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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 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
cuhs@fas.harvard.edu
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 ............................................................................................................... 29
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
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a. 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
cuhs@fas.harvard.edu.
iii. You do not have to contact CUHS if your assessment is that your project definitely does
not constitute human subjects research.
b. 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
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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.
c. 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.
d. 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 of the SmartForm. If you are filling
out this protocol template for an already approved study that was migrated into ESTR,
indicate the F-number here.
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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” page 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.
 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.
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 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 sixmonth 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 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.
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.
2.5. Does the study involve (a) deception (providing false information) or (b) incomplete disclosure
(withholding information about some aspect of the research purpose or procedures in order to
maintain the integrity of the study)
No
Yes: If yes, explain the rationale and the plans for debriefing participants. Be sure
to attach debriefing materials to the “Consent, Assent and HIPAA Authorization Materials”
page of the SmartForm.
Deception involves provision of false or misleading information to subjects during 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.
If your research involves deception or incomplete disclosure, explain (a) why prior disclosure would harm the
scientific validity of the study; (b) why the withheld information would not be expected to affect a subject's
decision about participation; and (c) whether and when subjects receive a debriefing. Debriefings should (a)
state in clear language that the participant was deceived (e.g., “We told you that you were playing a game with
another person but in fact you were playing against the computer.”) and (b) explain why the deception was
necessary. Optionally, the debriefing form may request that the participant not share this information with
other potential participants until the study is over (giving a date). If debriefing is not practicable, or is
inappropriate, explain why.
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In evaluating the need for debriefing in research involving incomplete disclosure, CUHS will consider whether
the incomplete disclosure would involve something a participant would care about. For example, if the
consent form states that the purpose of the research is to study factors that influence decision making, a
participant would probably not care if the factors are those explicitly gathered by study questionnaires, but
might care if the factor was the temperature of the room.
In evaluating whether to approve research involving deception, CUHS will consider the following potential
harms to participants:
 Participants may feel coerced to have acted against their will.
 If participants are observed without realizing it, they may feel their privacy has been invaded.
 The participant’s self-esteem may be damaged or they may feel ashamed, guilty, stressed, or
embarrassed.
 Participants may be forced to have knowledge about themselves that otherwise they might not want
to know.
 Participants may feel a loss of control, or may be distrustful/suspicious.
3. Recruitment Methods
3.1. Does the study involve the recruitment of participants?
No: If no, skip to 4.1.
Yes: If yes, indicate how, when, where, and by whom participants will be recruited. If you
are recruiting from a study pool, describe how you meet their requirements (see Template
Guide).
Recruitment means contacting or informing potential participants about the existence of the study. If you are
using an existing data set, for example, you would answer No to this question.
If you answer Yes, indicate how participants will be identified and contacted to inform them about the
research.
Requirements for Harvard study pools are found in the links below:
 Psychology Department Study Pool
 Harvard Decision Science Laboratory
Harvard Business School Computer Lab for Experimental Research
3.2. Are there any materials that will be used to recruit participants (e.g., emails, posters, oral
scripts)?
No
Yes: If yes, list the materials. Be sure to attach final copies to the “Supporting
Documents” page of the SmartForm.
All recruitment materials must be reviewed by CUHS because recruitment is the beginning of the process of
informing prospective participants about the research. Listing the materials here provides a way to check that
all appropriate materials are included in the review of the protocol. Remember to include the description of
the study as it will appear in an online listing such as the HIT description in Amazon’s Mechanical Turk or the
study pool listing.
An advertisement must meet the following criteria:
 It does NOT state or imply a certainty of favorable outcome or other benefits beyond what is outlined
in the consent document and the protocol.
 It does NOT promise “free treatment,” when the intent is only to say subjects will not be charged for
taking part in the research.
 It does NOT include exculpatory language. i.e., anything that suggests that the subjects waive their
rights by joining the study.
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It does NOT emphasize the payment or the amount to be paid, by such means as larger or bold type.
The advertisement is limited to the information prospective subjects need to determine their eligibility
and interest, such as:
o The name and address of the investigator or research facility
o The condition under study or the purpose of the research
o In summary form, the criteria that will be used to determine eligibility for the study
o A brief list of participation benefits, if any
o The time or other commitment required of the subjects
o The location of the research and the person or office to contact for further information
3.3. Will participants receive reimbursement or compensation in the form of money, gifts, incentives,
or raffles?
No
Yes: If yes, specify the amount, method and timing of disbursement. See Template
Guide for specific information on payments and a link to the Harvard University Financial
Policy on Human Subject Payments.
Provide a detailed description of the plans for paying participants. Indicate the monetary value of any gifts.
Include any conditions, such as requirement to submit receipts for parking, meals, etc. Describe how
compensation will be calculated if a participant withdraws. If you are providing a raffle or lottery, indicate the
approximate odds of winning. If any participant will receive more than $100, in most cases you must collect a
Social Security Number. See the Harvard University Financial Policy on Human Subject Payments.
Payments must meet the following criteria:
 All information concerning payment, including the amount and schedule of payments, is in the
informed consent document.
 The amount of payment and the proposed method and timing of disbursement is neither coercive nor
presents undue influence.
 For research with more than one interaction:
o Credit for payment accrues as the study progresses.
o Payment is not contingent upon completing the entire study.
o Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce
subjects to stay in the study when they would otherwise have withdrawn.
4. Study Setting
4.1. Is any of the research conducted outside the United States?
No
Yes: If yes, describe how you are ensuring that the research is appropriate
considering local regulations and customs. This should be either a formal review by a local
ethics board, Ministry of Health, etc., if appropriate, or a statement that a formal review is not
required along with your source of information that the proposed research is in accordance
with local customs and norms.
If the research is to be conducted outside the U.S., CUHS requires a local context review. This is satisfied if you
are obtaining approval from a local IRB (usually called “Ethics Board” outside the US). If not, you must explain
why such approval is not required, and describe how you are ensuring that the research is appropriate in the
local cultural context – this could be from your own knowledge and experience, or you may attach
documentation of this opinion from someone knowledgeable about the culture.
4.2. Are there any permissions that must be obtained from cooperating institutions, community
leaders, or individuals, including approval of an IRB or research ethics committee?
No
Yes: If yes, provide a list of the permissions (also attach copies to the “Supporting
Documents” page of the SmartForm).
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Permissions that may be required include those from an IRB with jurisdiction over the area where the research
is taking place, and also agreements from any institution or individual whose cooperation is required, such as
schools or NGOs. Describe the provisions for cooperation here and attach documentation of permission to the
“Supporting Documents” page of the SmartForm.
5. Available Resources
5.1. Describe the experience of the investigator with this kind of research and/or this population.
Describe the investigator’s experience relevant to the proposed type of research in the proposed setting.
5.2. Are there any additional study team members whose role in the research require special
qualifications in addition to ethics training (e.g., licensed clinical psychologist)?
No
Yes: If yes, describe.
Describe the required qualifications in addition to ethics training, such as professional credential (e.g., RN,
social worker), knowledge of local culture, specialized research experience (e.g., trained surveyor), etc.
