you need a copy of your approval letter, you can get this document via this process. 
2. All your submitted packages will be available by clicking the Activity tab. If you are a faculty member supervising research, you will be able to see all of these packages. 

Thank you for taking the time to read this document.  Please don’t hesitate to outreach to us with any questions that you have!

Word Document Template of �鶹ɫ��Ƭ Initial Application

Guidelines for Preparing an �鶹ɫ��Ƭ HSRB Initial Application

(revised 8/16/2022)

This document guides you through the questions of the �鶹ɫ��Ƭ Human Subjects Research Board (HSRB) application.  It is highly recommended that you prepare the questions outlined below PRIOR to initiating your application in this document – you can then copy and paste into Etrieve.  

Failure to address questions and upload documents may result in delay in the review of your application and/or may require resubmission.

The HSRB Initial Application will be submitted as an Etrieve package.  The responses to this form will be written into the Etrieve form and supplemental material will be uploaded. 

PLEASE DO NOT BEGIN THE APPLICATION UNTIL YOU HAVE REVIEWED THE QUESTIONS BELOW AND HAVE ALL RESPONSES AND DOCUMENTS FULLY PREPARED FOR SUBMISSION.

NOTE regarding attachments:

For some of the questions on the survey, you will need to submit attachments, preferably as Microsoft Word (.doc, .docx) or Adobe Acrobat (.pdf) files.  Please be sure these documents are accessible and legible prior to your submission.  The questions requiring documentation are highlighted in text boxes in the outline below.

HSRB APPLICATION OUTLINE

Welcome to the �鶹ɫ��Ƭ Human Subjects Review Board (HSRB) application.  This form should be completed for the following types of applications:

• NEW:  You have never applied for HSRB approval for this research protocol. (Submitted via ETRIEVE)
• REVISED/APPEAL:  You have already submitted this protocol for approval and the HSRB has requested edits/modified information. (Submitted via Qualtrics for Fall 2022)
• RENEWAL:  This protocol was previously approved by the HSRB, but it has been more than one (1) year since the protocol ended/the protocol term limits have expired. (Submitted via Qualtrics for Fall 2022)

If you need to submit a Protocol update for a study that has already been approved, please use the link to the on the HSRB website. (Submitted via Qualtrics for Fall 2022)

