UT Southwestern Medical Center
Form C
STUDY POPULATIONS AND RECRUITMENT PLAN
If an item does not apply to your research project, indicate that the question is "not applicable” – do not leave sections blank
Click once on the highlighted entry in each box to provide your response. Click the item number/letter or word, if hyperlinked, for detailed instructions for that question. If your response requires inserting a table, picture, etc, you may need to first delete the box that surrounds the answer and then insert your table or other special document.
|1. Study Population(s). |
|You will be drawing subjects from one or more populations. In medical research, for example, a population can be individuals with type 2 diabetes controlled |
|with diet, or a population of healthy individuals. In social behavioral research, a population can be individuals attending an education program, etc. |
|1.a. How many different populations are you enrolling in this study? |Insert number of different populations here |
|1.b. For each different population, provide a short descriptive label: |1. Insert 1st short descriptive label here |
|(e.g., normal-healthy, diabetics, parents, children, etc.) |2. Insert 2nd short descriptive label here or delete |
|Copy and paste additional labels as needed ( | |
|2. For each specific population identified in 1b, provide the following information in the table provided below. |
|(For studies with more than one population, copy all of table 2. and paste to insert additional tables.) |
|Population # 1 |Population Descriptive Label: Insert the short label used in 1b |
|(1) |Identify the criteria for inclusion: |
|[insert answer #1] |
|(2) |Identify the criteria for exclusion: |
|[insert answer #2] |
|(3) |Recruitment Process – identifying potential subjects |
| |Describe plans about how the population will be identified for the purpose of recruiting. (e.g., database search, personal contacts, referrals,|
| |patients under the care of the research team, etc.) |
| |(Consider Form G (waiver of consent) and Form H, HIPAA Waiver to access (screen) PHI for identification of potential subjects) |
|insert answer #3 here |
|If recruiting from more than one institution and the identification process differ - clearly describe differences here. |
|Describe differences or insert "N/A" |
|(4) |Recruitment Process – first contact |
| |Describe how initial contact will be made with potential subjects |
| |(e.g., researchers will contact potential subjects or subjects will contact the researchers or make appoints to see researchers after learning |
| |of the study). |
| |Describe how those making initial contact have access to the subjects’ identity and the subjects’ information. (Consider whether a Form H, HIPAA|
| |Waiver is needed to disclose PHI.) |
|insert answer #4 |
|If recruiting from more than one institution and the process of making initial contact differs - clearly describe differences here. |
|Describe differences or insert "N/A" |
|(5) |Recruitment process – setting |
| |Describe the setting in which an individual will be initially approached. |
| |(e.g., private room, inpatient unit, waiting area, group setting, over internet, over phone, in public). Also, describe all interaction between|
| |the research staff and the potential subject between the time they contact the research team or vice versa and the time they sign a consent form|
| |(including pre-screening activities-see instructions for detailed guidance) |
|insert answer #5 |
|If recruiting from more than one institution and the setting differs - clearly describe differences here. |
|Describe differences or insert "N/A" |
|(6) |Recruitment process - advertisements |
| |Will any advertising be used? |
|(7) |Consent Process |
| |Describe the consent/assent procedures that will be used by the research team. |
| |Include how: information is provided; the consent interview is conducted; the consent is signed. |
| |Identify the study staff who will conduct the consent interview by their roles (e.g., investigator, research nurse). |
| |* If the consent process of a single subject will involve more than one member of the research team, describe how this process will be |
| |coordinated from start to finish. |
| |** If you expect this population will have individuals likely to have diminished decision-making capacity |
| |(not including incompetent or impaired decision making capacity), describe the assessment process for determining whether the individual is |
| |capable of giving informed consent (i.e., evaluation criteria, time intervals) – refer to Form L for plans to assess competency. |
|insert answer #7 |
|(8) |Consent Process – time between initial contact and obtaining consent |
| |Describe the timing of obtaining informed consent, whether there is any waiting period between informing the prospective subject and obtaining |
| |consent. (e.g., take consent home, waiting period of X hours, after consulting with family members, etc.) |
|insert answer #8 |
|(9) |Describe measures taken to minimize the possibility of coercion or undue influence during consent. |