5.3. Are provisions needed for medical and/or psychosocial support resources (e.g., in the event of
research-related stress or incidental findings)?
No
Yes: If yes, describe the provisions and their availability.
If there are potential adverse consequences of participation in the research, describe the resources for
addressing these consequences.
6. Vulnerable Populations
6.1. Are there any potentially vulnerable populations (minors, pregnant women, human fetuses,
neonates, prisoners, economically disadvantaged, employees or students of the investigator,
cognitively impaired, etc.)?
No
Yes: If yes, identify all vulnerable populations and describe safeguards to protect
their rights and welfare.
List any populations that require extra protections in the research and the appropriate safeguards you will
employ.
 Minors: The definition of a minor is an individual who is younger than the age of majority in their
local jurisdiction. In the United States, the age of majority is generally 18, but higher in some states
(e.g., 19 in Alabama). The age of majority can be found for other countries by a web search. A
parent or guardian generally must provide permission for a minor to participate in research; in
addition, the child generally must agree to be in the research if old enough to understand what it
means to assent. Describe these consent provisions in 7.1. or the rationale for any deviation from
these provisions. In particular,
o Permission: If permission will be obtained from individuals other than parents, explain who
will be allowed to provide permission. Describe the process used to determine these
individuals’ authority to provide permission.
o Assent: Minors cannot give informed consent for themselves, but they must assent as
appropriate for their age. In other words, if a parent gives permission for his or her child to
participate but the child doesn't want to, he or she doesn't participate. You should watch
for any signs during study procedures that a child may not want to continue. Assent
information can be given to a child in oral or written form, and must include ageappropriate information to help the child decide if s/he wants to participate or not. See the
CUHS website for a sample assent template. Generally, investigators should obtain assent
from individuals ages 7 years or older; however, if this is not appropriate for the specific
target population, please describe. When assent of children is obtained, describe whether
and how it will be documented.
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o
In longer-term studies, a participant may have been a minor when initially recruited, and
then may reach the local age of majority while still participating in the research. Describe
the procedures in place to obtain consent if this is a possibility for your research.
The Office for Human Research Protection has additional information about research with minors.
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Pregnant women, fetuses or neonates: if the research poses any risks to a fetus or neonate, or
specifically to a woman because she is pregnant, the mother and in some cases the father must be
informed about these risks and consent to the participation of the pregnant woman or neonates.
Prisoners: for research involving prisoners, please consult prisoner guidance from the Office for
Human Research Protections, and specify in this section how your research satisfies the
requirements
Note that research involving prisoners does not qualify for exemption.
Cognitively impaired: if some participants may not be able to provide informed consent for
themselves, you must make provisions for obtaining permission from a Legally-Authorized
Representative (LAR), and the assent of the participants if they are capable of understanding their
participation. You must be familiar with the local laws defining acceptable LARs.
Employees or students of the investigator: individuals in these groups may feel that they must
participate if approached by their supervisor or teacher. Describe the provisions that you will use to
ensure that if these groups are recruited, their participation is truly voluntary.
7. Consent Process
7.1. Will participants be asked to agree to be in the study?
No: If no, explain why not, then skip to 8.1.
Yes: If yes, describe the consenting process. If the study includes minors or others who
cannot consent for themselves, describe how you will obtain their assent and the consent of their
parent or guardian. Be sure to attach copies of appropriate documents to the “Consent, Assent
and HIPAA Authorization Materials” page of the SmartForm.
An active and knowledgeable agreement to participate in research is termed “informed consent,” which may
or may not involve obtaining a signature. Consent is a process involving understanding and agreement, not
someone signing a piece of paper. Informed consent is normally required for any interactions with subjects. If
you believe that your research qualifies for an exemption determination, see specific exempt consenting
requirements.
In this section, describe how and by whom consent will be obtained or explain why it will not be obtained (for
example, if there are no interactions with participants or if obtaining consent would be impracticable).
Describe the time that will be devoted to the initial consent discussion. Describe any waiting periods between
(a) informing the prospective participant and obtaining consent and (b) obtaining consent and carrying out the
study procedures. Describe any steps that will be taken to minimize the possibility of coercion or undue
influence.
If there is more than one interaction with participants, indicate how you will ensure participants understand
what the research is about and what their participation involves. Confirm that any new information that might
influence a participant’s decision to continue participation will be provided to participants, including reconsent where applicable.
7.2. Will the consenting process involve obtaining a signature?
Yes
No: If no, explain why not (there is no requirement to obtain a participant’s
signature for minimal risk research, see Template Guide).
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Signatures are not required for research that is no more than minimal risk, with the exception that signatures
are required if any of the procedures in the study are of a type that normally require written consent (such as
medical procedures, release of videotapes, etc.). If you plan not to obtain signatures, state that your research
involves no more than minimal risk and that no study procedures normally require written consent.
7.3. Will participants be offered a copy of the consenting information?
Yes
No: If no, explain why not.
Normally, a participant should be able to obtain a copy of the consenting information if it is something they
want. Check Yes if any of the following or similar procedures are planned:
 each participant will be given a copy of the consenting material (for example, if the process in the lab
includes making a photocopy for the participant of the signed consent form, or if consent forms are
mailed, two copies are included, one for participants to keep and one to sign and mail back)
 all participants will be told verbally that they may have a copy of the written consenting material if
they ask (signed or unsigned)
 a statement is included in online or emailed consent information that participants should print or save
a copy for their records
If you are not offering participants a copy of the informational material, check No and explain why not.
7.4. Are you recruiting any participants who are not fluent in English?
No
Yes: If yes, describe the provisions for communication.
Provisions for communication with participants who are not fluent in English may include providing translated
written materials, the presence of a translator during interactions, and/or that the investigator is fluent in the
language understood by the participants. For written subject materials such as consenting information, the IRB
approves the English-language version. After approval, the investigator must arrange for the translation of the
documents and submit a Translation Attestation Form. Be sure to include a version number and/or version
date within each document. Back-translation of foreign language consent forms is not required.
Translated versions of written consenting materials are required; oral translation during the consent
discussion is not sufficient.
8. Risks
8.1. Are there any reasonably foreseeable risks or discomforts to participants and/or
groups/communities?
No
Yes: If yes, indicate probability, magnitude, and duration of each (note that risks
may be physical, psychological, social, legal, and/or economic) and outline provisions to
minimize risk.
Note: if risks are more than minimal, there are additional questions you must answer, see the
Template Guide.
Describe risks or discomforts that are reasonably foreseeable from participating in the research. Also indicate
any provisions to minimize these risks or discomforts. For example, if questions may make a participant
uncomfortable, explain that they will be told they may decline to answer, or if sensitive information is being
collected, refer to the confidentiality protections in section 9. All risks, even those that are no more than
minimal, must be reduced to the lowest level possible. If you believe that your research qualifies for an
exemption determination, see specific exempt risk guidance.
To determine whether risks are more than minimal, see the definition of minimal risk above, as well as the
additional information you must include in the procedures section if the research is more than minimal risk.