1. Project title (Recommended length of 12 words/24 characters or less)
2. Your name
3. Your email
4. Your preferred name and title as identified for HSRB correspondences. Examples: Dr. Snow, Mr./Mrs./Ms. Snow, Charlotte/Ng/Carlos/Charles
5. Your �鶹ɫ��Ƭ affiliation
   1. Student, Staff, Faculty, I am not affiliated with �鶹ɫ��Ƭ
   2. If you are a student, you will need to attach a letter or email from your faculty advisor confirming that they have read and approved your research plan. 
   3. Suggested language: I have reviewed this completed application and I am satisfied that the proposed research and its measures are adequate for the protection of human subjects. To the best of my knowledge, all the information in this application is truthful.
   4. If you are not affiliated with �鶹ɫ��Ƭ, you must provide the name of your co-investigator(s) at �鶹ɫ��Ƭ.
6. List all �鶹ɫ��Ƭ and non-�鶹ɫ��Ƭ co-investigators and research team member, their preferred names/titles, emails, and institutional affiliations (if non-�鶹ɫ��Ƭ)
   1. Examples: Charlotte Snow, Dr. Snow, csnow@rwu.edu; Charles Snow, Charles, Charles.snow@gmail.com, Research Consortium of RI
7. CITI Training certificate or equivalent (required for each researcher/co-investigator for all projects) (pdf only)
   1. Instructions available on the HSRB website.
8. Submit as a single file the certificates of all co-investigators and research assistants earned by completing the CITI Social and Behavioral Research Training course 
   1. Note: If one or more of the researchers’ CITI certifications has expired, they will be required to renew their certificate prior to HSRB approval. 
9. Type of application.
   1. New: You have never applied for HSRB approval of this research protocol. (Submitted via Etrieve)
   2.  Revised application/appeal: You have already submitted this protocol for approval, and the HSRB has requested more information. (Submitted via Qualtrics for Fall 2022)
   3. Renewal: This research protocol was previously approved by the HSRB, but it has been more than one (1) year since the protocol ended/the protocol term limits have expired.  NOTE that additional information regarding the status of the original proposal may be requested). (Submitted via Qualtrics for Fall 2022)
   4. For Revised applications/appeals or Renewals, you will be prompted to enter the original HSRB protocol number.
10. Type of project (check all that apply).
    1. Basic or Applied Research (not classroom related—faculty/staff/graduate student project, student thesis, Honors capstone)
    2. Class project with research component (includes projects at the individual, group, or class level)
    3. Community-engagement (surveys, interviews, & activities part of involvement with community partners)
    4. Program evaluation (pre and/or post surveys of program effectiveness) 
    5. Assessment of teaching and learning
    6. Other (please explain)
    7. If a class project, you will be prompted to provide the course name and number and the course instructor’s name and email.
11. Is the research being funded from an external source?  
    1. If yes, you will be prompted to enter: Type of funding (federal, state/local, foundation/private, institutional/university); Name of funding source; Grant/project title
    2. You will also be prompted to upload a copy of the grant proposal and award letter (as a single file).
    3. If yes, please identify the funding source and if affiliated with the U.S. Department of Health and Human Services.  A list of the agencies affiliated with HHS can be found on their website here:    You must also attach a copy of your grant proposal and/or award letter.
12. Briefly summarize the topic of your research and describe the research goals and/’or hypotheses for your study. 
13. Briefly summarize, in non-technical language, the question(s) you are investigating. What is the purpose of the research? Responses should be 50 words or less.  
    1. OPTIONAL:  If you prefer, you may upload a summary of your background literature, goals, and hypotheses as an attachment.
14. Estimated sample size/number of participants.
    1. Please estimate the number of participants you intend to recruit as part of our research.   
15. Describe the process of participant recruitment, including the target population (s).  Be explicit regarding how the researchers will recruit participants and obtain informed consent.        
16. Do any of the researchers have any existing or prior relationships or affiliations with the participants and/or with community agencies or organizations from which participants will be recruited?
    1. No
    2. Yes
    3. If yes, please describe any affiliations the researchers have with either the participants and/or with the community agencies or organizations from which participants will be recruited.  Explain what steps will be taken to ensure the recruitment is noncoercive and any potential conflicts of interest are addressed.
17. Research involving participants from outside �鶹ɫ��Ƭ and that involves off-site data collection requires written permission from the cooperation institution.
18. Will you need permission from an agency, organization, or cooperating institution (other than �鶹ɫ��Ƭ) to conduct this study?
    1. No
    2. Yes
    3. If yes, please attach a copy of an original letter or email of permission or support from the organization(s) from which you will be recruiting participants and/or conducting your study.
19. Provide a summary of the research protocol.  This should include a description of the activities of BOTH participants and the researchers.  Please also specify the location(s) for all research activities.
    1. OPTIONAL: If you prefer, you may upload a summary of your research methodology and procedures as an attachment.
20. Select all methods of data collection you will use to perform your research.
    1. Survey: You will distribute an electronic or paper survey to participants.
    2. Archival: You will use information previously collected for another purpose and/or which is currently stored in a secure, restricted database.
    3. Ethnography/Observation/Participant Observation: You will utilize methods that involve watching and/or interacting with your participants in a naturalistic environment.
    4. Structure/semi-structured interviews: You will use scripts or interviews to ask participants questions or solicit narrative accounts.
    5. Experiment/Quasi-experiment: You are investigating the effects of different treatment conditions or protocols.
    6. Other: Please explain
    7. For each method chosen, you will be asked to submit copies of your materials (surveys, interview questions, experimental stimuli, etc.).  
    8. For archival data, you will be required to explain the data set you will be using, the nature of your secondary analyses, and any institutional permissions required to access the data set.
21. Please upload a copy of your informed consent.  The informed consent must include the name and contact information for the Principal Investigator for the study.  Templates of informed consent documents are posted on the HSRB website: Informed Consent Templates 
    1. If multiple consent forms are required (due to language translations, different sets of procedures, etc.), you must upload a copy of each version.
22. Will data be collected anonymously?
    1. Definition of anonymous: Collected in such a way that it can NEVER be associated with any individual including you as a researcher/PI.  You will have no knowledge of which participant provided which data.
    2.  No
    3. Yes
23. Will data be collected confidentially?
    1. Definition of confidential: You will protect your participants’ identifying information from access by anyone besides yourself and any co-investigators.
    2.  No 
    3. Yes
24. Will you make video and/or voice recordings or take photos as part of the research protocol?
    1. No
    2. Yes
25. Please explain how data will be coded, and what steps will be taken to remove participants’ identifying information and store data in a manner to ensure that no one can trace information back to a particular participant. [not required for studies in which data is collected anonymously].
    1. NOTE If video or audio recordings will be used, provide details regarding what additional steps will be taken to secure the data and ensure confidentiality.
26. Briefly summarize the plan for data management and data analysis.  Include a description of how data will be coded (if not specified above) and how long data will be stored.  Please also summarize preliminary plans for data analysis.
    1. NOTE: If the proposal will access archival data, please specify how the data analyses will expand upon previous research with this dataset to qualify as a “new” research project.
27. Please describe any potential benefits of participating in the research study.
28. Will incentives be offered to individuals for their participation in the research study?
    1. No
    2. Yes
       1. If yes, describe any incentives and how they will be awarded to participants.
29. According to the Office of Human Research Protections (OHRP), risk of harm as a result in participating in a study includes “physical, psychological, economic, or social harm.”  Does your study pose any potential risks to participants?
    1. No
    2. Yes
       1. If yes, describe any potential stressors to the participants, and the steps that will be taken to minimize the stressors and/or address potential risk of harm to participants.
30. Please indicate any potentially vulnerable participants included in your study, as defined by the Office of Human Research Projections (check all that apply).  
    1. As noted above, knowledge of the target populations guides the HSRB in the review process and application status (Exempt, Expedited, or Full), as defined by the Office of Human Research Protections (add cite here)
    2. Children (17 years or younger)
    3. Cognitively impaired persons
    4. Prisoners
    5. Pregnant women
    6. Elected or appointed officials or candidates for public office
    7. Other
    8. None of the above
    9. If other, describe the other potentially vulnerable populations included in this study.  
31. Please explain what special precautions will be employed to protect research participants.  If children are to be recruited, please include an asset form. 
    1. **It is recommended that researchers consult and directly reference . 
32. Will your study require deception?
    1.  No
    2. Yes
       1. If yes, briefly explain why deception is necessary for this study.  Explain what protocols will be utilized to debrief participants at the conclusion of the study and what measures will be taken to ensure any potential negative effects of the deception are addressed. 
       2. You will also be asked to upload a copy of the debriefing protocol to be used with your participants following the conclusion of the study.
33. OPTIONAL:  Additional/supplemental materials

