Adult Research Participation Consent Form

The IRB requires the researcher to provide an exact copy of the consent form that will be
distributed to potential subjects. Both the researcher and subject must have a copy of the
consent form signed by the researcher and subject before data can be collected from a subject. In
the case of consent for online surveys, the email notifying subjects of the survey and providing
the link to it must inform subjects that they should either (a) print a copy of the consent form
which accompanies the survey, or (b) write down the contact information provided on the
consent form for the researcher and the co-chairs of Institutional Review Board.

Under the Forms Tab on the IRB website there is a separate form for Parental Consent when
potential subjects are less than 18 years of age.

Below are the sections and typical content that are required for a consent form that will enable a
potential subject to make a fully informed consent decision.

Title of Project:
Researcher(s):
Sponsor: This would be a faculty mentor for student researchers, or a Le Moyne College faculty
sponsor for researchers who are not affiliated with Le Moyne College and who intend to recruit
Le Moyne College employees or students as research subjects.

Your consent is being sought to participate in this study. Please read the following information
carefully before you decide whether or not to consent to participate.1

Purpose of the research: Provide a brief overview of what research issues or hypotheses will
be examined with the data collected from subjects. There should also be a brief statement on
what the final product of the research will be, such as a Masters or Honors thesis, conference
presentation, or journal article.

Procedure to be followed: This section must include a description of all the ways that the
researcher will interact with subjects, including informed consent procedures, specific tasks the
researcher will ask subjects to do, and all procedures related to data collection.

Discomforts/risks: The researcher should describe carefully the potential risks (physical,
psychological, social, legal, or other) and assess the likelihood and seriousness of such risks. If
methods are used which create significant risks, an explanation of why these methods were
used and not others is required. What alternative methods are available?

Please note that all research that intends to respect the privacy, confidentiality, or anonymity of
the research participants runs the risk, however remote, that there may be a breach of
confidentiality. This must be identified as a risk in this section. You should also identify the level
of confidentiality that will be maintained.

In addition to the general risks described in the previous paragraph, researchers who plan to use
online surveys must also include the following disclaimer in this section of their consent form:

1
These statements must appear in your consent form.
 Whenever one works with email or the internet, there is always the risk of compromising
privacy, confidentiality, and/or anonymity. Your confidentiality will be maintained to the
degree permitted by the technology being used. It is important for you to understand that no
guarantees can be made regarding the interception of data sent via the internet by third
parties.

Incentives/benefits for participation: This section must include any general benefits, such as
helping to make a contribution to the knowledge of the topic under study, helping specific
groups of people, or providing information that will enable the researcher to make a
contribution to the general well-being of society. Specific benefits, such as receiving payment
for participation or extra credit in a course, must also be included in this section.

Time duration of participation: The researcher must provide an estimate of how much time
the subject can expect to spend participating in the research project. In addition, if subjects will
be completing surveys, they should be told how long they will have to submit their survey
responses.

Statement of confidentiality: If relevant, the researcher should describe particular procedures

(e.g. proper screening of risk-prone individuals, availability of psychological or medical aid,
methods of detecting illness) that will be taken to safeguard the welfare of the subjects. In
studies that intend to maintain confidentiality or anonymity, this refers to an assessment of the
extent to which the names and other private information and data provided by individuals will
be protected by the researcher from release. Describing how the confidentiality of private
information and research data will be maintained is an important component of the informed
consent process.

If anonymity is being claimed, the researcher should describe the procedures by which they will
obtain consent and the data from subjects without having any knowledge of the subjects’
identities.

The researcher also has an obligation to inform potential subjects about the following aspects of
the data collection process: (1) how their data will be presented and used, (2) who will have
access to it, (3) what procedures will be in place to ensure that unauthorized individuals will not
have access to this information, including how it will be stored during the study, (4) what will
become of the data after the completion of the study, and (5) what, if any, limitations exist to
these confidentiality procedures. With regard to how the data will be used, you should mention
how the collected data will be presented in your final product to minimize the risk of disclosing
identities if that is a potential risk. Subjects should be informed of how any written, spoken, or
visual responses will be presented. For example, would you use direct quotes? How would the
individual subjects be referred to in the final product? Similarly, what types of statistical
measures or analyses will be used with quantitative data and to what extent will quantitative
data be disaggregated by subgroup according to type of subject?

In compliance with federal guidelines, all records related to research approved by either
Expedited review (Form B) or Full Board review (Form C), including signed consent forms and
collected data, must be retained in secure storage at Le Moyne College or on a secure Le Moyne
College server for at least three years after the research project has been completed.
Even when names are not linked to specific data, there is always a possibility, however remote,
that a subject’s identity could become known based upon the specific content of their responses
and/or the number and type of subjects who participate. Subjects should therefore be informed
of the number of individuals who will be included in the research project and the size of any
subgroups of individuals who might be identified by their responses. Examples would include
information about age, sex, race, occupation or any other personal characteristics that could
possibly be used to associate an individual or small group of individuals with specific results in
the final product. This is especially important when subgroups defined by potentially identifying
information are used and there are only a small number of potential subjects who could be
classified as members of any subgroup.

