Salem CollegeIRB Long Proposal Form
HUMAN SUBJECT RESEARCH
Dean’s Signature of Pre-approval:- Investigators
- Principal investigator:
- Email:
- Co-investigators:
- Faculty supervisor (if principal investigator is a student):
- Faculty supervisor email:
- Research Project
- Project title:
- Anticipated start date:
- Anticipated completion date:
- Purpose/objective/aims of your research:
- Describe the methods of data collection and record-keeping:
- Specify the setting(s) where the research will be conducted:
Attach copies of all surveys, interview schedules, scripts, images, questions, consent forms, assent forms, tests, calls for participants, and other pertinent documents and materials to be used in the research project. Include copyright permissions where applicable. Attach any approval letters previously obtained for this project from institutional review boards at other institutions, if applicable.
- Participants
Highlight your responses.
- Check all that apply, and provide further information where necessary.
☐Children/minors (under 18 years of age) Age range:
☐ Adults Age range:
☐ Institutionalized persons (e.g., prisoners) Age range:
☐ Impaired persons (e.g., cognitive, psychiatric, or developmental disorders, under the influence of alcohol or drugs) Age range:
Note: This only applies to participants with known impairments relevant to the study.
☐ Other – Explain:
- Anticipated number of participants:
- Institutional affiliation(s) of participants:
- Explain in detail how participants will be recruited and selected:
- Participant payments/incentives/rewards:
☐ No payments, rewards, or incentives for participants
☐ Non-monetary incentives (e.g., extra credit in a class) – Explain:
☐ Monetary incentives – Explain:
- Risks to participants:
Note: “Risk” is defined as the probability of physical, psychological, social, or economic harm or injury as a result of participation in a research study.
☐ No anticipated risks to participants
☐ Some anticipated risks to participants – Explain:
- Benefits for participants:
☐ No direct or indirect benefits for participants
☐ Some direct or indirect benefits for participants – Explain:
- Deception with participants:
Note: Withholding details about the specifics of one’s hypothesis does notconstitute deception. However, misleading participants about the nature of the research question or about the nature of the task they will be completing doesconstitute deception.
☐ No deception with participants
☐ Some deception with participants – Explain the process you will use, why deception is necessary, and a full description of your debriefing procedures:
- Voluntary Participation and Protection of Identity
Note: This section does not apply to unobtrusive observation of public behavior.
Highlight your responses.
- For research involving participants who are minors (under the age of 18), will permission be obtained from the parents/legal guardians?
☐ N/A; participants will not be minors
☐ Yes. (Attach parental consent form)
☐ No. Provide detailed rationale:
- How will you document informed consent and assent (if applicable)? Check all that apply, and attach all consent forms and assent forms.
Note: Assent forms should be used for participants aged 7 – 17in addition to consent forms for guardians of participants.
☐ Signed consent form (for participants aged 18+ or guardians of participants)
☐ Signed assent form (for participants aged 7 – 17)
☐ A “click” formatted consent form prior to the online research process – Explain how you will ensure that viewers cannot proceed to questions unless the consent page is checked, “I Agree”. This agreement includes affirming that the participant is at least 18 years of age.
☐ Verbal consent – Explain your method of providing all necessary participation information to the participants before they consent, why written consent is not being used, and how verbal consent will be recorded.
☐ I will not be documenting consent. Provide detailed rationale:
- Will any information be collected that would allow you or others to directly or indirectly identify the human subjects.
☐ No, all information be collected anonymously.
Note: Anonymous data collection is rare. It means the researcher does not know the identity of any of the participants. Confidentiality is much more common. It is considered confidential, not anonymous, if the researcher knows the identity of any participant, even if no names are recorded in the data.
☐ Yes. Explain in detail how you will protect the confidentiality of the individual participants:
- Do you plan to present, publish, or otherwise distribute information about your research findings?
☐ No.
☐ Yes. Explain:
- Where will the collected data be stored?
- Who besides yourself will have access to your data?
- How long will identifiable data and records linking identities of participants to their data be retained?
- How will identifiable data and records linking identities of participants to their data be destroyed? If not to be destroyed, provide rationale and explain your methods for safeguarding the data over time.
- Signatures
Note: Signatures are not required for proposals submitted electronically.
______
Signature of principal investigator Date
______
Signatures of co-investigators Date
______
Signature of supervising faculty member (if PI is a student) Date
Salem College IRB Guidelines for Informed Consent
The informed consent of participating human subjects in a research project is essential. Give each participant two copies of the Informed Consent Form, one to sign and return to you and one to keep for their records. Below are instructions and sample language for a consent form. Instructions from the IRB are highlighted; make sure no IRB instructions are included in your letter. Non-highlighted text is sample language that you are free to use.