9. Data Confidentiality
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9.1. Which category of information best describes the data you will be recording? (Please refer to
the Harvard Research Data Security Policy Protection Memo, at
http://www.security.harvard.edu/harvard-research-data-security-policy-protection-memo, for
additional information about what data are considered sensitive and the required data security
measures.)
Level 1: Either the information contains no direct or indirect identifiers, or participants
have been told that their data will not be confidential; skip to 10.1
Level 2: Non-sensitive identifiable information for which confidentiality has been promised;
describe provisions to maintain the confidentiality of identifiable data (commonly, paper
copies and audio or video tapes kept in a locked location, electronic copies stored on
password-protected computers).
Levels 3, 4 or 5: Sensitive identifiable information that could be damaging to the
participants if revealed; describe the protections you have developed in consultation with
the appropriate IT resource. (Please refer to the Template Guide for a description of the
differences between data security levels 3, 4, and 5.)
A typical way to protect confidentiality is to replace individually-identifiable information such as a name with a
random numerical identifier and have a separate document, usually referred to as the key code, linking the
identifiers and the names. Then only the key code needs to be protected at the highest level of security
appropriate to the sensitivity of the data. Once the key code is destroyed, the research information is no
longer considered identifiable and you may close the study.
CUHS may make a different assessment of the security level, in which case you will be contacted for further
clarification. Please note that if you believe your research qualifies for an exemption determination in category
2, the information security level must be 1 or 2.
Brief descriptions of security levels 3, 4 and 5 are below; for additional information, see
http://www.security.harvard.edu/harvard-research-data-security-policy-protection-memo.
If you are collecting sensitive information, you should consider obtaining a Certificate of Confidentiality that
protects your data from forced disclosure; see http://grants.nih.gov/grants/policy/coc/
INFORMATION SECURITY LEVEL 3: Sensitive information about individually identifiable people. Includes
individually identifiable information that, if disclosed, could reasonably be expected to be damaging to a
person’s reputation or to cause embarrassment. Examples: student record information protected by FERPA;
some medical record information.
INFORMATION SECURITY LEVEL 4: Information that would likely cause serious harm to individuals. Includes
individually identifiable High-Risk Confidential Information as defined by the Harvard Enterprise Information
Security Policy. Includes Social Security numbers as well as other individually identifiable research information
that, if disclosed, would likely cause risk of serious social, psychological, reputational, financial, legal, or other
harm to an individual or group. Examples: collecting information about stigmatizing health conditions.
INFORMATION SECURITY LEVEL 5: Information that would cause severe harm to an individual if disclosed.
Level 5 information includes individually identifiable information which if disclosed would likely cause risk of
criminal liability, loss of insurability or employability, or severe social, psychological, reputational, financial or
other harm to an individual or group. Examples: information covered by an agreement that requires that data
be stored or processed in a high security environment and on a computer not connected to the Harvard data
networks; certain identifiable medical records and identifiable genetic information categorized as extremely
sensitive.
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Note: Extremely sensitive research information must be stored and processed only in physically secure rooms
and not stored or processed on computers connected to an information network that extends outside the
room.
9.2. Describe i) plans for any transmission of data; ii) how long data will be stored; and iii) plans for
the data at the end of the storage period (how it will be destroyed, or if it will be returned to the
data provider).
If you have described these provisions in your answer to 9.1., indicate this here.
9.3. Indicate how research team members and/or other collaborators are permitted access to
information about study participants.
Distinguish between identifiable and de-identified data.
10. Benefits
10.1. Describe any potential benefits to study participants and to society.
Describe any benefits to participants or society from the research. If there are no direct benefits to
participants, say so. Of note, compensation is not a benefit and should not be addressed in this section.
11. Participant Privacy
11.1. Describe provisions to protect participants’ privacy (their desire to control access of others to
themselves, e.g., the use of a private interview room) and to minimize the intrusiveness of study
questions or procedures.
Privacy involves concerns that people have about allowing access to their persons (as opposed to
confidentiality, which refers to access to data about themselves). Appropriate privacy protections include only
asking questions or doing procedures necessary for the research, and preventing others from hearing or
observing research interactions, including recruiting and consenting. For online surveys asking sensitive
questions, it is appropriate to suggest in the consent form or study directions that the participant use a
computer where their screen cannot be observed.
12. Sharing Study Results
12.1. Is there a plan to share study results with individual participants and/or the participant
community?
No
Yes: If yes, describe the plan.
Typical plans to share results with individuals include providing investigator contact information for
participants to communicate their request to have results sent to them when available. Please note that
sending a results letter after the research is completed does not constitute research and therefore a study may
be closed even if the planned results letter has not yet been sent. A plan to share results with a participant
community is often appropriate for community-based or ethnographic research.
13. Multi-site Study Management
13.1. Is this a multi-site study?
No
Yes: If yes, indicate whether there is a coordinating research site and describe plans
for communication among sites regarding adverse events, interim results, protocol
modifications, monitoring of data, etc.
Multi-site studies involve carrying out the same protocol under different Principal Investigators at two or more
sites. If your research involves one researcher or research team who will travel to different places to collect
information, that process can be described at 2.1 and 4 above, and this question can be answered “No.” If this
is a multi-site study, describe the plan for communication among sites.
14. Devices
14.1. Does this study involve the use of a device subject to FDA regulations?
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No: If no, skip to 15.1
Yes, and the device is being used according to its labeled indication: Skip to 15.1
Yes, and the device is an Investigational Device: Describe why this is a non-significant risk
device study and why it qualifies either for an abbreviated IDE determination or for exemption
from the IDE requirements for in vitro diagnostic devices.
Please contact CUHS for help if you believe your research may involve a device subject to FDA regulations.
Recent examples include a test to diagnose a condition in a blood sample, and a software application for an
iPad to diagnose a brain condition.
15. HIPAA Privacy Protections
15.1. Are HIPAA privacy protections required? Mark Yes only if the investigator is at Harvard
University Health Services or data will be obtained from a hospital or health center (see
Template Guide).
No
Yes: If yes, include at least one of the following:
Describe plans for obtaining authorization to access protected health information.
Provide the rationale for a waiver of authorization or limited waiver of authorization
request.
Harvard University Health Services and Harvard School of Dental Medicine are covered entities at Harvard.
Harvard is otherwise not a HIPAA covered entity as defined by the HIPAA Privacy Rule. If, however, protected
health information (PHI) is derived from a Covered Entity, e.g. a hospital or community health center, for
purposes of this protocol, describe the plans of that covered entity to obtain authorization to access protected
health information or provide a rationale for requesting a waiver of authorization. If an authorization is
obtained, state whether it will be part of the consent form or a stand-alone document. If the authorization is
included in the consent document, be sure that it includes all required elements, and that the line above the
signature states that the signer is giving authorization for sharing information with the individuals listed in the
consent form. If requesting a waiver, address why it is not practical to obtain an authorization and why the
research cannot be conducted without obtaining PHI. Please contact CUHS for help if you need additional
clarification.
