Instructions:

Note to investigators - Replace all gray boxes with project-specific text and delete instruction boxes. Please do not leave any gray boxes in the final version of the consent form. Boxes can be replaced by simply clicking the box and beginning typing or hitting delete.

Boxes in italicized font are instructions to the researcher and should be deleted entirely. Unformatted text should be replaced with project-specific text.

•  Also be sure to adhere to the following guidelines:

•  Use language understandable to the participants, avoiding technical terminology, scientific jargon, and legalese.

•  The consent form should be written at about an 8th grade reading level for the general population. However, consider your intended population when writing the consent form.

•  Avoid the use of first person language from the perspective of the participant (i.e., language such as "I understand…" or "I agree to…"). Such language can be considered suggestive or coercive.

•  Use Arial 11 point font for ease of reading

•  The form is not locked so you may make formatting changes as needed

•  Be sure to update the version date (in the footer) when any changes are made to the consent form.
Mississippi State University

Informed Consent Form for Participation in Research

Title of Research Study: Title

Study Site: Location

Researchers: Name, Institutional affiliation (e.g, Dr. John Doe, Mississippi State University)

Purpose
The purpose of this research is to [purpose].

Procedures

Detail the procedures and the duration of participation. Identify any experimental procedures as such. For example, "If you participate in this study, you will be asked to complete a survey about [topic] that will take about 10 minutes to complete. The survey will include questions about…"

Risks or Discomforts

Describe any reasonably foreseeable risks or discomforts that might affect the participants. Consider risks other than physical harms, such as criminal or civil liability, damage to participants' financial standing, employability, reputation, insurability, emotional distress, embarrassment, and/or loss of privacy.

Benefits

Include a description of any benefits to the subject or to others which may reasonably be expected from the research.

Incentive to participate

Describe any incentive that will be provided to participants, such as cash payment, gift cards, or extra class credit. Include the specific method of payment (cash, check, gift card, etc.). Include the schedule of payment or information regarding prorated payment if the study consists of multiple sessions or if payment will not be made in its entirety if a participant withdraws early. Note participants are entitled to payment for the time invested in a project, even if they withdraw early. If prorated incentives are not described in the consent form, it will be expected that enrolled participants (i.e., those who have completed the consent process, agreed to participate, and begun the project) will receive full payment or credit even if they withdraw prior to completion of the study.

Alternatives

Describe any appropriate alternative procedures or courses of treatment that might be advantageous to the participant. If this does not apply, delete this section.

Confidentiality

Describe how confidentiality of records will be maintained. If participants will be photographed, video-taped, or audio-taped, include that information in this section.

The following must be included in all PRP research.

Your name and identifying information will not be connected in any way to your responses in this study. The online system will automatically grant you credit when you submit your responses by separately submitting your PRP Identity Code back to the SONA system while your responses are sent to a different database for retrieval by the researcher. If you are participating in a lab study (in-person research), be sure to bring your “Identity Code” (available under the “My Profile” tab on the PRP website) with you to the study, so that you may be granted credit.

Include the following language in all consent forms:

Please note that these records will be held by a state entity and therefore are subject to disclosure if required by law. Research information may be shared with the MSU Institutional Review Board (IRB) and the Office for Human Research Protections (OHRP).

Include the following language for all externally funded research:

The sponsor of this study [Sponsor name] may also have access to the records of the research.

Include the following language only if the study is regulated by the FDA:

All records of this research project may be inspected by the Food and Drug Administration (FDA).

The following language may be required if the study is an FDA-regulated clinical trial (HRPP staff can help you determine if this statement applies to your clinical trial).

A description of this clinical trial will be available on http://ClinicalTrials.gov as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Questions

If you have any questions about this research project, please feel free to contact [Researcher name] at [phone number].

For student research, also include contact information for the faculty advisor.

For questions regarding your rights as a research participant, or to discuss problems, express concerns or complaints, request information, or offer input, please feel free to contact the MSU Regulatory Compliance Office by phone at 662-325-3994, by e-mail at , or on the web at http://orc.msstate.edu/humansubjects/participant/.

Research-related injuries

If the study is physical in nature or is considered by the IRB to be more than minimal risk the following information must be included. If this does not apply, delete this section in its entirety.

MSU has not provided for any payment to you or for your treatment if you are harmed as a result of taking part in this study.

If the study is externally funded, describe the arrangements provided by the sponsor for medical care for a research-related injury (i.e., who will provide care and who will be responsible to pay for it). If the sponsor(s) will not pay for research-related injuries, you may add the sponsor's name(s) after MSU in the statement above (e.g., MSU and NIH have not provided…).

In addition to reporting an injury to [Researcher name] at [phone number] and to the Regulatory Compliance Office at 662-325-3994, you may be able to obtain limited compensation from the State of Mississippi if the injury was caused by the negligent act of a state employee where the damage is a result of an act for which payment may be made under §11-46-1, et seq. Mississippi Code Annotated 1972. To obtain a claim form, contact the University Police Department at MSU UNIVERSITY POLICE DEPARTMENT, Williams Building, Mississippi State, MS 39762, (662) 325-2121.

Voluntary Participation

Please understand that your participation is voluntary. Your refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You may discontinue your participation at any time without penalty or loss of benefits.

If your study will include optional parts to which participants can agree or disagree, but still participate in the overall study, it may be appropriate to include a section for participants to indicate their choices in that regard. Examples might include contacts for future participation, recording of interviews, etc.
Options for Participation
Please initial your choice for the options below:
___The researchers may contact me again to participate in future research activities.
___The researchers may NOT contact me again regarding future research.
Use language such as that in this section if participants will be asked to sign the consent form. Be sure to remove the alternative section below.
Please take all the time you need to read through this document and decide whether you would like to participate in this research study.
If you agree to participate in this research study, please sign below. You will be given a copy of this form for your records.
______
Participant Signature Date
______
Investigator Signature Date
Use language such as that in this section if participants will NOT sign the consent form (i.e.,instances in which documentation of consent may be waived). Be sure to remove the signature section above. If the research will be not be conducted in person, such as internet surveys, revise the language accordingly. For an internet survey, for example, you might instruct participants to click a link if they wish to participate, informing them that they may wish to print the consent page for their records.
Please take all the time you need to read through this document and decide whether you would like to participate in this research study.
If you decide to participate, your completion of the research procedures indicates your consent. Please keep this form for your records.

The following additional elements are required when appropriate. If any of these items are relevant to your research, include them in the text of the consent form above.

1.  A statement that the study may involve risks to the participant that are currently unforeseeable.

2.  A statement that the study may involve risks to the embryo or fetus, if the subject is or may become pregnant, that are currently unforeseeable.

3.  Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the participant’s consent.

4.  Additional costs to the participants that may result from participation.

5.  The consequences of a participant’s decision to withdraw early.

6.  Significant new findings developed during the course of the study, which may relate to the participant’s willingness to continue participation, will be provided to the participant.

7.  The approximate number of subjects in the study (if for example, this might affect confidentiality of information provided or the privacy of participants).

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