CUHS Template Guide
For use by University Area Investigators
FAS, GSE, HKS, HBS, SEAS, HLS, GSD, HDS, Extension School and Radcliffe Institute
Introduction: This document contains information for use by University Area investigators who are submitting information about their human subjects research for review by the Committee on the Use of Human Subjects in Research at Harvard University (CUHS), through the Electronic Submission, Tracking & Reporting system (ESTR).
This latest version reflects the new Protocol Template as of January 30, 2015, which has wording changes in several questions. CUHS will continue to accept submissions using the old Protocol Template through June, 2015.
This document has various links to different parts (for example, clicking on the page number in the Table of Contents will take you to that section). If you click on a link and want to go back to where you were originally, try Shift-F5 or the Back arrow (if it appears on your Quick-Access Toolbar).
Please contact CUHS with any questions you have about this document at 617-496-2847 or
Table of Contents
Study Submission Guide 1
CUHS Protocol Template. 1
Consent and Assent Templates 14
HRP-215 Not Human Subjects Research Determination Request form 18
Continuing review template (for renewal submissions or closure) 21
Appendix A: Exempt Research 21
Appendix B: Principal Investigator and Faculty Sponsor Assurance 23
Appendix C: Stamping of subject material 25
Appendix D: Required Ethics Training 25
Appendix E: More Than Minimal Risk Research 26
Appendix F: Course Projects 27
Appendix G: Audit-type Studies 28
Study Submission Guide
The Study Submission Guide gives general information about how to use the ESTR website to submit materials to CUHS. Additional help on ESTR is available from the ESTR Support Site. Briefly, you log into the system at irb.harvard.edu with your HUID and PIN, then interact with the system by entering basic information into one or more web-based SmartForms, and attaching documents that provide additional information. This Template Guide provides details about how to prepare such documents using the protocol template and consent form templates.
CUHS Protocol Template.
I. Use of the protocol template
- Research needing CUHS review. No activities constituting research involving human subjects may be carried out by a Harvard-affiliated researcher until the research has been reviewed and given either approval or an exemption determination. Many granting agencies require IRB review and approval before any funds are disbursed, and some may require that approval has been obtained at the time the proposal is submitted. Please be sure to allow sufficient time for the CUHS review in planning the schedule of your research.
Certain types of simple research with human subjects will qualify for an exempt determination by CUHS. Harvard policy requires that all human subjects research be reviewed. Appendix A provides specific guidance on how to use the CUHS Protocol Template if you believe your research may qualify for an exemption.
Research activities that may not begin before CUHS review and approval or exemption include recruitment, screening, and randomization. Gathering information in preparation for research is allowed, as long as you are not obtaining information about individuals. For example, you can contact someone at an organization to see whether they may be interested in cooperating with you, or have people take a draft version of your survey and tell you which questions are confusing, as long as you are not recording information about those people.
It is also important to note that Harvard policy requires student projects to be reviewed as research. If a student is conducting a project by gathering data about individuals that involves a systematic investigation about living individuals through intervention or interaction with those individuals, or through the collection of their identifiable private information, the project is subject to review by the CUHS, even if the activities do not meet the regulatory definition of research (activities designed to develop or contribute to generalizable knowledge). This applies both to projects assigned by the instructor of a course as part of the curriculum (Course Projects), and to projects undertaken independently for thesis or other reasons. Such student investigations should be submitted to CUHS by the instructor for Course Projects and by the student for other projects, using the CUHS Protocol Template. Note that student research often qualifies for an exemption determination.
If you believe that your project may not meet the definition of research involving human subjects, you should not use the protocol template. Instead, you have the following choices:
i. You may request a formal determination by filling out form HRP-215 Not Human Subjects Research Determination Request (see section 4) and submitting it to CUHS through ESTR.
ii. You may request an informal opinion by emailing a brief description of your project to .
iii. You do not have to contact CUHS if your assessment is that your project definitely does not constitute human subjects research.
- Submitting a protocol for review. Generally, the first step in completing an application is to prepare the protocol and any additional documents such as consent forms or recruitment flyers that will be attached to the SmartForm in ESTR. To prepare the protocol, download the protocol template from the CUHS web site, and save and edit it in Word on your computer. Be sure to give it an informative name, which will make sense when viewed in ESTR and listed on your approval letter, such as “Protocol for Smith preschool study.” Please note that the Yes/No boxes in the template must be filled in by typing an “x”; they are not clickable (because this functionality does not work with all versions of Microsoft Word). The checkboxes also may not line up correctly in other word-processing programs.
Almost all protocols require some attachments. Consent forms should be prepared as Word documents, each with an appropriate name, from one of the CUHS templates or samples, or from any existing consent materials, such as a recently-approved consent form from your lab. You should also note that if you believe your research is exempt, there are separate exempt consenting templates. Other materials besides consent forms that you may need to prepare as attachments include:
· Recruitment letters, posters, flyers or ads
· Debriefing material
· Interview guides
· Tests, surveys, or questionnaires
· Participant instructions
This Template Guide document contains information in addition to that found in the templates themselves about writing a protocol and consent form. When the protocol and other material have been prepared (and reviewed by others if required), you will submit the application through ESTR as follows: Log in to irb.harvard.edu using your HUID and PIN; on the left side of the screen, select “Create New Study”. Details about how to navigate the IRB online submission system are available separately, via the Study Submission Guide and the ESTR Support Site.