16. Establishing a Data and Specimen Bank
16.1. Does the study include establishing a repository for sharing data or specimens with other
researchers (this does not include contributing de-identified data to an existing repository)?
No: If no, there are no more questions.
Yes: If yes, identify what will be collected and stored, and what information will be
associated with the specimens.
Answer Yes only if the research involves creating a bank where data or specimens will be stored as a resource
to other investigators. Simply intending to share the de-identified results of the study with the larger research
community does not constitute setting up a data bank.
16.2. Describe where and how long the data/specimens will be stored and whether participants’
permission will be obtained to use the data/specimens in other future research projects.
16.3. Identify who may access data/specimens and how.
16.4. Will specimens and/or data be sent to research collaborators outside of Harvard?
No
Yes: If yes, describe the plan, and attach copies of any agreements to the “Supporting
Documents” page of the SmartForm.
16.5. Will specimens and/or data be received from collaborators outside of Harvard?
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No
Yes: If yes, describe the plan, and attach copies of any agreements to the “Supporting
Documents” page of the SmartForm.
Consent and Assent Templates
The CUHS website has several resources for preparing consenting material.
 Templates are the most general staring point and can be used for any type of minimal risk research.
Templates are available for
o Adult consent
o Parent permission
o Child assent
 Samples assume a particular type of research so certain portions are already filled in. Samples are
available for
o Non-exempt lab studies
o Non-exempt interviews
o Exempt surveys
o Exempt interviews
 Examples are completed example consent forms for fictitious non-exempt studies for
o Interviews of adults
o Online experiments with adults
These templates are appropriate only for research that is no more than minimal risk. If your research is
more than minimal risk, use the Longwood Medical Area consent form template or contact CUHS for
guidance.
CUHS will approve any consent form that contains all required elements; the elements do not have to
be in the same order or with the same formatting as the templates. If you already have a consent form
that has been used in CUHS-approved research, you may continue to use it as a template for new
studies, as long as all the required elements are present.
General issues:
 The adult consent form template is for use with people who can consent for themselves.
 The parent permission form template is for use with parents or guardians who are providing
permission for their children to participate in research. If the parents are also participating, use
a single form and edit it so that it describes what both the parent and child will do in the
research.
 The child assent template may be used for minors; generally, assent should be obtained from
children aged 7 and above; however, there is no requirement that the assent involve a written
form or a signature.
 Use the exempt samples for exempt research.
 The forms must not include any "exculpatory" language, i.e., anything that suggests that the
subjects waive their rights by signing.
 Using the Harvard name: Investigators may indicate their position at Harvard, but shall not
represent that the research is sponsored by the University or a department within the University
except by explicit arrangement with appropriate administrative authorities. The letterhead
should not imply that the consent form is a Harvard University consent form, nor that the study
is sponsored by Harvard University or a department within the University. See guidance on the
use of the Harvard name
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So, "researchers at Harvard" or "researchers in the Psychology Department at Harvard", or
"researchers at the XXX School at Harvard" are all fine. However "Harvard researchers are
studying…" or “The Psychology Department at Harvard is conducting a study…” are not.
Similarly, "the Physiology Lab in the Psychology Department at Harvard", or "Project Zero at
the Harvard Graduate School of Education" are acceptable, but not "the Harvard Physiology
Lab" or "the Harvard Project on XXX" unless you have obtained the appropriate administrative
permission from the Provost's Office.


Suggested language for the templates and samples is in regular font, with directions bracketed
in italics. Please double check that the final version submitted to CUHS is clean; that is, that all
brackets, italicized words and instruction boxes have been removed.
Additional edits to the templates and samples may be made as long as all required elements are
included.
Template sections (this applies to the consent and permission form templates; the sections are worded
as the consent form but also apply to the permission form).
1. Header table: We suggest that you include this header with the title of the study and the name
of the Principal Investigator, and optionally the Faculty Sponsor. Multiple researchers may be
listed, in which case, use the plural “Researchers.” The consent form should have a version
date; you may put it in the header table, or you may delete this row of the header table if you
put the version date in the footer. If the same study includes two or more different consent
forms, you may add a row identifying the group that will use the consent form or you may
include this information in the study title.
2. Participation is voluntary: this language is based on regulatory criteria for approval. If you
use different language, please make sure it includes the following statements:
 Participation is voluntary.
 Refusal to participate will involve no penalty or loss of benefits to which the subject is
otherwise entitled.
 The subject may discontinue participation at any time without penalty or loss of benefits to
which the subject is otherwise entitled.
If you wish, you may move this paragraph to a different location in the consent form.
3. What is the purpose of this research? Describe how this research will attempt to solve the
scientific problem
4. How long will I take part in this research? Describe the duration of participation, both the
time per visit and the total time the participant is in the study if there is more than one
interaction. If you are planning to re-contact participants in the future, include a statement for
them to initial if they would prefer not to be re-contacted.
5. What can I expect if I take part in this research? Describe all study procedures in this
section. Use language that the participants will understand. If applicable, include any
responsibilities of the participant.
6. What are the risks and possible discomforts? List reasonably foreseeable risks and
discomforts. You may include a description of how likely the risks are as well as any measures
taken to mitigate the risks.
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Examples of acceptable risk/discomfort language:
 There is a risk that information we collect about you may become public; however, we
have taken several measures to keep your information confidential.
 Some of the questions may make you uncomfortable. Please remember you can skip
any question or stop the interview at any time.
 There are no reasonably foreseeable risks to participating in this study.
7. Are there any benefits from being in this research study? This section is optional if there
are no expected benefits. Do not include compensation as a benefit; it belongs in a separate
section. If you have described the importance of the research in the section entitled “What is
the purpose of the research,” you do not have to repeat that as a benefit to society in this
section.
8. Will I be compensated for participating in this research? This section is optional if there is
no compensation. If there is compensation, provide a complete description of the amount,
method and timing, including any requirements such as providing receipts, and how
compensation will be calculated if the participant withdraws. If compensation includes a raffle
or lottery, indicate the approximate odds of winning. If any participant will receive more than
$100, in most cases you will be collecting their Social Security Number, so you should
describe how you will process that information. See the Harvard University Financial Policy on
Human Subject Payments.
9. If I take part in this research, how will my privacy be protected? What happens to the
information you collect?
Describe confidentiality protections, if any. Please note that it is not a requirement that data be
kept confidential, just that participants be informed of the plans. Include the following
information in this section, if applicable:
 If the researcher does not know the identity of participants (e.g., for Qualtrics), you may say,
“Your participation is anonymous, and your responses cannot be linked to your identity.” If
you are using Mechanical Turk, include: “Please make sure to mark your Amazon Profile as
private if you do not want it to be found from your Mechanical Turk Worker ID.”
