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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