The following information must be included (as relevant): (1) whether the subject’s biospecimens
(even if identifiers are removed) might be used for commercial profit and whether the subject will
or will not share in this commercial profit; (2) whether clinically relevant research results,
including individual research results, will be disclosed to subjects; if so, state how they will be
disclosed; and (3) whether research involving biospecimens will (if known) or might include
whole genome sequencing

If the researcher does not apply for broad consent, when the researcher collects private
information or identifiable biospecimens that could be used in future studies, one of the following
two statements must be included:

Identifiers might be removed and the de-identified information or biospecimens may be used for
future research without additional informed consent from the participants.
OR
The participant’s information or biospecimens will not be used or distributed for future research
studies even if identifiers are removed.

Please note: If you include the first statement above, it means that you (or other investigators)
may decide to use the de-identified information or biospecimens in future secondary research
studies approved by the IRB. This is consistent with IRB policies and practices that were already in
place prior to the recent revisions to federal guidelines; the statement that is now required simply
makes this practice explicit for potential research participants. If you include the second
statement, identifiable information or biospecimens collected for your study cannot be used in any
future secondary research studies, without exception. Researchers applying for approval of
secondary research studies will now need to provide confirmation for the IRB that the first
statement above was included on the consent form at the time the data was initially collected (this
applies only to data collected for primary research studies on or after January 21, 2019).

Finally, subjects have the right to know who will have access to your results and/or see your
final product. This would normally include readers of a thesis, as well as any subjects or their
supervisors/administrators who may receive the study’s results.

Voluntary participation: You must inform your subjects that their participation is voluntary. In
addition, you must include a statement that asks them to contact the researcher if they felt
coerced to participate in any way. Finally, if you will interview subjects, administer a survey, or
ask them to answer questions, you must tell them that they are free to skip any question that
they do not want to answer or that makes them uncomfortable. If the nature of the research
design necessitates that participants answer some or all survey questions, a justified rationale
for requiring responses must be provided in the Methods and Procedures section of the Research
Outline (and you would, therefore, not be able to state on the consent form that they can skip any
question that they do not want to answer). In all cases, however, respondents must be allowed to
skip any and all questions that are not absolutely required for the purposes of the research.

Termination of participation: You must tell your subjects that they may choose to withdraw
from the study at any time.

Broad Consent: A researcher may apply for approval of broad consent regarding future use of
collected data that contain identifiable private information and/or identifiable biospecimens. If
applicable, the application for broad consent should be included at this point in the
standard adult research participation consent form. Researchers can use de-identified
information and de-identified biospecimens for secondary research without getting a subject’s
broad consent as long as the secondary research project has been approved by the IRB.
However, if a subject is asked to provide broad consent and refuses, that subject’s data may not
be used for any future secondary research project that relies on broad consent, nor can the
researcher apply for a waiver of informed consent for said project. Please see Attachment 9 of
these Policies and Procedures for additional material on the use of broad consent and the
information that must be provided to research participants on the broad consent form.

Questions regarding the research: Questions regarding the research itself should be directed
to the researcher and to the college sponsor (in the case of student researchers or researchers
not employed by Le Moyne College). Information such as phone numbers and/or email addresses
of the researcher and sponsor should be provided.

Questions or concerns regarding a subject’s rights as a research participant: Questions or

concerns regarding a subject’s rights as a research participant should be directed to the co-
chairs of the Institutional Review Board. They can be reached at irb@[Link].

This research has been reviewed and approved by Le Moyne College’s Institutional Review Board.2

Consent Space: For consent that is obtained on a hardcopy form, the consent form must
provide a space that includes the following:

 A statement for subjects to read such as: I have read all the information provided on this
form, am at least 18 years of age, and consent to participate in this study.
 This statement should be followed by a line on which subjects will sign their name if
they consent to participate and a line for the date. Below the signature line there should
be a line on which subjects can print their name.
 You should include content such as: If you do not consent to participate, you do not
need to sign this form. Simply return it to the researcher.
 You should also provide a line on which you as the investigator will sign your name and a
line on which you write the date for when you sign.

An example of this appears below:

2
This statement must appear on your consent form.
I have read all the information provided on this form, am at least 18 years of age, and consent to
participate in this study.

________________________________________________ ___________________________
Signature Date

___________________________________________________
Please print your name here.

If you do not consent to participate, you do not need to sign this form. Simply return it to the
researcher

Signature of investigator________________________________________________Date_______________________