 If the researcher will know the identity of participants, you may say, “Your responses will
be kept confidential,” and then go on to describe measures such as
o Conducting interviews in a private place (if appropriate to minimize coercion, state
“The person who gave me your name to contact you won’t know whether you agreed to
participate or not.”)
o Replacing names with an ID code and keeping the key linking the names and ID codes
in a secure location separate from the data
o Using encrypted and password-protected electronic files; storing paper data and audio
or videotapes in locked cabinets in locked offices
o Destroying identifying raw data and erasing recordings at appropriate times
o Describing the publication protections, such as “I won’t use your name or information
that would identify you in any publications or presentations.” Or, if you are requesting
permission to identify and/or quote participants, say that instead.
If identifiable information is being collected, include the following statement: “The information
with your name on it will be analyzed by the researcher(s) and may be reviewed by people
checking to see that the research is done properly.” If there are others besides the researchers
and IRB that may see identifiable data, include the sentence: “The information may also be
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seen by (translators, transcribers, thesis committee, FDA, and/or other federal agencies as
applicable.)”
10. If I have any questions, concerns or complaints about this research study, who can I talk
to? Provide contact information for the investigator (and faculty sponsor, if any). Provide
phone numbers, email addresses and mailing addresses. Include the CUHS contact paragraph in
all consent forms.
11. Statement of Consent and Signature. The statement of consent and signature are not required
for minimal risk research. If you are not obtaining a signature, delete this section of the
template.
Special circumstances
Online study: If you are conducting an online study, you may use:
Statement of Consent By pressing >Continue below, I agree to take part in this research.
Please save or print a copy of this form for your records.
Investigator signature: There is no requirement for the investigator and/or the person
conducting the informed consent discussion to sign the consent form, but such names and
signature lines may be included if desired.
Witness: If there will be witness to the consenting process, because of local practice, low
literacy participants, etc., include the following above the witness’s name, signature, and date:
My signature and date indicates that the information in the consent document and any other
written information was accurately explained to, and apparently understood by, the
participant or the participant’s legally authorized representative, and that informed consent
was freely given by the participant or the legally authorized representative.
Video release: If you are videotaping participants, you may include spaces for them to initial
whether or not they agree to specific ways you will use the videos. For example:
By initialing in the boxes below, I agree to allow the researchers to use my videos
for research purposes
for presentations to students or to researchers, without any identifying information, as
examples of [behavior, responses, etc.]
for presentation to the general public, without any identifying information, in [textbook
pictures, links on our lab’s website, portions of the videotape in a news special, etc.]
Assent form. Make sure that the language in the assent form is age-appropriate. You may choose
to have two assent forms, one for ages 7 to 12, and another for ages 13 to 17, with different levels
of detail. A signature is not required for assent.
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Exempt sample forms. Edit these samples for the specifics of your study. Do not leave any
brackets or italicized instructions in the final versions. You may use a printed copy of the form as
the vehicle for providing the researcher’s name and contact information, or you may use it as an
oral script and provide the contact information in another written form, such as a business card.
HRP-215 Not Human Subjects Research Determination Request form
Please note that if any answer on this form indicates that your planned activities meet the definition of
research with human subjects, then you should stop filling out this form, and instead, submit an
application using the CUHS Protocol Template.
Definition of human subjects research:
 Research is a systematic investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge.

A human subject is a living individual about whom an investigator (whether professional or
student) conducting research obtains (1) data through Intervention or Interaction with the
individual, or (2) information that is both Private Information and Identifiable Information.
For the purposes of this definition:
o Intervention is physical procedures by which data are gathered (for example,
venipuncture) and manipulations of the subject or the subject’s environment that are
performed for research purposes.
o Interaction is communication or interpersonal contact between investigator and subject.
o Private Information is information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, and
information which has been provided for specific purposes by an individual and which
the individual can reasonably expect will not be made public (for example, a medical
record).
o Identifiable Information is information that is individually identifiable (i.e., the identity
of the subject is or may readily be ascertained by the investigator or associated with the
information).
Form questions:
A. RESEARCH
As defined by Department of Health and Human Services’ (DHHS) regulations: “a systematic
investigation, including research development, testing and evaluation, designed to develop or contribute
to generalizable knowledge.”
 If all checked YES, the activities meet the DHHS definition
 If ANY checked NO, the activity does not meet this definition. Skip to Section E.
1. ☐Yes ☐No Is the activity an investigation? (Investigation: a searching inquiry for ascertaining facts;
detailed or careful examination)
2. ☐Yes ☐No Is the investigation systematic? (Systematic: having or involving a system, method, or
plan)?
3. ☐Yes ☐No Is the systematic investigation designed to develop or contribute to knowledge?
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(Designed: done with purpose and intent. Develop: to elaborate or expand in detail.
Contribute: to be an important factor in; help to cause. Knowledge: truths, facts,
information.)
4. ☐Yes ☐No Is the knowledge generalizable? (Generalizable: universally applicable)
Harvard policy is that student projects are reviewed as research. If a student is conducting a project by
gathering data about individuals outside of class 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 are not
designed to develop or contribute to generalizable knowledge. Therefore, student investigators will have to
submit an application for review using the CUHS Protocol Template, instead of submitting this form, even if
they would answer No to questions 3 and 4. Note that some student projects are Course Projects that are
submitted to CUHS by the instructor for review.
B. HUMAN SUBJECT
As defined by DHHS regulations: “a living individual, about whom an investigator (whether professional
or student) conducting research obtains (1) Data through intervention or interaction with the individual,
or (2) Identifiable private information.”
Check all that apply
1. ☐Yes ☐No The investigator will gather data about living individuals through intervention OR
interaction. For example, physical procedures or manipulations of those individuals or
their environment. (Intervention); Communication or interpersonal contact with the
individuals. (Interaction)
2. ☐Yes ☐No
The investigator will gather data about living individuals that is private. For
example, the data includes information about behavior that occurs in a context in which
an individual can reasonably expect that no observation or recording is taking place,
and information which has been provided for specific purposes by an individual and
which the individual can reasonably expect will not be made public (for example, a
medical record). (Private)
3. ☐Yes ☐No
The investigator will gather data about living individuals that is identifiable. For
example, the participant’s identity is or may be readily ascertained by the investigator,
or will be associated with the information; the research involves the use of coded*
data/specimens (Identifiable)
Be sure to explain in section E your basis for checking No to questions 1 to 3.
C. CODED DATA
*Coded means a living individual’s identifiable information such as name or social security number has been
replaced by a code, such as a number, letter, or combination thereof and there is a key to link the code to the
identifiable information of that individual. Coded data are considered identifiable under the Common Rule.
If research involves the use of coded data/specimens, that were NOT collected specifically for the
proposed research activity through an interaction or intervention with living individuals, then one of the
following must be true:
1. ☐Yes ☐No
The provider of the data/specimens will remove the code before sending the
data/specimens to the researcher.
2. ☐Yes ☐No
3. ☐Yes ☐No
OR
The holder of the key and investigator enter into an agreement prohibiting the release
of the key to the investigator under any circumstances, until the individuals are
deceased. Provide a copy of this agreement (informal email exchange is sufficient);
OR
The investigator has documentation of written policies and operating procedures from
a repository or data management center that prohibits the release of the key to the
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investigators under any circumstances, until the individuals are deceased (provide this
documentation);
OR
4. ☐Yes ☐No
There are other legal requirements prohibiting the release of the key to the investigator,
until the individuals are deceased
If data are coded, explain in section E why the coded specimens or data are not identifiable.