Sample Consent Form:
Invitation to Participate in Research
Project Title: (insert project title)
Researcher(s): (insert name of researcher(s); if more than one, identify the principal investigator)
Faculty Sponsor: (if the researcher is a student, include the faculty sponsor’s name)
Funding Source: (if applicable, identify the funding source(s) for the research)
Introduction:
For a faculty research project state the following:
You are being asked to take part in a research study being conducted by (researcher’s name), a faculty (or staff) member in the Department of (insert department) at Salem College, Winston Salem, North Carolina.
For a student research project state the following:
You are being asked to take part in a research study being conducted by (student name) for a(indicate whether this is a class project, thesis, dissertation) under the supervision of (faculty sponsor) in the Department of (insert department)at Salem College.
You are being asked to participate because (Explain why the person is being asked to participate. For example, if the person is being asked because he or she is a member of a particular group, has had a particular experience, or possesses certain characteristics, explain this here. When appropriate, give the approximate number of participants in the study and describe any exclusion criteria such as age limit, health restrictions, years of education, gender, etc.). Please read this form carefully and ask any questions you may have before deciding whether to participate in the study.
Purpose:
The purpose of this study is (explain the research question or purpose in lay language).
Procedures:
(If this form is for parental consent for a child to participate, the wording should reflect this; “If you agree to permit your child to be in the study…”)
If you agree to be in the study, you will be asked to:
●Explain all tasks and procedures in a language that a layperson can understand and in sufficient detail. For example, if the participants will be asked to participate in an interview, explain the subject matter of the interview, the topic areas that will be covered or types of questions that will be asked, how long it will take, where it will be held, etc. If the interview will be audiotaped or videotaped, state this.
●If the research involves more than one procedure, (i.e. an interview and a survey), use bullet points to list and explain each procedure separately.
●If the research involves different experimental groups, explain how participants will be assigned to groups.
●State the approximate amount of time required for participation.
Risks/Benefits:
●Explain any foreseeable risks or discomforts. If there are no foreseeable risks, you may simply state: “There are no foreseeable risks involved in participating in this research beyond those experienced in everyday life.”
●Explain any benefits to the participant or to society. If the participant will not benefit directly, simply state: “There are no direct benefits to you from participation, but (indicate how the results may be helpful to others or to society).” Financial compensation should not be discussed here, but included in a separate section.
Compensation: (if applicable)
Include this section only if participants will be compensated in some way, (e.g., money, gift certificate, extra credit for a class, etc.). Describe the amount or nature of the compensation and indicate how compensation will be handled if they withdraw.
Costs: (if applicable)
Include this section only if there are special costs to the participant for participation, (e.g., the participants must pay for an activity, etc. In this case, describe the anticipated costs).
Alternatives: (optional section)
Include this section only if this study involves an intervention or a diagnostic procedure and there are alternatives that the person may consider. In this case, explain the alternatives to participating in the research. For example, if there are other interventions or diagnostic procedures that the person may choose, describe them.
Confidentiality:
●Explain the degree to which information gathered will be confidential and explain how it will be kept confidential, (i.e. if data will be coded so that no names appear on any questionnaires, explain the coding system).
●If there are limits to confidentiality, explain these, (e.g., if you are a licensed professional and thus required to report child/elder abuse or neglect, this should be disclosed if the study is likely to elicit reportable information; if others, besides the researcher(s), will have access to the data indicate who will have access, etc.).
●Explain who will have access to the collected data, how it will be stored to ensure confidentiality, how long identifiable data will be retained, and how identifiable data will be destroyed (e.g., shredded).
●If audiotapes or videotapes will be made during the course of the research, explain how the tapes will be stored and what will happen to the tapes at the conclusion of the research.
Voluntary Participation:
Participation in this study is voluntary. If you decide to participate you are free to withdraw at any time without penalty. (If participants currently have a relationship with the researcher or are receiving services from the cooperating research institution, state that their decision to participate or not will have no effect on their current relationship, the services they are currently receiving, grade in the course will not be affected, etc.)
Questions and Contacts:
If you have questions about this research study, please feel free to contact(researcher’s name)at(researcher’s phone number or email address).
Note: If this is a student project, then also give the business phone number and email address for the faculty sponsor.
If you have questions about your rights as a research participant, you may contact the Chair of the Salem College Institutional Review Board by email at .
If the participant is an adult, then use the following statement of consent.
Statement of Consent:
Your signature below indicates that you are 18 years of age or older, you have read and understand the information provided above, and freely consent to participate in this research study.
______
Participant’s Printed Name
______
Participant’s Signature Date
______
Researcher’s Signature Date
If the participant is a minor, then use the following statement of consent.
Statement of Consent:
Your signature below indicates that you have read and understood the information above and you give consent for your child to participate in this study. Your child will also be given the opportunity to assent to participate.