Statement of Ethics and Submission Certification

(required final step in the application process)

I have read the �鶹ɫ��Ƭ Policy on Protection of Human Subjects and will comply with all of its ethical requirements. I certify that my research will include no other means for data collection beyond those that I have described in this application and have included in my materials. I certify that all the information in this application is truthful and that in the event any significant changes are made to this proposed study, I will inform the HSRB.

I have read this certification and, by submitting this application, agree to abide by its terms.  Type your name in the area below.

Doc of CITI Training Steps

CITI Training: Step by Step Enrollment CITI Training Steps 

9.14.22 1 

1.  
   1. In the upper righthand corner of the website you will see options to Login or Register.  
   2. If you have a log in from �鶹ɫ��Ƭ, or another university, please use that one and Login 
   3. If you are a new user, please click register. 
2. For new users,  
   1. you will be asked to select your organization.  Please select �鶹ɫ��Ƭ
   2. The next step, asks you to enter your name and contact information
   3. Then you will be asked to create a username and password, in addition to some security questions
   4. Step 4, asks you about where you are located and if you’d like to receive any additional information (the answer to this question is up to you)
   5. Step 5, asks about CEUs.  Unless you are a professional who needs CEUs (or collect CEUs for another reason), the answer to this question is usually no (you can always change your preference).  If you answer no, you will still receive the CITI certificate (once the course is complete): 
   6. In step 6, you are asked several important questions.  First you are asked to provide your institutional email.  Please use �鶹ɫ��Ƭ email for this: Next you will be asked your department and role.  If you are a student, please enter the department of your faculty research mentor. You will also be asked which course you plan to take.  Assuming that this is the 1st time you are taking the course (or your previous coursework has expired), you  will select: Basic Human Subjects- Social and Behavioral Focus. 
   7. The next section allows you to enroll in a course
      1. Question 1: asks about if you plan to conduct human subject’s research
      2. Question 2: asks about if you have taken the CITI training before 
      3. Question 3: Is related to public health research.  This is not required for HSRB but may be required for a public health course.  Your instructor will let you know if you need to check yes to this question.
      4. Question 4: Is related to IACUC.  This is lab sciences research that uses animals.  
      5. Question 5: You will skip unless you do research with animals and need this training 
      6. Question 6: Is related to the Responsible Conduct of Research.  If you would like additional information about the research process, this is a good course to take.
      7. Question 7: Is related to conducting research during COVID-19 and you are welcome to take this, if you’d like the information, but it is not required.  
   8. The next step asks you to finalize your registration
   9. This will take you to the page where you can see your affiliations and you can click on your coursework.  If you change institutions, you can add and remove affiliations on this page as well.  Once you click on view courses you should see the Basic Course. You are able to complete modules and save them to come back and finish later.  When you return, you will come back to this page and be able to resume the training.  On this page you will also be able see completed courses and print certificates.  
3. For returning users, once you log into the site, you will be taken to the affiliations home page:  
   1. On this page, you can add and remove affiliations as needed. 
   2. For �鶹ɫ��Ƭ related trainings, please click view courses
   3. When you look at your courses, if you do not see the course that you would like to add, please select the “add a course” tab at the bottom of this page
   4. This will take you to the course enrollment questionnaire.
   5. You will need to scroll down to see the questionnaire.  Your answers to these questions will help determine which courses you are assigned.  Please see 2g above for details.
   6. Please pay close attention to Question 2.  If, you have completed the CITI course be sure indicate this in Question 2
   7. The course(s) will then be added to you course list.  

Please feel free to contact HSRB (hsrb@rwu.edu) or Dr. Selby Conrad (sconrad@rwu.edu) for any additional questions that you may have.