D. HUMAN SUBJECT (FDA Definition)
The FDA definition of human subject is a participant in a clinical trial of a drug or device. It is unlikely that
projects for CUHS review would be subject to this definition.
E. STUDY ACTIVITIES
Provide a response to each of the following questions. Indicate N/A where item is not applicable
1. Purpose, specific aims, and/or objectives:
2.
Target population:
3.
Procedures used to gather information (e.g., communication or interpersonal contact with
individuals, manipulation of individuals, manipulation of individual’s environment, or physical
procedures). Indicate if these procedures would be conducted as part of standard of care, regardless
of the research.
4.
Description of data/samples gathered about individuals without using interaction or intervention
including names of datasets, URLs, etc.
a) What data will be collected, how and by whom the data will be analyzed?
b) How were the data/samples originally gathered from individuals (e.g., obtained as part of another
IRB approved protocol at this institution/another institution or as a part of routine clinical
practice)?
c) Can the collected information be directly or indirectly associated/linked with individual
identities?
d) Can others directly or indirectly associate/link the collected information with individual
identities?
e) List and attach with submission a copy of any applicable agreements (e.g., Data Use Agreement –
DUA, an attestation from the data provider) that indicate that under no circumstances will you
have access to the identities (or links to identities) of individuals from whom the data was
collected.
Providing complete information will assist in the review of your application.
F. NIH GENOME-WIDE ASSOCIATION STUDY (GWAS)
Provide a response to each of the following questions. Indicate N/A where item is not applicable
☐Yes ☐No Do you plan to submit data to the NIH Genome-Wide Association Study data repository?
(Check with NIH)
If you checked YES above,
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1. Discuss the risks to individuals, their families, and groups or populations associated with the data to
be submitted.
2. Submit the following supporting documents:
 A copy of any relevant data sharing plans, for example, the data sharing plan that was part of your
grant application.
 A copy of the informed consent of study participants from whom the data was obtained.
 Documentation of IRB approval of the data collection.
Guidance on GWAS is available at http://gwas.nih.gov/index.html
Continuing review template (for renewal submissions or closure)
Continuing review and study closure are both submitted using the Continuing Review (CR) choice for
an active study in ESTR.
ESTR will start sending email notifications 60 days prior to the expiration date of the study, and will
continue until the study is re-approved, even if you have already submitted the Continuing Review. If
the study was migrated from HIRBERT, only basic information will be found in ESTR. The
investigator is responsible for submitting a modification in order to complete the required information
for migrated studies prior to submitting continuing review; see instructions for more information. This
process includes attaching the latest CUHS-approved versions of the application form, subject material
(consent, recruiting and debriefing materials), and attachments.
A study may be closed when all subjects have completed participation (including all follow-up
activities) and data analysis is complete or data analysis continues only on data that are no longer in
any way identifiable (which includes access to a keycode linking participants’ identities to their data).
In addition, a study should be closed when the Harvard affiliation of the principal investigator ends.
The template for continuing review provides a place to prepare the brief summary of the progress of
the study that is required as a document to be attached to the SmartForm. In addition, there are 14
questions that must be answered on the SmartForm. Any “Yes” answers to those questions need to be
explained in the template.
Appendix A: Exempt Research
Certain types of simple research with human subjects qualify for an exemption determination by
CUHS, mainly research on normal educational practices and surveys or interviews that don’t collect
information that is both identifiable and sensitive. Exempt research does not have to meet the Federal
standards for approval, but Harvard policy requires that the research be reviewed. A formal
determination that the research is exempt is required before the research can begin.
A large proportion of the initial applications to CUHS receive an exemption determination, mostly
categories 1 and 2 (see below for a description of the categories).
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Application process for potentially exempt research
There are two important differences in the requirements for exempt research:
1. For student research, a Faculty Sponsor is still required, but the Faculty Sponsor is not required
to take ethics training.
2. The consenting process must meet only an abbreviated set of requirements.
If you think that your research qualifies for an exemption, you should read the criteria listed below
carefully (and please contact CUHS if you have questions about whether your project fits the
definitions), and fill out and submit the CUHS Protocol Template through ESTR, using the following
specific directions:
1. Exempt guidance for question 2.1, Provide a thorough description of all study procedures:
describe how your procedures fit into the applicable exemption category. In particular, for
exemption category 2, explain why you are not collecting data that is both identifiable and
damaging if revealed. Describe the information that will be collected and attach your survey,
interview guide, etc. to the “Supporting Document” page of the SmartForm.
2. Exempt guidance for question 7.1, Will participants be asked to agree to be in the study?:
a. If you are interacting with participants, you must obtain their consent; however, you are
not required to provide a consent form that subjects will sign. Instead, you should
attach an information sheet or oral script that contains the following four elements: (1) a
description of the procedures (interview, survey, etc.): what questions will be asked,
how long it will take, whether the information will be confidential, etc.; (2) a statement
that the activities involve research; (3) a statement that participation is voluntary; and
(4) your name and contact information. The CUHS website has sample exempt
information sheets. Please note that if our review finds that the research does not
qualify as exempt, we will contact you to prepare and submit a full consent form, which
will lengthen the review process.
b. If you are not interacting with subjects (e.g., category 2 observations of public behavior,
category 4 use of existing data), say that you are not obtaining consent.
3. Exempt guidance for question 8, Risks. If there are any reasonably foreseeable risks, such as
any risk from a breach of confidentiality, your research is not exempt. You may describe
discomforts, such as not wanting to answer a question or becoming tired, and measures you are
taking to minimize discomforts such as emphasizing that any question can be skipped and the
participant can stop at any time.
4. Exempt guidance for question 9, Data Confidentiality. If you believe your research qualifies
for an exemption determination in category 2, the information security level must be 1 or 2.
5. Please note that certain answers preclude exemption, specifically studying prisoners (question
6) or interacting with children (question 6).
Common exemption categories
The full list of categories can be found at 45 CFR part 46.101(b)
1. Research conducted in established or commonly accepted educational settings, involving
normal educational practices. (Both the procedures involve normal education practices and
the objectives of the research involve normal educational practices.)
Note: To qualify as category 1, you must be investigating an educational practice that has
already been used and studying it in an educational setting, from pre-school through
graduate school and adult education.
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2. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
unless: (i) information obtained is recorded in such a manner that Human Subjects can be
identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of
the Human Subjects’ responses outside the research could reasonably place the subjects at
risk of criminal or civil liability or be damaging to the subjects’ financial standing,
employability, or reputation. If the research involves children, the procedures are limited to
(1) the observation of public behavior when the investigator(s) do not participate in the
activities being observed and (2) the use of educational tests.