______
Participant’s Printed Name
______
Parent/Guardian’s Printed Name
______
Parent/Guardian’s Signature Date
______
Researcher’s Signature Date
Informed Consent for Non-English Speaking Populations
It is the responsibility of the principal investigator to insure that the information provided during the consent process is comprehensible to the potential participants. If there are non-English speaking participants to be recruited, the consent documents - including both written consent forms and oral consent scripts - should be submitted both in English, and in the language of the target population. The investigator should document the qualifications of the translator, whether themselves or another person, in that language. Are they native speakers or the language? If not, what sort of training have they had? Since the goal of these scripts is effective communication, it's important that the translator have extensive conversational experience in the target language, and not just "academic" training. It is helpful, particularly for protocols that may involve more than minimal risk, to have the consent documents "back-translated" into English, so the IRB can assess whether essential information has been accurately communicated in the target language.
Contact information may require modification with participants in these studies. Participants may not have access to or experience with phones or email, for example; or it may be impracticable to have them phone an international number to contact a supervisor or the IRB office. In such cases, the principal investigator should explain how participants will be provided with appropriate contacts for any questions about the research, or their rights as participants. If the research itself involves direct interactions with participants, it is important that the individuals who will be interacting with participants in these studies be fluent in that language, whether it is merely to be ready to answer questions that might arise during the consent phase, or to conduct in-depth interviews. The investigator should explain who will be interacting with participants, and again describe their qualifications and experience in that language and culture.
Salem College IRB Guidelines for Informed Assent
The following parts should be included in an assent letter, in simple, developmentally-appropriate language. If the child is a non-reader, or a struggling reader, the assent letter can be read aloud. If the child is not a fluent English reader, or does not comprehend spoken English, follow the rules for translation in the adult consent directions.
Description of Study: State the reason for the research, and what the child will be expected to do.
Risks or Discomforts: Rarely will research with children (other than medical) involve physical discomfort, but be sure to mention if topics that could potentially be uncomfortable will be discussed. If there are no known risks or discomforts, say so.
Benefits: Describe any possible benefits to the child, and/or benefits to others who may benefit in the future. If there are no known benefits, say so.
Alternatives to the Study: Describe any alternative procedures to participation in the study. (In educational research, especially, be clear about whether the child will participate in all educational activities, and is solely consenting to the use of data.)
Confidentiality: Explain that the child’s identity and participation will be kept secret, and name those who will have access to the child’s identity and participation.
Participation: Explain that the child can stop participating in the study at any time, and that there is no penalty for stopping. Reassure the child that grades are not affected in any way by the study. Also reaffirm that the child’s parent or parents have already agreed that it is okay to be in the study.
Contact Information: Provide contact information as shown below in the sample letter.
The following sample is intended to help you create an assent document. The text is a suggestion for how to introduce the required elements of an assent form in a way that is easy for a child to understand. Parts may need to be added, deleted, or modified, depending on your study topic and/or research methods. For example, if you are going to videotape or audiotape students, this would need to be covered in the letter. For children ages 14-17, it may be appropriate to use the language in the parental consent. Instructions from the IRB are highlighted in the sample; make sure no IRB instructions are included in your letter. Non-highlighted text is sample language that you are free to use.
Sample Assent Form: Research Participants who are Minors
Invitation to Participate in Research
Project Title: (insert project title)
Investigator: (insert name of investigator(s))
I am doing a research study about (describe the purpose in simple language). A research study is a way to learn more about people. If you decide that you want to be part of this study, you will be asked to (describe the intervention or activities, including dates/time involved).
There are some things about this study that you should know. These are (describe any risks, discomforts, etc.). There may also be benefits to you. A benefit means that something good may happen to you. I think that these benefits might be (insert description of benefits).
Your name will be kept secret from any people who read my study. I will use a number instead of your name. (Alternative: “I will use a pretend name for you, in place of your real name.”) I will keep all of the information with your name on it secret from everyone except (identify others with access).
(For many educational studies:) You will participate in all of the regular classroom activities, whether or not you are in this study. Being in the study just means that I will collect some information about you, like (describe the types of data collection: survey information, quiz and test scores, quotes, etc.).
If you do not want to be in this study, you will not be punished in any way. Your grades will not be affected by being in the study or not. If you decide to stop after we begin, that’s OK too. Your parents know about this study, and they have already agreed that you can be in it if you would like to.
If you want to know more about this study, or have any questions, you can call (study advisor’s name) at (study advisor’s business phone number) or (IRB Chair’s name) at (IRB Chair’s business phone number). If you decide that you want to be in this study, please print and sign your name.
I, ______, want to be in this research study.
______
Sign your name here.Date