|insert answer #9 |
|(10) |Will subjects from this population be assigned to different research groups? (e.g., treatment and control group) |
| |[pic] |Yes |[pic] |No |
| | | | | |
|If yes, list the groups by inserting a short descriptive title for each group. |
|E.g., experimental group A, B, etc., control group, etc. |
|insert short title for each group here |
|(11) |Will subjects from this population be non-English Speaking? |
| |[pic] |Yes |[pic] |No |
| | | | | |
|11.a. |If yes, you must have plans for: |
| |1) conducting the consent discussion in the language understandable to the subject, and |
| |2) ongoing communication with the subject throughout the research and in case of emergency. |
| | |
| |Select all that apply to describe how you plan to communicate with non-English Speaking subjects: |
| |☐ At least one member of the research team is fluent in the language that will be used for communication, and that research staff |
| |member(s) will be available during emergencies |
| |☐ The research team has 24-hour access to a translation service with sufficient medical expertise to discuss the research in this |
| |study. |
| |☐ Other (explain): |
|11.b. |Indicate how all non-English subjects will be consented (select all that apply): |
| |☐ Verbal Consent |
| |☐Long Form (consent/information sheet) |
| |☐Short Form |
| |If using the short form translation process, when will you translate the long consent form? |
| |☐ A long form translation will be provided/requested ASAP. See OHRP Guidance on Documenting Informed Consent with Non-English |
| |Speakers |
| |☐ The long form consent will not be translated because the number of non-English speaking subjects in this study is expected to be |
| |low (e.g., less than 3) |
|3. Return of Clinically Relevant Research Results |
|The 2018 Requirements of the Common Rule require investigators to disclose to subjects if clinically relevant research results will be returned to them. If |
|clinically relevant research results will be returned to subjects, please complete the following questions to document the plan to return these results. This |
|does not include returning any results from clinical tests that would otherwise be returned or be available to subjects. |
| |
|For guidance, refer to the MRCT Center Return of Individual Results Toolkit and Guidance Document or contact the HRPPO for more information. |
|(1) |Does this study conduct research-related tests or procedures from which clinically relevant research results could be identified and will these |
| |results be returned to the subjects? |
| |[pic] |Yes (Answer questions 2-9 |[pic] |No (STOP here) |
| | |below) | | |
|(2) |Which populations from 1.b will have clinically relevant research results returned to them? |
| |insert answer #2 |
|(3) |What information from the research tests/procedures will be released? |
| |(i.e., are there valid and useful urgent results/urgent incidental findings, routine results/non-urgent incidental findings, or individual |
| |research study results that may be found on the tests/procedures; note: it is not recommended to return exploratory results) |
| |insert answer #3 |
|(4) |If necessary, how will the results from the research tests/procedures be validated before results are returned? |
| |(e.g., lab tests confirmed in a CAP/CLIA certified lab, result(s) will be reviewed and interpreted by a licensed professional before being |
| |shared with the participants, etc.) |
| |insert answer #4 |
|(5) |Who will return the results from the clinically relevant research tests? |
| |Consider the role of the PI, research nurse, study coordinator, sponsor, etc. |
| |insert answer #5 |
|(6) |How will participant contact information be tracked, accessed, and utilized and how will return of results preferences be tracked and managed if|
| |a result is found? |
| |insert answer #6 |
|(7) |How will the results be returned to the subject (e.g., via phone call, at the next scheduled visit, etc.)? |
| |Consider processes for electronic, paper, and interactive means (including phone calls, electronic forms of communication, or face-to-face |
| |meetings) for sharing results; consider what will be provided to the subject, results with or without interpretation or clinical validation, and|
| |what steps would be necessary for a subject to follow-up on these results. |
| |insert answer #7 |
|(8) |When is this return of results expected to take place (e.g., immediately after the test has been reviewed by the PI, at certain study |
| |milestones, etc.)? |
| |Consider the urgency of the findings, when results will be available, and when they can or must be acted upon (during or after the trial). |
| |insert answer #8 |
|(9) |Will the subject be offered any resources after the clinically relevant research results are returned to them (e.g., genetic counseling)? |
| |Consider whether the results demand a referral for clinical care and who may be responsible for such a referral. |
| |insert answer #9 |
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