Note: For a survey or interview to qualify as category 2, if must either ask no questions
where the answers could be damaging, or, if it does, you must be recording the answers
without identifiers, for example, by taking notes that do not include the participant’s name
or other identifiers, or by using an online system such as Qualtrics that prevents you from
linking the name or IP address of the participant with his or her responses.
4. Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens if the information is recorded by the
investigator in such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects.
Note: Research qualifies for category 4 if the existing data contains identifiers (if it doesn’t,
then the project is not human subjects research), and if you are seeing the identifiers but not
recording them (if you are recording identifiers, then this exempt category does not apply).
Obligations of Principal Investigators of Exempt Research
The determination that your research is exempt does not expire, and you will not file annual renewals.
Changes to the research may be made without notification or pre-review by CUHS, unless the changes
are such that the research might no longer meet the exemption criteria. Examples of changes that you
should not make unless they have been submitted and reviewed by CUHS include:
 You planned to interview adults only, but now you want to interview minors
 You planned to survey people online, but now you want to include experimental manipulations
 You planned to test students on a new math curriculum, but now you want to text them
encouraging messages before class exams
Appendix B: Principal Investigator and Faculty Sponsor Assurance
The Principal Investigator and Faculty Sponsor agree to follow IRB rules by submitting the
application to the IRB. The activity is called “Submit and Provide Assurance” in ESTR
(indicated by a red arrow), and this is what moves the application to the stage where CUHS can
start the review.
The following is an annotated version of the assurance that the Principal Investigator and
Faculty Sponsor is providing:
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If this study involves lecturer/instructor/student research where I am the faculty advisor, I will
oversee the research and ensure that the Principal Investigator complies with the following:
This is because the Faculty Sponsor is the one in the position to ultimately ensure
compliance with the IRB requirements.
As Principal Investigator, I certify the following:
1. I will not start Human Research activities until I have obtained all other required institutional
approvals, including local ethics committee review for international sites; and approvals of
departments or divisions that require approval prior to commencing research that involves their
resources. The PI is in the position to know what approvals are required and when they
have been obtained
2. I will ensure that there are adequate resources to carry out the research safely, e.g. sufficient
investigator time, equipment, and spacing. The PI must assure the minimization of any risks
to participants.
3. I will ensure that Research Staff are qualified (e.g., including but not limited to appropriate
training, education, expertise, credentials, protocol requirements and, when relevant,
privileges) to perform procedures and duties assigned to them during the study. The PI is
responsible for the adequacy of any study staff.
4. I will update the IRB office with any changes to the list of study personnel. All staff who
interact with human subjects or their identifiable data must be reported to the IRB and
have appropriate training.
5. I will personally conduct or supervise the Human Research. The PI must be familiar with
details of the conduct of the study
1. Conduct the Human Research in accordance with the relevant current protocol as
approved by the IRB. The approved protocol represents allowable activities.
2. When required by the IRB ensure that consent or permission is obtained in accordance
with the relevant current protocol as approved by the IRB. The description of the
consenting process in the approved protocol represents IRB requirements.
3. Not modify the Human Research without prior IRB review and approval unless necessary
to eliminate apparent immediate hazards to participants. NOTE: for research receiving an
exemption determination, prior IRB review is required only if the modification will
change the research so it no longer fits the parameters of exempt research.
4. Protect the rights, safety, and welfare of participants involved in the research. This is the
paramount responsibility of the PI.
6. I will submit to the IRB in a timely manner: NOTE: these apply to approved research, not
research receiving an exemption determination
1. Proposed modifications to the previously-approved Human Research.
2. A continuing review application (to avoid a lapse in approval).
2. A continuing review application when the Human Research is closed.
7. I will submit to the IRB any reportable new information within five business days. See
CUHS website.
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8. I will submit an updated Financial Interest Disclosure within ten days of discovering or
acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest. This
applies to any study staff with a new potential financial conflict.
9. I will not accept or provide payments to professionals in exchange for referrals of potential
participants ("finder's fees"). This typically occurs only in clinical trials, and “referrals”
specifically constitute medical referrals. Agreeing to this does not preclude, for example,
hiring consultants to identify potential organizations to be studied.
10. I will not accept payments designed to accelerate recruitment that were tied to the rate or
timing of enrollment ("bonus payments"). This typically occurs only in clinical trials.
11. I will comply with applicable federal and state regulations, ethical guidelines, and Harvard
Institutional polices, including the Institutional conflict of interest and Harvard Research Data
Security Policy.

To protect information I must have a strong password for each of my Harvard accounts;
including a log in for idle sessions and lock out screen for multiple failed log-in
attempts. Log in information will not be shared.

Any system storing level 2 information must have updated security patches and virus
protection. These systems will only be accessed by those with a current and IRB
approved research role. IRB approval is predicated on compliance with all
applicable rules, including Data Security policies.
12. I will maintain adequate and accurate records and make these records available to the IRB
or Quality Improvement Program for review. The IRB or Quality Improvement Program
may review records to audit for compliance.
Appendix C: Stamping of subject material
When subject material has been approved, it will appear as Final under the Study Documents tab in
ESTR. These documents will be in pdf format and have a stamp at the top indicating that they are
approved. CUHS policy is that the stamping is for investigator records, to identify the most recent
version, and it is recommended but not required that a participant be given a stamped consent form,
and online material must contain the same text as the stamped version, but does not itself have to be
stamped. The best way to make sure that the most recently approved version of all subject material is
used is to download the file as needed from the ESTR Study Document tab rather than making paper
copies in advance.
Appendix D: Required Ethics Training
Harvard policies require that all individuals who are involved in human subjects research must
complete training in the ethical conduct of research. This includes investigators and all study team
members who have contact with human subjects or their identifiable data. Faculty Sponsors of nonexempt research must also complete the training. The requirement may be satisfied by attending a
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CUHS-led training session or by obtaining CITI or NIH certification online. Certification is valid for
three years.
All individuals who complete an online training program should download and save a copy of the
certificate for their records. Some certificates also must be submitted to CUHS:
1. Certificates that do not need to be submitted:
 Any training reported to CUHS prior to June 26, 2013.
 CITI training carried out through Harvard University affiliation if a valid HUID was
entered into the CITI “employee number” field. (This information is uploaded
automatically every Friday into ESTR.)
 CUHS-led undergraduate training. (CUHS will enter the information into ESTR.)
2. Certificates that must be submitted if not reported before June 26, 2013:
 NIH Ethics training
 CITI training carried out without an HUID or through another affiliation
The first time the individual is listed on a study with training in category 2, attach the certificate to the
“Supporting Document” page of the SmartForm. Please contact CUHS if you have any questions.
Instructions and link to CITI (Collaborative Institutional Training Initiative)
Instructions for finding the Social & Behavioral Courses on the CITI web site.
Finding the BASIC course:


Register or Log-in; choose Harvard University (Cambridge/Allston campus). Be sure the
correct HUID is entered into Employee Number in your CITI profile.