- Use of CUHS Protocol Template vs. HLMA Protocol Template. The CUHS Protocol Template is designed to be used for research conducted in the Harvard University Area, Cambridge/Allston campus. The main difference from the Harvard Longwood Medical Area (HLMA) Protocol Template is that several of the questions that primarily pertain to medical and/or greater than minimal risk research have been moved out of the template itself and into this guidance document. If your research is more than minimal risk, be sure to include all additional required information in Question 2.1. CUHS will accept submissions using the HLMA Protocol Template, but we are more likely to have to contact you for clarifications and additional information.
- Definition of minimal risk: 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.
II. General information section of the CUHS Protocol Template
a. Protocol #: enter the number used to identify this protocol, if known. ESTR generates a protocol number when you complete the first screen (the Basic Information webpage) of the SmartForm.
b. Version number or date: enter a number or date that identifies this version of the protocol. For version number, you may use sequential numbers (1, 2, 3…) or a system for major and minor changes (1.0, 1.1, 2.0, etc.)
c. Principal Investigator name: Enter the name of the Principal Investigator, and indicate his/her status at Harvard.
d. Faculty sponsor name: Non-faculty Principal Investigators must have a Faculty Sponsor. Faculty are defined as individuals who are permitted by their School to serve as Principal Investigator on applications for sponsored funding to be administered through the University. Check with your school or department for information on who is eligible to be a Faculty Sponsor, or contact CUHS for assistance. If the Faculty Sponsor is from a school that is not covered by CUHS, a separate application must be submitted to the Faculty Sponsor’s IRB in addition to the application to CUHS.
Please note that both the Principal Investigator and the Faculty Sponsor must provide assurance that the research will be carried out in compliance with applicable regulations and IRB requirements. If a protocol includes a Faculty Sponsor, when the Principal Investigator submits the study in ESTR, the Faculty Sponsor is notified that he/she must provide the assurance before the study is reviewed.
e. Other advisor name: If there is an advisor in addition to the faculty sponsor, indicate the name and status.
f. Protocol title: When naming the protocol, keep in mind that we recommend that the name appear on the consent form, so use wording that is appropriate for participants to see. Also, please make sure the same title is entered in the “Basic Information” webpage of the SmartForm. One way would be to copy and paste the title from the protocol template document into ESTR.
III. CUHS Protocol Template questions
1. Background/Hypothesis
1.1. Provide the scientific background, rationale for the study, and importance in adding to existing knowledge.
This section should provide a rationale for performing the research, by, for example, describing gaps in our current understanding and the importance of the knowledge expected to result.
2. Study Design
2.1. Provide a thorough description of all study procedures.
This section should go into detail about all procedures for the study related to the interaction or intervention with human subjects and/or their identifiable information. The clearer the description, the less chance there is that you will be asked for clarifications. For example, please be sure that what will be done for this research is explained and differentiated from activities that have already taken place or will be submitted for future review. Please note that details about recruitment and consent are asked in later questions.
· Certain types of simple research qualify for an exemption determination. Consult Appendix A for guidance about whether your research may qualify. See specific guidelines for question 2.1.
· Be sure to attach all relevant documents describing study procedures (surveys, interview guides, participant instructions, test instruments, etc.) to the “Supporting Documents” webpage.
· Appendix E lists the additional questions that must be answered in question 2.1 if your study is more than minimal risk
2.2. Indicate the duration of a participant’s involvement.
Include the time required for each procedure, and also the total length of time that the participant will be in the study. For example: Each interview will last 1 hour; participants will be interviewed three times over a six-month period. This would be the place to describe plans for recontacting participants at a later time and how you will provide a statement (for example, in the consent form) for them to initial to indicate that they agree to be recontacted.
2.3. Indicate the estimated number of participants, by subgroup if applicable.
Indicate the total number of participants you plan to recruit. Provide a breakdown by subgroup, if applicable, for example, 30 monolingual English speakers and 30 bilingual Spanish-English speakers.
2.4. List inclusion and exclusion criteria and describe any screening process.
Indicate the age range of your subjects. In addition, specify any other characteristics that will determine whether participants are eligible for the study.
If you are screening for eligibility, describe how and when you will find out the characteristic(s) used to determine eligibility, and be sure to attach any screening materials (preliminary surveys, brief interviews, oral scripts, email responses) to the “Supporting Documents” webpage. Obtaining screening information requires consent; if you are using an abbreviated consent process (not using a full consent form) prior to obtaining screening information, explain why in this section.
2.5. Does the study involve (a) deception (providing false information) or (b) incomplete disclosure (withholding information about some or all aspect of the research purpose or procedures in order to maintain the scientific integrity of the study)
No Yes: If yes, explain the rationale and the plans for protecting the participants (e.g., debriefing).
Be sure to attach any debriefing materials to the “Supporting Documents” webpage.
Deception involves provision of false or misleading information to subjects during consent and/or the research experiment, or gathering data by manipulating people who are unaware that they are in a research study. For the latter type of deception, please see specific instructions in Appendix G, Audit-type Studies.
Incomplete disclosure involves deliberate withholding of information about the real purpose of the research process or the nature of the research procedures in recruitment material, consenting material, or research instructions. Incomplete disclosure applies only if the withholding of information is part of the study design, not simply because a complete description of every aspect of the study would make the consenting process overly lengthy. Withholding information about risks or for any aspects of the research that might influence the subject’s decision to participate is not permitted.