At Main Menu > Add a course... > Human Research (Protection of Human Subjects) > Social
& Behavioral Research Investigators > Stage 1: Basic
Finding the REFRESHER course:


Log-in; choose Harvard University (Cambridge/Allston campus). Be sure the correct HUID is
entered into Employee Number in your CITI profile.
At Main Menu > Add a course... > Human Research (Protection of Human Subjects) > Social
& Behavioral Research Investigators > Stage 2: Refresher
Click here to get started
Link to NIH Ethics Training
Click here to get started
Appendix E: More Than Minimal Risk Research
The following additional issues must be addressed in question 2.1 if your study is MORE THAN
MINIMAL RISK:
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1. Describe your plan for monitoring the data to ensure the safety of participants. Describe the plans
to periodically evaluate the data collected regarding both harms and benefits to determine whether
participants remain safe. Describe: what data will be reviewed, including safety and efficacy data,
how safety information will be collected, the frequency of data collection, including when safety
data collection begins, the person or entity (e.g., a Data and Safety Monitoring Board) responsible
for reviewing the data, the frequency or periodicity of cumulative data review, statistical measures
for analyzing safety data to determine whether harm is occurring, and any conditions that would
trigger an immediate suspension of the research.
2. Include a sample size or power calculation. Describe the statistical method and analysis plan.
Describe the sample size and its scientific rationale, by site and key characteristics, e.g., participant
demographics.
3. Describe the feasibility of recruiting the required number of participants. Demonstrate (based on
retrospective data) a potential for recruiting the required number of eligible participants within the
set recruitment period and the time frame necessary to implement and complete the protocol.
4. Explain the time commitment that the investigators will devote to the research.
5. Describe the provisions for medical care and what, if any, compensation will be available in the
event of a research-related injury. Describe how participants will report research-related injuries
should they occur. Although Harvard’s policy is not to provide compensation for physical injuries
that result from study participation, medical treatment should be available including first aid,
emergency treatment and follow-up care as needed. If the research plan deviates from this policy,
provide appropriate justification.
6. Describe how the principal investigator will oversee the study team and ensure that all study team
members are adequately trained and qualified to carry out the research.
7. Describe how the available research facilities and equipment support the protocol’s aims
8. If participants may be withdrawn from the study without their consent, describe the circumstances
(such as failure to complete required procedures). If there are any special procedures that are
required in this case (such as return of equipment), describe them here.
9. If participants may incur costs as a result of participating in the study, state these costs
10. If the study involves a medical intervention
A. Differentiate routine clinical care from research procedures
B. Describe any long-term follow up procedures
C. Identify primary and secondary endpoints for effectiveness and safety
Appendix F: Course Projects
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The policies of the Committee on the Use of Human Subjects at Harvard University (CUHS) require it
to review projects conducted by student investigators who gather information about living individuals
through intervention or interaction with those individuals, or through the collection of their identifiable
private information, even if the activities are not designed to develop or contribute to generalizable
knowledge, and therefore do not meet the definition of research in the Federal regulations.
The instructor of a course who wants to assign or allow students to conduct projects involving human
subjects must complete a CUHS protocol template to describe the nature of the work to be conducted
by the students: who will participate, how participants will be recruited, what participants will be
asked to do, the consent process, possible risks and benefits, protections for confidentiality and
privacy, and other relevant information. Please note that the course project must not include activities
that involve more than minimal risk to participants, defined as “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.”
The title of the protocol should start with the words “Course Projects for.” The Study Design section of
the protocol should include a description of:
1. how proposed student projects will be reviewed by the course teaching staff, typically a
statement that students will complete a CUHS protocol template that will be revised if needed
after being assessed by the teaching staff,
2. how students will prepare consent materials, typically a statement that students will use the
appropriate CUHS sample, and
3. how students will be instructed about protecting human subjects, typically by attaching or
including an excerpt from the course syllabus.
The course projects protocol template, along with sample consenting and recruiting material if
appropriate, is submitted to CUHS through the electronic system (ESTR).
All members of the course teaching staff, including the person named as investigator for the course
projects protocol, must complete required ethics training. If the investigator is not a faculty member in
his or her school (for FAS, a Senior Lecturer or above; other schools have similar requirements), then
a Faculty Sponsor is required who will assume ultimate responsibility for the conduct of the student
work with human subjects.
CUHS will review the submitted course project protocol, request any needed clarifications or changes,
and if satisfactory, issue a determination that the protocol does not represent Human Subjects Research
because the activities are not designed to develop or contribute to generalizable knowledge. Additional
IRB review of the course project is not required; however, if the instructor plans to change the course
beyond the boundaries of the activities that were the basis for the original determination, a new or
revised course projects protocol must be submitted.
In the course for which the determination has been obtained, if a student project falls outside the
boundaries of activities described in the course project protocol, or involves more than minimal risk to
human subjects, the student must complete CUHS required ethics training and submit a separate
protocol to CUHS for review, and the student may not start the project until approval or an exemption
determination has been obtained from CUHS.
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If a student were to decide after collecting data that s/he would like to try to publish the information,
s/he would submit an application to CUHS for the analysis of data collected for non-research purposes,
and, if appropriate, a separate application to continue the project if s/he wanted to collect information
in addition to the data obtained for the course project.
CUHS Policies and Procedures for student human subjects research, both course projects and
independent studies and senior thesis projects, are found at section 16.5 of the CUHS Policies and
Procedures.
Appendix G: Audit-type Studies
Audit-type studies refer to a category of research in which the subjects are performing the normal
duties of their job, and the researcher is presenting fictitious instances for the subject to process. A
typical example is where the researcher submits fake resumes to listed job openings in order to
determine what factors influence whether the fictitious person is contacted.
Such studies fit the category of human subjects research because the researcher is manipulating the
subjects and recording their behavior. The fact that the researcher may not know the identity of the
subjects does not mean that there are no subjects.
Because audit-type studies do not obtain the consent of the subject, the IRB must grant a waiver of the
requirement for consent. The investigator should address the following points in question 2.5 of the
protocol template, to assist the IRB in determining whether the study qualifies for a waiver of
informed consent:
1. Are the rights and welfare of the subjects adversely affected?
Specifically address issues of (a) how much of an additional burden the study will impose on subjects
and their employers and (b) what is the likelihood that the subject’s behavior will be revealed and what
are the consequences if their behavior were to be revealed.
The likelihood is addressed in terms of whether data are recorded in such a way that a subject could be
identified, and, if so, how are those data protected (i.e., to what data security level are they stored,
when are they destroyed – it is recommended that identifying information not be retained for more
than one month). The consequences are addressed in terms of whether the behavior (e.g., contacting or
not contacting a job applicant) would potentially be embarrassing to the subject and/or the employer.
2. Could the research practicably be carried out without the waiver?
Describe why informing the subjects about the study would invalidate the results. This is often
obvious, but the IRB needs this specifically addressed.
3. Should subjects be provided with information after participating?
If there are no plans to provide the subjects with information after their participation (i.e, debriefing),
this must be justified. Specifically address whether informing the subjects that they had participated in
the audit study might cause harm to the subjects by adding to the burden of time or by causing
embarrassment.
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